Medical Device Daily - March 12, 2013


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Medical Device Daily - March 12, 2013

  1. 1. Tuesday, March 12, 201 3 Vol. 17, No. 48 Page 1 of 1 1American College of Cardiology European Congress of RadiologyWatchman data release saga GE, Philips are stalled in breastputs soap opera plots to shame tomosynthesis but ready to flexBy LARRY HAIMOVITCH By JOHN BROSKYMedical Device Daily Contributing Writer Medical Device Daily European Editor SAN FRANCISCO — The 62nd Annual Scientific Session VIENNA – It’s been another fine year for the establishedof the American College of Cardiology (ACC; Bethesda, players in breast tomosynthesis as they were not troubledMaryland) kicked off here early on Saturday morning with a by the expected arrival of new systems from GE Healthcarenew and surprising turn in a series of unusual events that (Chalfont, UK) and Royal Philips Electronics (Amsterdam,have surrounded the Prospective Randomized Evaluation the Netherlands) (Medical Device Daily, Mar. 7, 2012).of the Watchman LAA Closure Device in Patients With Atrial GE is stuck in the starting gate waiting regulatoryFibrillation Versus Long Term Warfarin Therapy (PREVAIL) approval for the breast tomosynthesis upgrade option oftrial. the Senographe Essential platform. The results from PREVAIL, sponsored by Boston Philips still has not made up its corporate mind aboutScientific (BSC; Natick, Massachusetts), were arguably what to do, if anything, with the prototype it acquired lastthe most eagerly anticipated trial at this meeting. It was year along with the mammography business of Sectrascheduled to be the first trial to be reported on the first day Mamea (Stockholm).in the Late Breaking Clinical Trial session. Early in the week The pioneer in this segment, Hologic (Bedford, See ACC, Page 6 See ECR, Page 7ACC notebook Washington roundupAbbott has long-term positive Medicare virtual colonoscopyresults from ABSORB trial bill introduced again in HouseBy OMAR FORD By MARK McCARTYMedical Device Daily Staff Writer Medical Device Daily Washington Editor Medicare coverage of virtual colonoscopy has been Abbott (Abbott Park, Illinois) reported positive long- a frequent topic over the past couple of years, and Rep.term results for the company’s Absorb Bioresorbable Ralph Hall (R-Texas) has reintroduced legislation that wouldVascular Scaffold (BVS). Three-year results from 101 patients mandate Medicare coverage of the procedure. Should thein the second stage of the ABSORB trial were presented bill pass, the number of CT colonography procedures couldat the 62nd Annual Scientific Session of the American skyrocket, which would translate into a substantial increaseCollege of Cardiology (ACC; Bethesda, Maryland) in San in Medicare spending in the short term, and could provideFrancisco. at least a modest up-tick in sales of CT hardware, given “The data showed that the device is safe and effective,” the tens of millions of Americans who will reach the age ofJonathon Hamilton, a spokesman for Abbott told Medical Medicare eligibility over the next two decades.Device Daily. “There isn’t anything like ABSORB on the Hall, along with co-sponsor Rep. Danny Davis (D-Illinois)market. It’s a fully bioreabsorbable vascular scaffold that offered H.R. 991 on March 6, a bill that will be vetted by theelutes a drug – similar to a drug-eluting stent . . . but the See Abbott, Page 8 See Washington, Page 9 Don’t miss today’s MDD Extra: CardiologyInside: MacuLogix raises $3.6M in ‘A’ funds for AMD diagnostic........................ 2 U.S. only days away from syncing its patent rules. ..................................... 3 To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  2. 2. Tuesday, March 12, 2013 Medical Device Daily™ Page 2 of 1 1Financings roundup Coming WednesdayMacuLogix raises $3.6M in in MDD Perspectives‘A’ funds for AMD diagnosticA Medical Device Daily Staff Report Statistical tinkering in device MacuLogix (Hummelstown, Pennsylvania) said it regulation a disservice to patientshas raised $3.6 million in its Series A funding round.The company says it will use the funds to advance the Despite the regulatory approval of new antiepilepticdevelopment of its diagnostic for the early detection of drugs (AED) over the past decade and the expansionage-related macular degeneration (AMD), a leading cause of of indications deemed suitable for epilepsy surgery,adult blindness. individuals with intractable seizures – roughly one in Investors include Berwind Private Equity, Roche Venture three epilepsy patients – still face a dearth of treatmentFund, Life Sciences Greenhouse of Central Pennsylvania, and options. To read more, see tomorrow’s edition ofBen Franklin Technology Partners of Central and Northern MDD Perspectives, an op-ed e-zine that provides freshPennsylvania. commentary from the MDD Perspectives blog, http:// The company is developing a technology called Plus, you’ll haveAdaptDx for early detection and tracking of AMD. According access to free articles from Medical Device Daily. If youto MacuLogix, the AdaptDx will provide doctors with don’t already receive this complimentary e-zine, go toan easy-to-use, functional diagnostic similar to routine to opt in.perimetry testing for glaucoma. “MacuLogix represents a favorable investment “Closing our Series A round is a very significantopportunity as it addresses a large and growing market achievement for the company,” said John Edwards, CEO offor AMD which is the leading cause of adult vision loss MacuLogix. “We have completed numerous clinical studiesand blindness in developed countries,” said A. Laurence involving more than 1,000 patients with additional studiesNorton, managing director of Berwind Private Equity. “We ongoing, all at major research centers such as Harvardunderstand the AdaptDx has the potential to fundamentally University, the National Eye Institute and University oftransform the way eye doctors detect and manage AMD for Alabama at Birmingham. This financing allows us to take themillions of people worldwide.” next step.” The AdaptDx has received FDA 510(k) clearance for In other financing activity:measurement of dark adaptation function and patient • Lincor Solutions (Dublin, Ireland) said it has securedtesting has been completed to support validation as a a $9.5 million equity investment from Edison Ventures.diagnostic for AMD, MacuLogix noted. However, the device The company expects to add over 30 positions in softwareis not yet cleared for sale as a diagnostic. In addition, the development, sales, marketing, customer support andcompany says the technology is being used by a number of finance roles over the next year in Ireland and the U.S. Lincor’spharmaceutical companies in the development of drugs for MediVista platform delivers secure access to all patient dataearly AMD. See Financings, Page 5 Medical Device Daily™ (ISSN# 1541-0617) is published every business day by AHC Media, 3525 Subscriber Information Please call (800) 477-6307 to subscribe Piedmont Road, Building Six, Suite 400, Atlanta, GA 30305, U.S.A. Opinions expressed are not or if you have fax transmission problems. necessarily those of this publication. Mention of products or services does not constitute endorse- Outside U.S. and Canada, call (404) 262- ment. Medical Device Daily™ is a trademark of AHC Media, a Thompson Media Group, LLC com- 5476. Our customer service hours are pany. Copyright © 2013 AHC Media. All Rights Reserved. No part of this publication may be 8:30 a.m. to 6:00 p.m. EST. reproduced without the ­ ritten ­ onsent of AHC Media. (GST Registration Number R128870672) w c Editorial Holland Johnson, (404) 262-5540 Atlanta Newsroom: Executive Editor: Holland Johnson. Amanda Pedersen, (912) 660-2282 Omar Ford, (404) 262-5546 Washington Editor: Mark McCarty. Mark McCarty, (703) 268-5690 Staff Writers: Omar Ford, Amanda Pedersen. Rob Kimball, (404) 262-5451 Senior Production Editor: Robert Kimball. SVP/Group Publisher Business Office: Senior Vice President/Group Publisher: Donald R. Johnston. Donald R. Johnston, (404) 262-5439 Director of Brand Management: Beth Schilling. Product Marketing Manager: Sarah Cross. Internet Marketing Coordinator: Tessa Turner. Account Representatives: Matt Hertzog, Greg Rouse, Chris Wiley. Reprints: For photocopy rights or reprints, please call Stephen Vance at (404) 262-5511 or e-mail him at To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  3. 3. Tuesday, March 12, 2012 Medical Device Daily™ Page 3 of 1 1U.S. only days away from makers is its broader definition of prior art, which could render a claim unpatentable. Under the new definition, priorsyncing its patent rules art covers disclosures made by anyone, even the applicant,By MARI SEREBROV before the filing of a patent application. This would includeMedical Device Daily Contributing Writer public presentations at a device conference, even if there are no printed handouts. However, disclosures made by the Beginning next week, the U.S. patent system will be in patent applicant within a year of the filing date would bestep with the rest of the world. But to keep pace, the Patent excluded.and Trademark Office (PTO) and industry will have to Because of the expansion of prior art, it is even moremanage a steep learning curve as the nation switches from important for a device maker’s provisional application tofirst-to-invent patent claims to a globally accepted first-to- provide an adequate written description and enablementfile system. to support the priority date for any claimed subject matter, The switch, mandated by the America Invents Act (AIA), said Mary Sylvia, a patent attorney with BakerHostetler.officially occurs Saturday, so it won’t affect applications Under the new law, “there will be much more potentialthat come in under the wire this week. Those claims will prior art that can be raised against a U.S. application,” Sylviabe handled according to the old rules, even though it could told MDD. “So although companies may want to rush to thetake the PTO nearly three years to process them. patent office and be the first to file, unless they flesh out Device makers who can’t file by Friday need “to have that provisional application with adequate support, themechanisms in place to identify new inventions promptly effort may be futile.”and prioritize patent applications for preparation and Companies used to filing internationally should be ablefiling,” Courtenay Brinckerhoff, a partner at Foley & Lardner to take the changes in stride, Sylvia said, as other countriesLLP, told Medical Device Daily. have had similar rules about prior art. The biggest impact She advised them “to use provisional applications could be to university technology transfer offices thatstrategically and to ensure that all pre-filing disclosures, don’t always succeed in trying to keep up with inventor’sincluding offers for sale and sales anywhere in the world, publications, she added. Such failures in the future couldare pre-screened for [intellectual property] purposes.” impact a university’s patent portfolio and out-licensing One of the most challenging aspects of the AIA for device See Patent, Page 4 To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  4. 4. Tuesday, March 12, 2012 Medical Device Daily™ Page 4 of 1 1Agreements/contracts for establishing novel collaborations with clinicaliCAD, Invio combine efforts organizations to expedite early-phase drug discovery. The agreement combines Mayo Clinic’s clinically relevantin MRI solution technology targets with Sanford-Burnham’s discovery platform in aA Medical Device Daily Staff Report translational initiative aimed at advancing a portfolio of projects through the initial stages of drug discovery. The new agreement Invivo (Gainesville, Florida) and iCAD (Nashua, New builds on a yearlong pilot phase and expands the number andHampshire), a provider of imaging and radiation therapy scope of drug discovery projects derived from Mayo Clinictechnologies for the detection and treatment of cancer, researchers that are being conducted at Sanford-Burnham.said the companies have entered into a global research, Sanford-Burnham says it takes a collaborative approachdevelopment, and commercial agreement. to medical research with major programs in cancer, Under the agreement, iCAD will develop advanced neurodegeneration, diabetes, and infectious, inflammatory,MRI image analysis software products which Invivo will and childhood diseases. nincorporate into its suite of MRI product solutions for globalcommercial sale. The first products are anticipated to be Patent Continued from Page 3available in Q2 2013. The initial focus of the partnership willbe the release of a next generation platform for prostate revenue.and breast imaging. Additional new product releases are Just ahead of the switch, the PTO plans to hold a publicalso anticipated beginning the second half of 2013. forum/webcast from 1-4 p.m. Friday to discuss the new rules. Invivo makes innovative RF coils, advanced image Meanwhile, many companies are heeding the advice ofvisualization systems, and MRI-compatible interventional patent experts and racing to get applications filed before theinstruments. new definition of prior art goes into effect. In the past few iCAD is a leading provider of advanced image analysis, months, the PTO has seen a steady increase in the numberworkflow solutions and radiation therapies for the early of new applications submitted. The office received aboutidentification and treatment of common cancers. 100,000 new applications in November, more than 130,000 In other agreements/contracts news: in December and about 170,000 in January, according to its • The Cleveland Clinic (Cleveland) will lend its performance dashboard.expertise to the more than 130 hospitals in 29 states run by Despite all the new applications, the PTO has whittledCommunity Health Systems (Franklin, Tennessee). CHS its backlog from a high of about 722,000 applications inwill gain access to a “quality alliance” already in place at December 2010 to slightly more than 593,000 applicationsthe Cleveland Clinic that can electronically capture, report last month. It’s done that by hiring more patent examinersand compare data about patient outcomes; come up with and reducing the time to process claims.predictive models for improving patient outcomes; and As of February, the patent process from time of filing toshare those best practices across the CHS system. final disposition was taking an average of about 31 months – As part of a five-year agreement, the organizations so long as no request for continued examination (RCE) waswill focus on three areas. In addition to the quality alliance involved. That average is down from more than 35 monthsthat focuses on physicians and data analysis, the Cleveland in October 2010, but it’s still a long way from the PTO’s goalClinic will work to improve cardiovascular services across of 20 months, which the office hopes to hit in 2015.the CHS system, which could lead to more referrals to More impressive is the reduction in time to first action.Cleveland Clinic for tertiary care; and the two groups will In October 2010, the PTO averaged more than 26 monthswork on common issues such as advancing telemedicine from time of application to take its first action. In February,and reducing supply costs. the wait was down to slightly more than 14 months. Both organizations will remain independent and the But those numbers don’t tell the whole story, as morealliance will be guided by a coordinating council that will applications are being put in the RCE pile, where complexhave equal representation from the Cleveland Clinic and CHS. claims can get held up for months or even years. In November • Sanford-Burnham Medical Research Institute (La 2010, the PTO was averaging more than five years to handleJolla, California) and Mayo Clinic (Rochester, Minnesota) an RCE. Now, it’s taking even longer, and the backlog of RCEssigned a new collaborative agreement to build a pipeline of is growing. As of February, it had a backlog of nearly 112,000therapeutic drugs aimed at a variety of diseases with serious RCEs, compared with about 42,000 in August 2010, shortlyunmet medical needs. Under this agreement, Mayo Clinic before the AIA was signed into law.scientists will work with researchers in Sanford-Burnham’s The PTO also is taking longer to handle appeals. InConrad Prebys Center for Chemical Genomics to conduct 2010, the average appeal – from time of initial filing of theearly-stage drug discovery, including assay development, application to a decision from the Board of Patent Appealshigh-throughput screening, and lead identification. Sanford- and Interferences – took more than six years. It’s now takingBurnham, an independent research institute, is recognized more than seven years, according to the PTO. n To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  5. 5. Tuesday, March 12, 2012 Medical Device Daily™ Page 5 of 1 1International report Court reportSt. Jude launches 3-D vessel German grants injunctionreconstruction tech in Japan vs. Elan Med for infringementA Medical Device Daily Staff Report A Medical Device Daily Staff Report St. Jude Medical (St. Paul, Minnesota) reported the Zoll Medical (Chelmsford, Massachusetts) reportedJapanese launch of its Ilumien OPTIS System, a technology that the District Court of Munich, Germany, ruled in itsdesigned to help physicians make personalized stenting favor in granting an injunction against Elan Med (Cologne,decisions based on each patient’s unique anatomy and Germany) for infringing on a Zoll patent through the saledisease state. The Ilumien OPTIS system remains the only of certain Elan products for use with Zoll’s intravascularcombined Fractional Flow Reserve (FFR) and intravascular temperature management (IVTM) systems.Optical Coherence Tomography (OCT) imaging technology Elan has been ordered to stop making and selling theplatform, the company said. Together, FFR and OCT offer infringing products for use with Zoll’s IVTM systems (thephysicians a physiological and anatomical view of the Thermogard XP and CoolGard 300). The court also ruledcoronary vessels to help diagnose and treat coronary artery that Zoll is entitled to recover damages resulting fromdisease. The Ilumien OPTIS system provides enhancements sales of the infringing products that were incurred sinceto the Ilumien system, including a first-of-its-kind stent Jan. 18, 2012 and ordered Elan to pay 90% of the courtplanning software tool. costs. The PressureWire Aeris Wireless FFR Measurement Zoll’s IVTM system is designed to provide coolingSystem collects detailed analyses of blood flow blockages and warming through a balloon catheter inserted into thein the coronary vessels to help determine which specific patient’s venous system. A startup kit is used to connect theblockages are causing the patient’s blood flow to be Thermogard XP or CoolGard 300 temperature managementineffective. The FFR pressure guidewire is directed through console with a catheter to either warm or cool the saline asthe coronary arteries and across the narrowed vessel, taking it flows through the catheter. This approach provides moremeasurements as the guidewire is pulled back through the accurate control of core body temperature than surfacenarrowed part of the artery. methods can, since it directly cools or warms the patient’s The OCT technology in the new Ilumien OPTIS system blood as it flows through the body. nuses the Dragonfly JP Imaging Catheter to capture near-infrared light imaging and measure important vessel Financings Continued from Page 2characteristics otherwise invisible or difficult to assesswith older intracoronary imaging tools. New high at the hospital bedside enabling doctors and nurses toresolution setting and real-time, three-dimensional (3-D) make accurate decisions based on real-time information. Itreconstruction with the Ilumien OPTIS provide a 360-degree also provides access to hospital management systems forpanoramic view of the vessel, which makes it easier for patients and a range of interactive education, entertainmentphysicians to visualize the anatomy they are treating. and communications services that improve outcomes. • Aviv (Chicago), a real estate investment trust thatMazor gets Australian Renaissance order specializes in owning post-acute and long-term care skilled Mazor Robotics (Caesarea, Israel) said LifeHealthcare, nursing facilities and other healthcare properties, said it hasthe company’s distribution and marketing partner in launched an initial public offering of 13.2 million shares of itsAustralia, has ordered its first Renaissance system. The common stock. The estimated price range of the commonsystem will be used for training, marketing, and sales stock is between $18 and $20 a share. The underwriterspurposes, as the distributor’s sales force penetrates the have the option to buy up to an additional 1,980,000 sharesAustralian market. Mazor recently received regulatory of common stock to cover overallotments, if any.approval in Australia. The company’s common stock has been approved for “The system sold marks the first Renaissance to be listing on the New York Stock Exchange under the symbolinstalled in the region and will be used to demonstrate the AVIV. Aviv says it intends to use the net proceeds from thevalue it can bring, helping to increase surgeon accuracy and offering to repay certain indebtedness and for generalimprove patient outcomes. We look forward to introducing corporate purposes, including the potential acquisition ofmore systems to the Australian spinal surgery community additional properties in the ordinary course of surgeons become accustomed with the technology and Morgan Stanley, BofA Merrill Lynch and Goldman,its benefits,” said Ori Hadomi, CEO of Mazor. Sachs & Co. are acting as joint book-running managers Renaissance is transforming spine surgery from of the offering, and Citigroup, RBC Capital Markets,freehand operations to highly-accurate, state-of-the-art SunTrust Robinson Humphrey, RBS and CSCA will act asprocedures, with less radiation, the company said. n co-managers. n To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  6. 6. Tuesday, March 12, 2012 Medical Device Daily™ Page 6 of 1 1ACC within the prespecified criterion for the endpoint: (2) The Continued from Page 1 two other co-primary endpoints were efficacy endpointsleading up to ACC, the full data set, that is both safety and which compared the Watchman arm to the control groupefficacy endpoints, were expected to be presented by the (warfarin) at 18 months. Unfortunately, only 30 of 138 controlprincipal investigator, David Holmes, MD, Scripps professor patients and 58 of 269 device patients have been followedof medicine at the Mayo Graduate School of Medicine for 18 months.(Rochester, Minnesota). The trial missed the second primary endpoint, the However, in an extremely unusual and perhaps comparison between a composite of stroke, systemicunprecedented action, just a few days before the scheduled embolism, and cardiovascular/unexplained death at 18presentation, BSC reported that only the “acute procedural months. The 18-month rate was 6.4% in both groups. Thesafety results” would be presented. No explanation was third primary endpoint, which was a composite of ischemicprovided. A couple of days later, in another bizarre U-turn stroke or systemic embolism occurring after day 7, wasand possibly under pressure from the ACC, BSC reversed its achieved. At 18 months the event rate was 2.53% in theposition and said that the full results of the trial would end device arm vs. 2.01% in the control arm, which met theup being presented after all. prespecified criterion for non-inferiority. Finally, on Saturday morning, just hours before Holmes’ In its ill-timed press release, BSC said that the trialscheduled presentation, BSC put out a press release with the showed that the “device continues to demonstrate positivetrial data, inadvertently violating the ACC’s strict rules about clinical outcomes for patients with atrial fibrillation.”pre-release of clinical trial data. It appeared to be an innocent Due to the embargo break, there was no formaland unfortunate oversight, with the three-hour difference presentation or press conference to discuss PREVAIL.between the East Coast (where BSC is headquartered) and However, in an impromptu meeting with a small cadrethe West Coast (site of ACC meeting) likely causing the early of reporters on Saturday afternoon, Holmes carefullyrelease. explained the rationale for the trial design. In particular he The week’s insanity was capped off by a terse statement discussed the use of a Bayesian adaptive trial design, whichfrom Beth Casteel, media relations director of the ACC, who leveraged off of the PROTECT-AF trial data and reduced thesaid: “The embargo has been broken on the PREVAIL study. number of patients needed to attain statistical significance.The embargo is immediately lifted and PREVAIL will not be Using a Bayesian design allowed the researchers to drawpresented in the late-breaking clinical trial session or the conclusions from the data, even though they had 18 month(ACC) press conference. The embargo was broken when information from only 58 patients who received the deviceBoston Scientific distributed the press release without and 30 patients in the warfarin control group. There has beenembargo early this morning.” So, while the trial was not some debate in the cardiology community about whetherofficially released, the full slide set was obtained by many in this is a large enough cohort to draw accurate conclusionsthe media and the data was quickly disseminated worldwide. but this approach was apparently blessed by the FDA. The basic goal of PREVAIL was to alleviate lingering Holmes said that the safety data in PREVAIL was “giantlyconcerns about the safety and efficacy of the Watchman better” than and “twice as good” as PROTECT-AF. With thatleft atrial appendage (LAA) closure device left over from the goal met and one of the two primary efficacy endpointsearlier Embolic Protection in Patients with Atrial Fibrillation achieved, Holmes said that “it is a real step forward” and he(PROTECT-AF) trial and the follow on continued access voiced cautious optimism that the FDA will approve it.program. Data from PROTECT AF trial, which had been In a research note after the PREVAIL travails, Lawrencereleased at the ACC in 2009, showed encouraging efficacy Biegelsen, senior analyst, medical devices of Wells Fargoresults that met non-inferiority and showed a trend towards Securities (New York) opined that “we think the likelihoodsuperiority of left atrial appendage closure over warfarin. of Watchman approval has been lowered to about 50%-However, safety was compromised by an excess of acute 60% from 90%+ if all three PREVAIL endpoints had beenevents, leaving the LAA arm with over 50% more safety met. Ultimately, we think FDA will require another advisoryevents than the oral anti-coagulation drug therapy (warfarin) committee panel which could push approval out to 2014,arm. Following a positive but lukewarm Circulatory System best case scenario.”Devices Panel meeting also in 2009, the FDA in 2010 decided In another interview with a few reporters, Gordonthat another trial would be required to confirm the safety Tomaselli, MD, professor and director of the Division ofand efficacy of the Watchman. Cardiology at the Johns Hopkins University School of There were three key endpoints to PREVAIL: (1) Medicine (Baltimore) and immediate past president of theAcute (seven day) safety results, which included acute American Heart Association (Dallas) said that the safetyoccurrence of death, ischemic stroke, systemic embolism data from PREVAIL makes him “less hesistant” to use theand procedure or device related complications requiring Watchman for a “select group of patients who have no othermajor cardiovascular or endovascular intervention. This options.”endpoint was met, based on a 2.2% event rate, whiich was See ACC, Page 10 To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  7. 7. Tuesday, March 12, 2012 Medical Device Daily™ Page 7 of 1 1ECR earlier, which is multiple slices and greater detail.Continued from Page 1 The manager for a high-volume radiology operationMassachusetts), further cemented its clinical lead with the based in Stockholm said that after a learning curve,publication in Radiology of results from the long-awaited, radiologists are almost up to the needed speed withlarge-scale study showing, to no one’s surprise, that tomosynthesis at one exam per minute. (MDD, Feb. 22, 2013)exposing women to a double shot of radiation in a screening The tomosynthesis capability for Senographe Essentialexam results in the detection of more cancers. (MDD, Jan. 11, was eclipsed on the GE stand at ECR by the arrival of the2013) U-Systems automated breast ultrasound for its European The Oslo University trial compared conventional digital introduction.mammography with the same exam plus tomosynthesis, In an aside an enthusiastic GE sales rep said thehamstrung by a clinical requirement to always use the company sold 500 units during the Radiological Societyestablished 2-D view mammograms in the massive screening Of North America’s (RSNA; Oakbrook, Illinois) meetingsetting screening technology in parallel with the proposed in Chicago, just weeks after acquiring the company. (MDD,alternative of 3-D-like views rendered from multiple slices Nov. 12, 2012).of tomosynthesis. When Philips purchased the mammographic business At this year’s European Congress of Radiology (ECR) from Sectra (Linköping, Sweden) it acquired digital breastSiemens reported preliminary findings on 9,000 patients tomosynthesis prototypes but is more fascinated with thefrom its own large-scale Malmö breast tomosynthesis potential of the photon counting detector on the MicroDosescreening trial that is bound by the same requirement. unit for standard mammography. GE is preparing to launch from Padua, Italy its own study At ECR 2013, the company actively promoted itstargeting 20,000 women that would remove the training upstream research with the unique spectral imagingwheels from tomosynthesis and see how well it does potential and suggested it may make an end-run ongoing solo, head-to-head against standard mammograms, tomosynthesis by building on MicroDose.according to Christoph Harbereder, the company’s Giving radiologists more information in the standard,communication leader for Europe fast-read format they are accustomed to working with could Luca Giulio, senior mammography product manager prove a powerful differentiation in a very large market.for GE in Europe was less confident about exactly when “Tomo is diagnostics, spectral imaging is screeningGE would be able to upgrade the Senographe machine in with a lot of information that aids in follow-up diagnostics,Padua with the Essential tomosynthesis capability as the said Philips Oliver Bornholdt, Global Market Developmenttechnology has not yet received CE mark approval, though Manager.he said he hoped it would be “soon.” “We are focused on screening and so we are asking GE is also awaiting approval from the FDA. what is the value-added of tomosynthesis in screening?” he Regulatory approval would unlock a tremendous said.opportunity for GE to offer this upgrade to an installed base Dose is a concern in the screening setting where aof more than 2,400 Senographe Essential systems. woman returns every year in the U.S. and every two years in A slow follower in this emerging segment, GE will lead Europe over a 20- to 25-year period.with an enhanced image quality thanks to a step-and- Through-put is a significant concern if compliance andshoot technique for nine exposures in a 25-degree sweep participation goals of payers are to be met.that Giulio insists avoids a blurring found on competitors’ Overall, the intention is to lower the rate of falsesystems that use a continuous motion during the arc of the positives in the screening setting, Bornholdt said, addingprojector tube over the breast. that Philips is now accelerating the work in spectral imaging. Radiation exposure is equivalent to a standard 2-D Once an enhanced spectral imaging platform is provenmammogram, he said. in clinical studies, he said, “We should be able to show some The company literature suggests that once radiologists tomo-like benefits in screening by reducing the recall ratedecide tomosynthesis can take the place of 2D mammograms, but at significantly lower dose.”the cranial-caudal (CC) view will be eliminated so that the The MicroDose detector is called photon-countingdigital breast tomosynthesis mediolateral oblique view because it is able to convert an X-ray photon into electric(MLO) would actually lower the dose compared to a standard charge which can be measured.mammogram. There is a substantial reduction in wasted radiation High volume patient through-put is the last hurdle for energy as a result.tomosynthesis to win a place in screening. Studies continuously show MicroDose reduces The GE exam takes just 10 seconds, making it a contender. exposure to radiation in a standard mammography exam Yet radiologists who can read more than 60 from 18% to 50%mammograms per hour are slowed down by the very points At sponsored symposium at ECR, Pietro Panizza,that make tomosynthesis better able to detect cancers See ECR, Page 10 To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  8. 8. Tuesday, March 12, 2012 Medical Device Daily™ Page 8 of 1 1Abbott outcomes in mortality and major clinical events betweenContinued from Page 1 the Edwards SAPIEN XT transcatheter aortic valve and thedifference between Absorb and a metallic stent is that after Edwards SAPIEN valve, yet fewer vascular events with thethe vessel has healed the Absorb device begins to gradually lower-profile SAPIEN XT valve during the late-breakingbe reabsorbed into the body and it starts to breakdown after clinical trial at ACC.a year. It is fully absorbed over time. When its fully gone it The PARTNER II Trial enrolled 560 patients deemedleaves the vessel without any kind of metallic implant in inoperable for traditional open-heart surgery at 28 hospitalsthe way that a DES metallic stent would leave a permanent in the U.S. between April 2011 and February 2012. Patientsmetallic implant in the artery.” were randomized to receive one of the two Edwards Results from the ABSORB trial presented at ACC showed transcatheter aortic heart valves: 276 received the SAPIENthe rate of major adverse cardiovascular events (MACE) in valve, and 284 received the SAPIEN XT valve.101 patients was 10% at three years, similar to a comparative Analysts called the data favorable and pointingset of data with a best-in-class drug-eluting stent at the specifically to mortality and stroke data saying that it wassame follow-up period. MACE is a combined endpoint that an improvement over PARTNER 1.includes heart attack, death due to heart-related causes, “As expected, mortality was similar between the twoor re-blockage of the blood vessel resulting in symptoms arms with a 30-day rate of 3.5% for Sapien XT and 5.1% forrequiring the need for additional procedures at the original Sapien, and a 1-year rate of 22.5% for Sapien XT and 23.7% forsite of scaffold implantation. Sapien,” Larry Biegelsen an analyst with Wells Fargo wrote. In a subset of 45 patients, imaging techniques showed “Total strokes were also similar between the two arms withimprovements in vasomotion (vessel movement) and a a 30-day rate of 4.3% and 4.1% for Sapien XT and Sapien,7.2% increase in late lumen gain (an increase in the area respectively, and a 1-year stroke rate of 5.9% and 5.7% forwithin the blood vessel) from measurements taken at one Sapien XT and Sapien, respectively. The combined 1-year rateand three years. These findings are unique to Absorb and death or major stroke in the PARTNER 2 study was 23.2%are not typically observed with metallic stents that cage and 25.2% for Sapien XT and Sapien, respectively, whichthe vessel. There was also a decrease in plaque area inside represents an improvement vs. a rate of 33% with Sapien inthe vessel between one and three years. Plaque is typically the PARTNER 1 study. We think the overall improvement in thecomposed of fat, cholesterol, calcium and other deposits rate of death and stroke between PARTNER 1 and PARTNER 2that accumulate in the wall of the artery in patients with is due to the lower-profile NovaFlex delivery system withCAD and can slow or stop blood flow to the heart. less traumatic nose cone; better operator experience and “The three-year data reinforce that Absorb may movement further along the learning curve; and betterprovide unique benefits not possible with metallic stents, patient selection.”including increases in the average area within the blood RBC Capital markets analysts said that FDA approval forvessel, reduction in plaque and improved vessel movement the device could possibly happen by the end of the year.over time,” said Patrick Serruys, MD, PhD, professor of “We expect Edwards to file the PARTNER II data ininterventional cardiology at the Thoraxcentre, Erasmus 2Q13, with FDA approval likely to occur as early as year-University Hospital (Rotterdam, the Netherlands). “As the end,” Glenn Novarro an analyst with RBC wrote. “While thebody of data and real-world experience increase for Absorb, introduction of Sapien XT in the U.S. will allow physicianswe are seeing compelling evidence that a temporary scaffold to treat patients opposed to transapical (thus increasingthat dissolves completely after doing its job represents the the market opportunity), the primary benefit of XT includes:future of interventional cardiology treatment.” faster procedure times; fewer complications; and shorter The company has yet to receive FDA approval for hospital stays. This should translate to hospitals makingthe device, but it is approved in Europe and in about 40 more money on a case.” countries outside of the U.S., Hamilton told MDD. He notedthat the company submitting for FDA approval of Absorb Omar Ford; 404-262-5546;was at least two years out. “We just initiated a clinical trial in the U.S. called theABSORB III trial and we announced that in January of thisyear,” he said. “That’s a trial of up to 2,250 patients acrossa number of sites in the U.S. We’re enrolling that trial. It’s Sign up for our free, weeklya head to head comparison of the Absorb device vs. [the e-mail blog, Perspectives, comment-company’s] Xience metallic DES. We hope to have . . . data ing on today’s med-tech.submitted to the FDA in 2015.” In other ACC conference news; Edwards Lifesciences Go to and sign up.(Irvine, California) reported that preliminary results fromThe PARTNER II Trial demonstrated similar one-year To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  9. 9. Tuesday, March 12, 2012 Medical Device Daily™ Page 9 of 1 1 for this legislation are any better than previous years. HeWashington replied, “we have more evidence than ever about the utilityContinued from Page 1 and value for Medicare patients,” explaining that the bulk ofHouse Ways and Means and the Energy and Commerce the evidence in times gone by was for those aged 50 and upCommittees. The previous version, the CT Colonography rather than using the age of Medicare eligibility as a startingScreening for Colorectal Cancer Act of 2012, never made it point. This additional evidence, he said, “just begs Congresspast committee, however, and the current state of Medicare more than ever to focus attention.”financing will present the move with substantial drag “I think there’s always a struggle for CBO to lookagain this year. On the other hand, some private payers are past” the immediate costs, Connell said of the budgetarycovering the procedure, which puts the Centers for Medicare implications. He said the Congressional Budget Office& Medicaid Services in a tough spot. “doesn’t ascribe a lot of savings to it,” although he asserted In a March 8 statement, Hall said “more than 50,000 that such a policy should save the federal government someAmericans die each year from colon cancer, and one in every money over the long term.nineteen Americans will be diagnosed.” He remarked that the When asked whether this kind of legislation is likely totreatment costs associated with colorectal cancer is as high gain more traction this time around, Connell replied, “theas $30 billion annually, arguing that virtual colonoscopy last year and a half, nobody has been pushing anythingwould “save billions of dollars in treatment [and] prevent through Congress at all” because of major fiscal issues,unnecessary deaths.” thus choking off other considerations. He remarked, “I don’t Gail Rodriguez, executive director of the Medical think the recent history impacts the current prospects.”Imaging & Technology Alliance (MITA; Washington) Connell added that the accumulation of evidence forsaid in a March 11 statement that the association sees CT Medicare eligibles “means that [H.R. 991] should be able tocolonography as a way to “increase compliance in patients move by itself” rather than needing to be packaged withwho otherwise would avoid a diagnostic procedure that other legislation, but he noted that such questions are oftensaves lives.” Rodriguez remarked that “several national up to the leadership in the House and Senate.studies” have demonstrated the value of the diagnostic MDD pointed out that coverage of CT colonography couldservice, adding that among the private payers who cover be handled without a statutory mandate, and asked whetherthe procedure are UnitedHealthcare, Anthem BlueCross/ legislation is really necessary. “I think Congress is signalingBlueShield “and other private insurers.” to CMS that they should cover this,” he said, adding, “I think Medical Device Daily asked Brian Connell, director [administrators at CMS] still have a responsibility to provideof government relations at MITA, whether the prospects beneficiaries with the best care possible” regardless of whether Congress passes a law mandating coverage. Tier 1 PMA goals MDUFMA II Fiscal year PMA/panel/ Exped. PMA 180 PMA PMR PMA/panel modules supps FDA says most MDUFMA II goals met FDA released a report on the second round of 2008 64% 25% 54% 90% medical device user fees in a report that claims a 2009 78% 50% 69% 85% large measure of success. The report, signed by 2010 79% 43% 78% 87% FDA commissioner Margaret Hamburg, MD, says that the Office of Device Evaluation “has already 2011 80% 14% 87% 96% met or exceeded, or has the potential to meet or 2012 100% 100% 70% 97% exceed . . . 23 of 27 tier 1 performance goals,” along Objective 60%/180 days 50%/180 75%/ 85%/ with 20 of 27 tier 2 performance goals for 510(k)s days 90 days 180 days and PMAs. FDA noted that the number of PMAs, panel-track PMAs, and pre-market reports (PMRs) had peaked in Tier 1 and 2 goals for 510(k)s under MDUFMA II 2010 at 53, which the agency noted was a five-year Fiscal year 510(k) tier 1 510(k) tier 2 Total MDUFAII high. However, that number tailed off sharply two 510(k)s 510(k)s years later to 53, the same number as in 2008. 2008 94% 98% 3,901 3,309 The report notes that not all the numbers are 2009 90% 98% 4,153 3,443 in for fiscal 2012, the last year under the Medical 2010 91% 98% 3,935 3,189 Device User Fee Agreement II (MDUFA II), and that hence some of the numbers for 2012 are 2011 95% 99% 3,877 3,258 projections based on the current rate of progress 2012 97% 99% 4,044 3,831 on any applications still outstanding from that Objective 90%/90 days 98%/150 days period. n To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  10. 10. Tuesday, March 12, 2012 Medical Device Daily™ Page 10 of 1 1ACC Lewis noted that “. . . patient appetite for undergoing anContinued from Page 6 interventional procedure to treat a condition already well “PREVAIL definitely allays some of my safety concerns,” controlled by drug therapy is likely to be limited.”he added. Meanwhile, Boston Scientific officials have estimated Tomaselli estimated that about 5% of his patients with the potential market at $500 million within five years. Kenatrial fibrillation might be ideal candidates for the device, Stein, chief medical officer of the company’s cardiac rhythmthough he admiited that this pool may be shrinking with the management group said “we are really optimistic about thisFDA’s approval of three new oral anti-coagulation drugs in . . . we see it as fitting a huge patient need and having a hugethe past three years. amount of data to support it.” Accurately sizing the market potential for any new Boston Scientific acquired the developer of thedevice or procedure is challenging but Biegelsen indicated Watchman, Atritech (Plymouth, Minnesota) in Januarythat “we currently model U.S. Watchman sales of $38 million 2011 with an up-front cash payment of $100 million, within 2014, increasing to $104 million in 2017, and worldwide potential future milestone payments through 2015 worth upWatchman sales of $29 million in 2013 and $159 million in to an additional $275 million. These milestone payments2017.” were based on a combination of regulatory approvals (most David Lewis, another well-regarded medical device likely PMA clearance) and the attainment of certain revenueanalyst from the investment banking firm Morgan Stanley levels. Atritech was founded in 2000 and had raised an(New York) said in a note before the ACC that he believes estimated $100 million from the venture capital communitythe market potential to be about $150 million. In addition, prior to its purchase by BSC. nECR additional radiation, and without contrast agents,” he said.Continued from Page 7 The goal is a standardization with objectiveMD, from the Università Vita Salute San Raffaele in Milan quantification as well as a clear visualization of glandularityreported a 45% reduction in a study of 1,666 women women of density where with standard mammo it can not be40 to 49 years old. distinguished. In a side note, he said he found it funny that the eight The data can be integrated into DICOM headers andwomen radiologists on his team waited for the arrival of DICOM structured reports.the MicroDose unit before scheduling their own mammo Another potential for spectral imaging on MicroDoseexams. is lesion characterization in the screening setting with a The session was chaired by Mats Danielsson of the potential to distinguish cysts from tumors.Royal Institute of Technology in Stockholm, who is also the The upstream research for Philips is being conductedfounder of Sectra. by Matthew Wallis, MD, at the Cambridge Breast Unit of the Sankar Suryanarayanan, Global Mammography Cambridge University Hospitals in England.Marketing Director at Philips Healthcare in Andover After an animated but highly technical explanationoutlined the challenges that motivate the development of of how measuring the attenuation of X-ray energy usingcapabilities unique to the MicroDose platform. the MicroDose platform he was able to successfully First the sensitivity of mammography drops significantly distinguished water from cysts and then a “reasonably goodwith dense breast tissue while the risk of cancer for these separation of spectral characteristics between cyst andwomen is four to six times greater. tumor tissue.” He noted that in the group of younger women studied “We now have a stable method and the approval of theby Panizza the cancer detection rate was 8.2%, where with ethics committee to start a clinical study that will quitestandard mammography it is 2% in this group. probably generate a ‘likelihood ratio’ for characterizing A second issue is that interpretation of mammograms tumors in the screening setting,” he said.remains subjective with studies showing not only a wide This evidence, he said, would then support the start of avariation between readers of the same images but even very large study to validate the ratios.variations by the same reader returning to the same images Meanwhile, Bornholdt said Philips continues to exploreat a different moment. its options with tomosynthesis. Philips is working to add to the MicroDose platform He also confirmed the company is working on ana capability for single-shot spectral imaging that would automated breast ultrasound scanner for the breastquantify breast density and generate maps for breast diagnostic setting.gladularity and thickness. “There is also more coming in other modalities,” he said The results would be highly personal based on cryptically.true data sets acquired from a woman’s exam with no A hint may have slipped during the symposium whenmodeling. Wallis was blunt in expressing his enthusiasm for computed “It is the same exam with no additional views to read, no tomography for the breast. n To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  11. 11. Tuesday, March 12, 2012 Medical Device Daily™ Page 11 of 1 1 Pseudo-SoC analog front end is a very effective approach to Product Briefs implementing vital signs sensors, and extends recent rapid progress in vital sign sensor technologies. • Vital 5 (Logan, Utah), a VentureMD portfolio company, • AMSilk (Planegg, Germany) has produced what it calls has received FDA clearance for ReLeaf, a first-to-market,the world’s first competitive man-made spider silk fiber, dual function catheter system that provides simultaneouscalled Biosteel, which is made entirely from recombinant anesthetic infusion and wound drainage. Continuoussilk proteins. Biosteel has mechanical properties similar to anesthetic infusion to the surgical site in the immediatethat of natural spider silk when comparing toughness, a post-operative period has been clinically proven to providemeasure indicating the kinetic energy absorbed before the significant improvements to pain management, but thisfiber breaks. The current fiber prototypes are smooth to therapy is currently not compatible with the millions ofthe touch, pleasant to the skin and shine like silk. They are surgical cases where a wound drain is prescribed. By offeringbrilliant white and can be dyed with common techniques an integrated system that provides effective continuousused in the textile industry. Applications for Biosteel may local anesthetic infusion while also providing an effectiveinclude high performance technical textiles, sporting goods, wound drain function, the Vital 5 ReLeaf will greatly expandmedical textiles and surgical products, such as meshes and the number of patients who can benefit from local anestheticother support textiles or wound coverings. infusion therapy. • Aspect Imaging (Toronto) reported the launch ofits M2 3-D MR-based histology system for in vivo and exvivo toxicological imaging. The M2 3-D MR-based histology People in the Newssystem is a compact, high-performance MRI instrument forhigh-throughput in vivo and ex vivo imaging of pre-clinical • Amedica (Salt Lake City) has named Karl Farnsworthsamples. The M2 provides all of the benefits of MRI including as chief financial officer. Farnsworth most recently was thehigh-resolution 3-D images of anatomical morphology senior VP and treasurer with Energy Solutions. Amedica is aand quantitative information of disease progression and spinal and reconstructive medical device maker.regression. The M2’s design is based on an innovative • AtriCure (West Chester, Ohio) said Robert White haspermanent magnet design meaning that the magnet does been named to the company’s board. White is currentlynot require costly cryogens to cool and maintain its magnetic president/CEO of Tyrx. AtriCure is a medical devicefield. It is also “self-shielded” and consequently there is company specializing in atrial fibrillation solutions.virtually no external fringe magnetic field. As a result, the • Civco (Coralville, Iowa) has named Hap Petersoncompact MRI can be placed in most locations in a research as VP of North American sales for the radiation oncologylab and it does not require any special infrastructure. business unit. Peterson most recently managed the • invendo medical (New York) has entered the U.S. sales team at Boston Scientific Neuromodulation. Civco’smarket by installing first systems at NYU Langone Medical Radiation Oncology division makes motion managementCenter and NewYork-Presbyterian Hospital/Columbia solutions to improve patient outcomes and increase clinicalUniversity Medical Center. According to the company, productivity for head & neck, breast, lung, abdomen,the invendoscope SC20 has several features that are new prostate and other treatment the field of colonoscopy: it is a single-use colonoscope • Laboratory Corporation of America Holdingswith a working channel; it is not pushed or pulled, but uses (LabCorp; Burlington, North Carolina) said Adam Schechter,a computer-assisted (robotic) gentle drive technology; executive VP and president, global human health, Merck,all endoscopic functions are performed using a handheld has been named to its board, effective April 1. Schechterdevice and; it reduces forces on the colon wall. joined Merck in 1988 as a sales representative and has held • Toshiba (Tokyo) says it has developed an intelligent a number of professional, managerial and executive roles invital signs sensor module, Smart healthcare Intelligent Merck’s global pharmaceuticals business. LabCorp makesMonitor Engine & Ecosystem; Silmee, that simultaneously diagnostic technologies.senses information on key vital signs: Electric Cardio Gram, • SurgiCount Medical (Irvine, California), the whollypulse, body temperature and movements, and that can owned operating subsidiary of Patient Safety Technologies,deliver the data to smartphones and tablet PCs with wireless said Michael Roux has joined the company in the position of VPtechnology. The recently developed Silmee includes a of product management. Roux previously wored at Hill-RomPseudo-SoC analog front end, a 32bit ARM processor chip where he was the global product director for the respiratoryand a dual mode Bluetooth bare chip in a 14.5 mm x 14.5 care franchise. Patient Safety Technologies, through itsmm small package. By adding a few devices to the module, wholly-owned operating subsidiary SurgiCount Medical,such as an antenna, battery and sensor heads, achieves a makes the Safety-Sponge System, a solution clinically provencompletely wearable vital signs sensor system. Among to improve patient safety and reduce healthcare costs bythe chips included in the module, the flexible and compact helping eliminate retained surgical sponges. To subscribe, please call Medical Device Daily™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  12. 12. MDD’s Cardio Extra ADDITIONAL DEVELOPMENTS IN ONE OF MED-TECH’S KEY SECTORS TUESDAY, MARCH 12, 2013 PAGE 1 OF 2Keeping you up to date on recent developments in cardiologyMolecular mechanism identified for response to cardiac stress . . .Myocardial hypertrophy, a thickening of the heart muscle, is an adaptation that occurs with increasedstress on the heart, such as high blood pressure. As the heart muscle expands, it also requires greaterblood flow to maintain access to oxygen and nutrients, necessitating an expansion of the cardiac vascu-lature. In a recent issue of the Journal of Clinical Investigation, Daniela Tirziu and researchers at YaleUniversity (New Haven, Connecticut) identified a molecular mechanism by which the growth of newblood vessels (angiogenesis) and heart muscle growth are coordinated. Using a mouse model of myocar-dial hypertrophy, Tirziu and colleagues determined that nitric oxide triggers the destruction of a proteinknown as RGS4. Nitric oxide typically drives physiological changes associated with the relaxation of bloodvessels, while RGS4 attenuates the activity of a cellular signaling pathway that promotes cardiac growth.The researchers say the findings reveal how increases in heart muscle and blood vessel growth are coor-dinated, linking changes in vasculature to changes in heart size.Heart muscle scar tissue associated with increased risk of deathamong patients with cardiomyopathy . . . Detection of midwall fibrosis (the pres-ence of scar tissue in the middle of the heart muscle wall) via MRI among patients with nonischemicdilated cardiomyopathy (a condition affecting the heart muscle) was associated with an increased likeli-hood of death, according to a study appearing in the March 6 issue of JAMA. Nonischemic dilated cardio-myopathy is associated with significant illness and death due to progressive heart failure (HF) and suddencardiac death (SCD). Despite therapeutic advances, five-year mortality remains as high as 20%. “Riskstratification of patients with nonischemic dilated cardiomyopathy is primarily based on left ventricularejection fraction [LVEF; a measure of how well the left ventricle of the heart pumps with each contraction].Superior prognostic factors may improve patient selection for implantable cardioverter-defibrillators(ICDs) and other management decisions,” according to background information in the article. Attentionhas recently focused on whether detection of myocardial replacement fibrosis (scarring of the heartmuscle) may assist with risk stratification in dilated cardiomyopathy. Fibrosis is associated with contrac-tile impairment. Ankur Gulati, MD, of Royal Brompton Hospital (London), and colleagues evaluatedwhether midwall fibrosis (detected by late gadolinium enhancement cardiovascular magnetic resonance[LGE-CMR] imaging) predicts risk of death, independently of LVEF and other established prognostic factorsin dilated cardiomyopathy. The study included 472 patients with dilated cardiomyopathy referred to a for CMR imaging between November 2000 and December 2008 after presence and extent of mid-wall replacement fibrosis (scarring of the heart muscle present in the middle of the heart muscle wall)were determined. Patients were followed up through December 2011. During a median (midpoint) follow-upof 5.3 years, there were 73 deaths. Overall, 38 of 142 patients with midwall fibrosis (26.8%) died comparedwith 35 of 330 patients without midwall fibrosis (10.6%). After analysis, both the presence and percentageextent of midwall fibrosis were significant independent predictors of all-cause mortality. The arrhythmiccomposite end point (SCD or aborted SCD) occurred in 65 patients (14%). Analysis indicated that patientswith midwall fibrosis were more than five times more likely to experience SCD or aborted SCD comparedwith patients without midwall fibrosis (29.6% vs. 7%). “After adjustment for LVEF and other conventionalprognostic factors, both the presence of fibrosis and the extent were independently and incrementallyassociated with all-cause mortality. Fibrosis was also independently associated with cardiovascular mor-tality or cardiac transplantation, SCD or aborted SCD, and the HF composite [HF death, HF hospitalization,or cardiac transplantation],” the authors write. Also, the addition of fibrosis to LVEF significantly improvedrisk reclassification for all-cause mortality and the SCD composite. “Our findings suggest that detectionand quantification of midwall fibrosis by LGE-CMR may represent useful markers for the risk stratificationof death, ventricular arrhythmia, and HF for patients with dilated cardiomyopathy,” the researchers write. To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  13. 13. TUESDAY, MARCH 12, 2013 MDD’S CARDIO EXTRA PAGE 2 OF 2 Researchers examine thinning of myocardial wall in patients with CAD . . . Among patients with coronary artery disease referred for cardiovascular MRI and found to have regional myocardial wall thinning (of the heart muscle), limited scar burden was associated with improved contraction of the heart and reversal of wall thinning after revascularization, suggesting that myocardial thinning is potentially reversible, according to a study appearing in the March 6 issue of JAMA. Regional myocardial wall thinning is thought to represent chronic myocardial infarction. “However, recent case reports incorporating the use of delayed-enhancement cardiovascular magnetic resonance (CMR) imaging raise the possibility that this viewpoint is incorrect. These single-patient reports indicate that myocardial regions with severe wall thinning do not necessarily consist entirely of scar tissue but instead may have minimal or no scarring. Thus, some areas of myocardial thinning may represent viable myocar- dium and have the potential for recovery of function,” according to background information in the article. Dipan Shah, MD, of Duke University Medical Center (Durham, North Carolina) and colleagues con- ducted a study to evaluate patients with regional myocardial wall thinning and to determine scar burden and potential for functional improvement. The study, conducted from August 2000 through January 2008, included 1,055 patients with known coronary artery disease (CAD) who underwent CMR imaging. “Of 201 patients [19%] identified by CMR as having wall thinning, most had significant left ventricular dysfunction, multivessel CAD, and thinning of a substantial portion of the left ventricle. Among this cohort, 18% of thinned regions had limited or no scarring observed using delayed-enhancement CMR. Because the lack of scarring was associated with significant contractile improvement and reverse remodeling with resolu- tion of wall thinning following revascularization, we believe the data indicate that myocardial thinning is potentially reversible and therefore should not be considered a permanent state,” the authors write. “... we believe our study provides new insights into the pathophysiology of thinned myocardium and more broadly the process of reversible ischemic injury. The data show that thinned myocardium may consist of limited scar tissue and can recover function- concepts that are both inconsistent with current views. In an accompanying editorial, Deepak Gupta, MD, of Brigham and Women’s Hospital (Boston) and col- leagues write that the two cardiovascular imaging studies in this issue of JAMA “address the important issue of how supplemental noninvasive imaging studies can assist the cardiovascular specialist.” Good cholesterol, or HDL, may possess anti-aneurysm forming properties . . . New research provides early evidence that ‘good’ cholesterol may possess anti- aneurysm forming properties. In laboratory-based investigations, scientists found that increased levels of high-density lipoproteins (HDL), the so-called good cholesterol, blocked the development of aneurysms - dangerous ‘ballooning’ in the wall of a blood vessel – in the body’s largest artery, the aorta. The research- ers say their findings – which are published in the American Heart Association (Dallas) scientific journal Atherosclerosis Thrombosis and Vascular Biology - lay the foundations for further investigations into ways of raising HDL cholesterol as a possible therapeutic intervention for the condition. The study, led by researchers from St George’s, University of London, found that elevating the amount of HDL cholesterol in the abdominal area of the aortic artery in mice both reduced the size of aneurysms that had already grown and prevented abdominal aortic aneurysms from forming at all. The researchers say that while more work is needed to understand the exact mechanism by which HDL cholesterol effects aneu- rysms, their investigations indicate that raising HDL cholesterol influences the activity of the aortic artery’s cells, which are the building blocks of its structure and function. They found that elevated levels of HDL had two key influences on the cells. Firstly, it altered the signals sent between cells, which, in turn, reduced the activity of a protein called ERK1/2 that is known for its cell growth properties. Secondly, it increased levels of HDL cholesterol induced programmed cell death, which is an essential part of the cell lifecycle that sees old cells replaced with new ones. The study focused on mice models of the area of the aorta just above the kidney (the suprarenal region) and the region that is just below the kidney and most commonly associated with aneurysm formation in humans (the infrarenal region). The researchers hope that the effects seen in these specific areas of the aortic artery will help explain basic mechanisms of aneurysm formation. The next phase of the investigations, which the researchers hope to begin this year, will see the researchers conduct laboratory tests with families of drugs that can elevate HDLs and repro- duce the observed effects on aneurysms. — Compiled by Amanda Pedersen, MDD Senior Staff Writer To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at