Caracas Asked Interpol to iusseu red notice against allaged med-tech "hoarders"

WEDNESDAY, NOVEMBER 5, 2014 VOLUME 18, NO. 214
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See Cardinal, page 6 See Svelte, page 7
See Latin America, page 8 See Beltway, page 9
INSIDE
INSPIREMD REPORTS DIRECT
OFFERING FOR ALMOST $8M PAGE 2
STRYKER TO PAY AT LEAST $1.4 BILLION
TO SETTLE HIP REPLACEMENT CASES PAGE 3
THE MDD INTERVIEW
LATIN AMERICA INSIDE THE BELTWAY
Washington Editor Mark McCarty
on one of med-tech’s key sectors
Read this week’s Wednesday Special
ONCOLOGY EXTRA
Svelte Medical aims to dominate
transradial stenting stenting market
By John Brosky, Europe Editor
The President & CEO of Svelte Medical (New Providence,
Rhode Island), Jack Darby, brings a deep experience in medical
devices for interventional procedures. He headed the Bayer
Interventional (Whippany, New Jersey) business unit, was Global
Vice President of Sales and Marketing at AGA Medical that was
subsequently acquired by St. Jude Medical (St. Paul, Minnesota)
and held a series of roles with increasing responsibility at Cordis
Cardiology (Bridgewater, New Jersey) including Vice President
of Commercial Operations and Global Stent Marketing. Medical
Device Daily spoke to him from his office at Svelte’s headquarters.
Caracas asked Interpol to issue red
notice against alleged med-tech `hoarders´
By Sergio Held, Staff Writer
The Venezuelan government asked Interpol last week to
issue a red notice to detain three people whom, it claims, are
hoarding medical devices in the Latin American country.
“Those bourgeois left the country months ago. I’m going to
apply for an Interpol red notice, and I swear as my name is Nicolás
Maduro that I will bring them prisoners to Venezuela . . . [It is]
enough with the abuses against the people! This is a battle of all,
nobody guard down!,” exclaimed Venezuelan president Nicolás
Maduro in a public speech at a warehouse full of med-tech that
was raided by government officials, led by the president himself,
Cardinal Health receives approval for
additional indications for MynxGrip
By Omar Ford, Staff Writer
Cardinal Health (Dublin, Ohio) said that its MynxGrip
Vascular Closure Device recently received FDA approval for use
to close femoral veins. The MynxGrip device is now indicated for
use to seal 5F, 6F and 7F femoral arterial and femoral venous
access sites.
The venous indication could help interventional healthcare
providers increase efficiency of their labs and minimize potential
complications associated with venous closure by replacing the
need for manual compression. The MynxGrip device is intended
to reduce times to hemostasis and ambulation, thereby
potentially shortening post-procedure recovery times.
“This indication fits our mission to deliver great patient
CMS creates new HCPCS codes for
breast tomography in OPPS for 2015
By Mark McCarty, Washington Editor
The Centers for Medicare & Medicaid Services (CMS) released
the final Medicare physician fee schedule for calendar year 2015,
adding in a new code under the healthcare common procedural
coding system for 3-D mammography. The news is a big gain for
at least two firms in the tomosynthesis space, Hologic (Bedford,
Massachusetts) and GE Healthcare (Chalfont, UK), and was
abetted at least in part by correspondence from Congress urging
CMS to break open a new code for the technology.
CMS released its proposal for the 2015 MPFS at the
beginning of July, and published the final along with the final

WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 2 OF 10
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FINANCINGS
See Financnings, page 6
InspireMD reports direct
offering for almost $8M
Staff Report
InspireMD (Boston), a developer of in stent embolic
protection systems (EPS), has entered into a definitive agreement
to sell approximately 6.2 million shares of common stock and
warrants to purchase up to almost 3.1 million shares of common
stock in a registered direct offering. The common stock will be
sold at a negotiated purchase price of $1.30 per share, and each
purchaser will receive a warrant to purchase 0.5 of a share of
common stock for each share of common stock that it purchases
in the offering. The warrants shall be non-exercisable for six
months and have a term of exercise of 42 months from the date
of issuance and an exercise price of $1.75. The company expects
to receive gross proceeds from the offering of approximately $8
million, before deducting placement agents’ fees and estimated
offering expenses.
The offering is expected to close on or about Nov. 7, subject
to customary closing conditions.
H.C. Wainwright & Co., served as the exclusive placement
agent for this offering.
The company intends to use the net proceeds from this
offering to advance the development of its MGuard drug-eluting
stent platform and develop the CGuard rapid exchange platform,
commercially launch CGuard EPS, and for general corporate
purposes.
InspireMD seeks to use its proprietary MGuard with
MicroNet technology to make its products the industry standard
for embolic protection and to provide a superior solution to the
key clinical issues of current stenting in patients with a high
risk of distal embolization, no reflow and major adverse cardiac
events.
In other financing news:
• Healthcare Trust of America (HTA; Scottsdale, Arizona)
reported the pricing of its underwritten public offering of
8,000,000 shares of its common stock at a price to the public
of $12.55 per share. HTA has granted the underwriters a 30-
day option to purchase up to 1.2 million additional shares of its
common stock.
HTA will receive approximately $100.4 million in gross
proceeds, before deducting underwriting discounts and
commissions and estimated offering expenses. HTA intends
to use net proceeds from the offering to repay a portion of the
outstanding indebtedness under the senior unsecured revolving
credit and term loan facility and for general corporate purposes,
including, without limitation, working capital and investment
in real estate. Closing is expected to occur on or about Nov. 7,
subject to customary closing conditions.
J.P. Morgan and Wells Fargo Securities are acting as the joint
book-running managers for the offering. BMO Capital Markets,
PNC Capital Markets and Raymond James are acting as the lead

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Stryker to pay at least $1.4 billion
to settle hip replacement cases
Staff Report
Stryker (Kalamazoo, Michigan) said it has reached a
settlement agreement to compensate U.S. patients who had
surgery to replace their Rejuvenate Modular-Neck hip stem and/
or ABG II Modular-Neck hip stem before Nov. 3. Stryker said it
expects to pay at least $1.425 billion to resolve the cases but that
the ultimate cost to entirely resolve the matters will depend on
“many factors that are difficult to predict and may be materially
different than the amounts accrued to date.” The company said
it expects to make most of the payments under the agreement
by the end of 2015.
The settlement follows a early mediation program initiated
by New Jersey Superior Court Judge Brian Martinotti and efforts
by the chief mediator, former United States Magistrate Judge
Diane Welsh. The mediation process led to the resolution of
multiple suits and claims pending in the federal courts and other
states, Stryker noted. The settlement involved the company’s
subsidiary, Howmedica Osteonics (Mahwah, New Jersey), doing
business as Stryker Orthopedics.
“The health and well-being of patients is Stryker’s top
priority,” said Bill Huffnagle, president of the reconstructive
division at Stryker Orthopaedics. “Following our voluntary recall
and our patient support program for recall related care, this
settlement program provides patients compensation in a fair,
timely and efficient manner.”
The settlement resolves more than 3,000 Stryker hip
lawsuits and the company will pay a base award of $300,000
per failed implant, with additional compensation for those who
suffered complications during revision surgery to remove the hip
implant.
The Stryker hip implant lawsuits were filed on behalf of
patients who received the Rejuvenate and ABG II Modular-Neck
Hip Stems and allege the hip implants cause tissue damage,
metal poisoning, degeneration of bone tissue and other serious
health complications. The Stryker hip lawsuits contend that
the medical devices are defective and many patients required
revision surgery to remove their Stryker artificial hip implant
while other patients will likely need revision surgery in the future.
Stryker recalled its Rejuvenate and ABG II Modular-Neck
Hip Stems in July 2012 due to the potential of the medical
devices to fret and corrode at the modular-neck junction. In its
explanation for the recall, Stryker said the neck components of
the Rejuvenate and ABG II are made of chromium and cobalt,
and the stems are coated with titanium. According to Stryker,
the neck components can wear against each other and create
metallic debris, which is released into an implant recipient’s
tissue or bloodstream. The shedding of metallic debris can
result in patients experiencing adverse local tissue reactions,
swelling, pain and other problems, according to Stryker. Stryker
recommended that surgeons consider performing blood
work and imaging on their patients who received the recalled
hip implant devices regardless of whether their patients are
experiencing pain or swelling. //
• BIND Therapeutics (Cambridge, Massachusetts), a clinical-stage
nanomedicine platform company developing targeted and
programmable therapeutics called Accurins, has named Hagop
Youssoufian as chief medical officer. In this position, Youssoufian
will be responsible for overseeing the clinical development and
operations of BIND’s internal pipeline. Edward Schnipper, who
has been serving as interim CMO since January, will continue
in an advisory role. Prior to joining BIND, Youssoufian served as
executive VP of R&D at Progenics Pharmaceuticals.
• Relmada Therapeutics (New York), a clinical-stage company
developing therapies for the treatment of chronic pain, said it has
named Michael Becker as senior VP of finance and corporate
development, effective immediately. Becker brings more than 20
years of experience as a C-level industry executive and Wall Street
securities analyst. Most recently, he was founder and president of
the consulting firm MDB Communications. Relmada Therapeutics
makes novel versions of proven drug products together with new
chemical entities that potentially address areas of high unmet
medical need in the treatment of pain.

DAILY M&A
AGREEMENTS/CONTRACTS
Vascular Solutions to distribute
PolarCath dilatation system
Staff Report
Vascular Solutions (Minneapolis) has entered into an
agreement with NuCryo Vascular (Sunnyvale, California) under
which Vascular Solutions will serve as exclusive distributor of the
PolarCath Peripheral Dilatation System in the U.S.
Vascular Solutions expects to begin sales of PolarCath to
customers through its direct U.S. sales force during the first
quarter of 2015. Vascular Solutions is projecting between $3
million to $5 million in PolarCath sales during 2015.
The PolarCath Peripheral Dilatation System has FDA
clearance to dilate stenosis in the peripheral vasculature
(iliac, femoral, popliteal, infrapopliteal, renal, and subclavian
arteries) and for the treatment of obstructive lesions of
polytetrafluoroethylene (PTFE) access grafts or arteriovenous
dialysis fistulae. The PolarCath system is also indicated for post-deployed
stent expansion of self-expanding peripheral vascular
stents.
“We are very excited to add PolarCath to our broad line of
clinical solutions for the treatment of vascular disease,” said
Howard Root, CEO of Vascular Solutions. “PolarCath, an FDA
cleared device with more than a decade of extensive clinical
experience, is an important tool for the treatment of peripheral
arterial disease. The product is a natural fit for our U.S. direct
sales force and our focus on meeting the needs of interventional
physicians.”
The PolarCath Peripheral Dilatation System consists of
a disposable catheter, an inflation unit, and a nitrous oxide
cartridge. The system is used to perform balloon cryoplasty,
a catheter-based treatment that combines the inflation of a
balloon with controlled cooling of the artery. PolarCath is used
to dilate peripheral arteries with the same basic technique as
balloon angioplasty, except that PolarCath uses nitrous oxide to
inflate the balloon rather than liquid. The nitrous oxide cools the
balloon to minus ten degrees Celsius, which freezes the built-up
plaque in the artery. The PolarCath system was invented by
James Joye, Chief Medical Officer of the Fogarty Institute at El
Camino Hospital (Mountain View, California).
Vascular Solutions is a medical device company that
focuses on developing unique clinical solutions for coronary and
peripheral vascular procedures.
In other agreements: Foundation Medicine (Cambridge,
Massachusetts) and COTA (Hackensack, New Jersey) reported
an agreement to capture and analyze comprehensive genomic,
clinical outcome, and cost data from patients who have
undergone testing with FoundationOne. The resulting dataset is
designed to provide health care providers and payers with the
supporting clinical outcomes and costs evidence that inform
value-based reimbursement decisions and cancer treatment.
“Eliminating inefficiencies and improving patient care
requires actionable insights supported by complete, integrated
data,” said Eric Schultz, CEO of COTA. “This unprecedented
collaboration with Foundation Medicine incorporates the most
comprehensive genomic profiling data with COTA’s unique
real-world, longitudinal clinical outcomes and cost of care data
to provide insights that enable both physicians and payers to
move toward value-based treatment and reimbursement
practices.”
The collaboration will first capture clinical outcomes for
patients with Stage IV non-small cell lung cancer (NSCLC), the
leading cancer killer of men and women in this country, who
have undergone testing with FoundationOne. The resulting
longitudinal data will aim to further demonstrate the clinical
utility of comprehensive genomic profiling for patients with Stage
IV NSCLC and to inform potential value-based reimbursement
decisions from payers. The combination of genomic data,
clinical information, outcomes data and economic data will
provide critical insights for both payers and physicians to fully
endorse the clinical and economic benefits associated with the
application of comprehensive genomic profiling in this disease
setting.
Foundation Medicine is a molecular information company
dedicated to a transformation in cancer care in which treatment
is informed by a deep understanding of the genomic changes
that contribute to each patient’s unique cancer.
FoundationOne is a genomic profile for solid tumors used
by oncologists to identify the molecular alterations in a patient’s
tumor and match those alterations with relevant targeted
therapies and clinical trials. //
American CareSource completes
acquisition of MedHelp Urgent Care
Staff Report
American CareSource (Dallas), operator of urgent care
centers and a national network of ancillary healthcare providers,
said it has completed its acquisition of MedHelp Urgent Care
(Alpharetta, Georgia), a full-service urgent and primary care
provider.
The MedHelp facility provides urgent and primary care and
occupational medicine. In addition, the facility serves a growing
population of military veterans that reside throughout the
southeastern United States.
The company now has eight total centers throughout the
southeastern U.S., three of which are in the greater Atlanta
metropolitan area.
“We anticipate system-wide growth by capitalizing on the
centers’ strategic opportunities,” said Richard Turner, chairman/
CEO. “We also expect to leverage MedHelp’s existing staff to
create efficiencies with our other Atlanta-area centers.” //

WORLD IN REVIEW
STAAR gains final step in regulatory
approval for Visian ICL product in China
Staff Report
STAAR Surgical (Monrovia, California) a developer of
implantable lenses and delivery systems for the eye, reported that
it has received the Approval Certification from CFDA to market its
Visian ICL with CentraFLOW technology in China effective Nov.
3. The Visian ICL with CentraFLOW uses a proprietary port in the
center of the ICL optic, KS-AquaPORT, intended to optimize the
flow of fluid within the eye without affecting the quality of vision.
The CentraFLOW technology eliminates the need for surgeons
to perform a YAG peripheral iridotomy procedure days before the
ICL implant, simplifying the procedure and increasing patient
comfort while providing the superior visual outcomes of the ICL.
“China is currently the largest market in the world for
refractive procedures and the approval of the Visian ICL with
the CentraFLOW technology builds on the momentum of our
already quickly growing line of ICL products in this important
focus market” said Don Todd, president of the Asia Pacific
Region. “We have seen a very positive impact in other markets
with the introduction of the CentraFLOW technology. Visian
ICL procedures today represent about 2% of the more than
875,000 annual refractive procedures in China. We now have
the opportunity to further expand our share and growth in
China, which included a 27% ICL revenue growth milestone in
the most recent quarter. The first orders for the Visian ICL with
CentraFLOW have been placed and will begin to ship this week.”
STAAR Surgical personnel in China began marketing the new
technology on Monday. To date, the company said in a statement
that more 400 surgeons have been trained on the Visian ICL
technology and additional surgeon training is already underway.
There will be a CentraFLOW training course in China for surgeons
in November followed by two additional training courses before
year end. Distributors in China were trained at a recent meeting in
September and additional training will take place in November.
The steps this year in the CentraFLOW’s approval process in
China started with a successful Experts Panel Meeting on May
15 which was followed by the Technical Recommendation from
CMDE on Sept. 24 and the Marketing Approval from the CFDA
on Oct. 29. The approval includes both the Myopic ICL and the
Toric ICL with expanded approval ranges for both myopia and
astigmatism. This increases the potential number of patients
that can be treated with the Visian ICL in China. The range of
myopia correction approved is -0.5 diopters to -18.0 diopters vs.
the previous range of -2.5 diopters to -18.0 diopters equivalent
in BSS. The range of astigmatism correction approved is +0.5
to +6.0 diopters versus the previous range of +0.75 to +4.75
diopters equivalent in BSS. The previously approved ICL was
stored in sodium chloride while the Visian ICL with CentraFLOW
will be stored in BSS.
Cardiovascular Systems receives
CE mark for Stealth 360º OAS
Cardiovascular Systems (CSI; St. Paul, Minnesota) reported
that it has received the CE mark for its Stealth 360º Orbital
Atherectomy System (OAS). Stealth 360º is a percutaneous OAS
that is indicated to treat patients who suffer from peripheral
arterial disease (PAD).
“Securing CE Mark for Stealth 360º greatly expands our
market opportunity and is an important milestone toward
benefiting patients in Europe suffering from PAD—especially
those with critical limb ischemia, (CLI) who have been
underserved by other treatment options,” said David Martin,
CSI president/CEO. “A determining factor for CLI is calcium
buildup in leg arteries, particularly small vessels below the
knee. Our technology, with its unique mechanism of action, has
demonstrated it can safely and effectively treat this complex
disease, with lasting results.”
Stealth 360º will be available in Europe with a 0.014”
guide wire platform, and crown sizes of 1.25 mm, 1.50 mm,
1.75 mm and 2.00 mm. The system consists of the following
main components: Orbital Atherectomy Device, Saline Pump,
Atherectomy guide wire and Atherectomy lubricant—all of which
received CE mark. //
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THe daiLY MediCaL TeCHnOLOgY neWs sOURCe
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See GE Healthcare, page 5 See Beltway, page 6
See Asia, page 7 See ESC, page 8
inside
AcuFocus completes $21 million
Funding in oversubscribed round page 2
novAtion enters heArt vAlve
cAtegory Along with edwArds page 3
InSIdE tHE BEltwAy
REpoRt FRom ASIA EuRopEAn SoCIEty oF CARdIoloGy 2014
executive editor holland Johnson
on one of med-tech’s key sectors
Read this week’s thursday Special
orThopedICs eXTra
Advamed ‘gravely concerned’ about
features of march classification rule
FdA’s march 25 announcement in the Federal Register
regarding a proposed overhaul to the medical device
classification regulation has prompted some pushback,
including from the advanced Medical Technology association
(Advamed; washington). Among the concerns expressed by the
association is that the agency’s calculation of the time needed
to prepare a pmA for a device shifted from class ii to class iii is
off by almost an order of magnitude, but Advamed also said it is
“gravely concerned regarding the wide-ranging impact of these
proposed revised regulations.”
with better regulation, India
steps up into global device market
By T.V. Padma, Contributing Writer
india, which has the fourth largest market in Asia for
medical devices and diagnostics, is planning a series of steps
to strengthen regulation of the sector whose products range
from small thermometers and surgical needles; to implantable
heart valves, stents, heart lung machines and large magnetic
resonance imaging machines.
the indian government is engaged in improving regulation
of drugs, cosmetics and devices, said nandini Kumar, former
deputy director general at indian council of medical research
and adjunct professor at Kasturba medical college in manipal.
philips retools ultrasound
platform to target broad market
By John Brosky, Europe Editor
After introducing a new ultrasound architecture at last
year’s congress of the european society of Cardiology ( esc;
sophia Antipolis, France) with the premium epiQ system,
philips Healthcare (Amsterdam, the netherlands) extended the
line at esc 2014 by introducing a reconfiguration of the platform
as the new Affiniti brand.
targeting clinics with high patient through-put, the two
new Affiniti models provide a range of options to lower the price,
expressed as the total cost of ownership.
“we studied this group extremely well because we really
FdA approves GE’s SenoClaire for
sharper 3-d breast imaging
By Amanda Pedersen, Senior Staff Writer
the FdA has approved a new breast tomosynthesis solution
from ge Healthcare (chalfont, uK) that is designed with a 3-d
imaging technology. ge developed senoclaire in collaboration
with Massachusetts general Hospital (mass general; boston).
the technology uses a low-dose short X-ray sweep around the
positioned breast with nine exposures acquired with a step-and-
shoot method, removing the potential motion from the
tube, helping to reduce blur and increase image sharpness, the
company said.
daniel Kopans, a senior radiologist in the breast imaging
division of the radiology department at mass general, said the
approval marks a key milestone towards providing “cutting

Cardinal
Continued from page 1
Financings
care while being fiscally responsible,” Ariel Sutton, VP of
marketing for Cardinal Health Interventional Solutions,” told
Medical Device Daily. “With the MynxGrip device physicians can
achieve hemostasis more quickly and ambulate patients sooner
compared to manual compression. What this means is that
institutions can increase throughput, which in turn allows for
more procedures in a single day.”
The MynxGrip Vascular Closure Device uses an extravascular
grip sealant that actively adheres to the vein for a secure
mechanical closure and dissolves within 30 days, leaving
nothing permanently behind in the healed vein. The safety
profile of this secure extravascular sealant makes the MynxGrip
device uniquely for venous closure, as it does not leave behind an
intravascular component.
“In addition, there are no changes to the MynxGrip device
design,” she said. “So there are no changes in how the physicians
are really utilizing the product. We will be spending some time
educating the market and informing them that we now have a
new indication.”
Shaden Marzouk, VP of Clinical Affairs for Cardinal Health
noted, “The venous indication for the MynxGrip Vascular
Closure Device is an example of innovative applications for
an interventional suite offering that is differentiated in the
marketplace. We know that these high quality, value-priced and
patient-centered solutions are extremely important in today’s
evolving healthcare landscape.”
Cardinal Health said that it now has the ability to reach a
larger patient populace with the indication.
“We’ll expand the market for the device,” Sutton, told MDD.
“It really opens the market to closing veins and there’s no other
vascular closure device on the market today that’s promoting
this kind of indication.”
The original Mynx device received the CE mark in January
2007 and received initial FDA approval in May 2007. The device
uses a soft, sponge-like sealant material to close the small hole
in the femoral artery. The sealant works by rapidly absorbing
blood and fluids around the puncture site, swelling in size and
covering the hole. This seals the hole and stops the bleeding.
The sealant material consists of polyethylene glycol (PEG),
a water-soluble, non-thrombogenic, conformable, bio-inert
polymer. PEG has an established safety profile and various forms
of PEG are commonly used in a range of consumer and medical
products including toothpaste, skin cream and lubricant eye
drops.
Cardinal Health first gained access to the MynxGrip
Vascular Closure Device, when it revealed its intent to acquire
AccessClosure (Santa Clara, California) back in April (Medical
Device Daily, April 4, 2014). Cardinal acquired the small private
firm for $320 million.
Cardinal has recently been successful in its growth efforts.
Last year the firm’s medical business had $2.8 billion in revenue
in its fiscal second quarter, a 13% increase from the previous
year. Profit was up 40%, to $131 million. AccessClosure’s annual
sales are more than $80 million, driven by a direct sales force.
For a little more than a year Cardinal Health has been
expanding its role on the med-tech landscape. In February 2013,
the company made substantial inroads into into the sector
when it reported plans to acquire AssuraMed (Twinsburg, Ohio),
a provider of medical supplies to patients in the home, for $2.07
billion, or $1.94 billion, net of the present value of tax benefits
(Medical Device Daily, Feb. 15, 2013). The acquisition came on
the heels of AssuraMed’s acquisition of InvaCare (Elyria, Ohio)
in December 2012 for $150 million. //
managers for the offering.
HTA is a full-service real estate company focused on
acquiring, owning and operating high-quality medical office
buildings that are predominantly located on or aligned with
campuses of nationally or regionally recognized healthcare
systems in the U.S.
• Fuel3D (Oxford, UK), a maker of 3-D scanning solutions,
reported that it has closed a funding round totaling $6.4 million
(£4 million). This funding builds on the company’s initial $2.6
million (£1.6 million) funding secured earlier this year and paves
the way for the commercial launch of the company’s consumer
scanner product in 2015.
The funding round was led by Chimera Partners and will be
used to ramp-up Fuel3D’s production, customer support and
international retail distribution after it delivers on its Kickstarter
and pre-order commitments.
In addition, Fuel3D will use the funding to expand the
scope of the company’s technology to address commercial
opportunities in a range of vertical markets through its Fuel3D
Labs division, including biometrics and eyewear.
“The initial interest shown by investors in Fuel3D has only
been increased since the first funding round and we are very
pleased to have been oversubscribed in this round of fundraising,”
said Ben Gill of Chimera Partners and Chairman of Fuel3D. “The
company continues to impress with its commitment to product
development goals and has also made very significant inroads
into developing new commercial applications and relationships.”
In 2013, Fuel3D raised more than $300,000 for the
development of an affordable, high resolution handheld 3-D
scanner through its successful crowdfunding campaign on
Kickstarter. The company has expanded rapidly in response
to global demand and now has distributors in 23 countries
around the world as well as manufacturing operations in
Asia. //

Svelte
MDD: What drew you to Svelte Medical?
Darby: When I was approached by Svelte’s chairman of the
board, Bob Croce, my initial reaction was ‘does the world really
need another drug-eluting stent’ (DES)? The DES market is fairly
mature with highly refined technology and clinical data pretty
much a wash across all platforms. But after stepping back
to thoughtfully assess the opportunity, I realized Svelte had
something truly remarkable. By incorporating a stent onto an
integrated wire platform, the Integrated Delivery System (IDS)
simplifies percutaneous coronary intervention. Reducing the
number of steps necessary to complete a procedure extracts
time and cost from interventions. This benefits all constituents
involved with stenting procedures – patients, physicians,
providers and payers. No other stent technology does this.
The roughly $5 billion stent market also surprisingly lacks real
product differentiation. With the world’s lowest profile system,
Svelte has the ability to come in and own the transradial, or
slender-stenting segment of the market. Transradial interventions
represent the fastest growing segment of the U.S. coronary stent
market and already have a large global following. Our ability to
facilitate the transradial approach and lower procedural costs
by 15% to 20%, given the health economic pressures we all face
today, well, I love that story and agreed to join the company.
MDD: What is the opportunity in owning the transradial
segment for coronary stenting?
Darby: In the U.S. transradial represents 22% to 25% of
stenting procedures, whereas just a few years ago less than 5%
were being done through the wrist. Transradial is used in about
45% of all procedures in Europe, while in Japan it is around
65%. For patients, trans-radial provides greater comfort and
shorter time to ambulation. Patients can get up and walk away
after the procedure with a small compression bandage around
their wrist. With a trans-femoral approach, a closure device or
suturing is commonly used to seal the access site, often requiring
patients to remain in bed for an extended period of time. More
importantly, bleeding complications are significantly less with
the radial approach than the femoral.
We are increasingly seeing health systems train their
physicians on the trans-radial approach because it enhances
patient comfort and saves about $180 per procedure over a
transfemoral procedure. Add to this the opportunity for a same
day discharge versus an overnight stay, which can save about
$1,100 per procedure, and reducing bleeding complications,
which cost about $11,000 per event, and you can quickly see the
potential the transradial approach provides to reduce hospital
costs. Include the Svelte IDS, and hospitals can immediately
extract costs from stenting procedures.
MDD: These sound like cost savings, but what do you mean
by “immediately extract costs from stenting procedures?”
Jack Darby
President/CEO of
Svelte Medical
Darby: By integrating a
balloon and stent on a steerable
guide wire, the Svelte IDS obviates
the need for a steerable wire,
pre- and post-dilatation balloons,
and in some cases, even guiding
catheters. In a standard rapid
exchange stenting intervention
there are 14 steps. Our procedure
takes just 5 steps. We have seen
physicians place our stent literally
within one minute of completing
diagnostic angiography by
delivering the IDS through the
diagnostic catheter. The IDS
requires less back-up support than
traditional systems and has been
used fairly routinely by physicians
through sheathless guides and diagnostic catheters as small as
4 French. Simply put, the IDS requires fewer steps and takes a
lot of equipment out of a procedure. Everything we have done
today demonstrates we are in the 15% to 20% savings range per
procedure. Data from a study in Bern Switzerland showed about
$495 saved per procedure when using our technology.
MDD: If transradial is already expanding, what
differentiates Svelte?
Darby: We have a very good product in terms of the safety and
efficacy. Our first-in-man as well as randomized, controlled clinical
trial data are at least equivalent, if not better, than everyone else.
But having the world’s lowest profile stent system, and ability
to facilitate the trans-radial approach while reducing ancillary
product use, uniquely positions us to change the discussion
from safety and efficacy, where stent providers are essentially
equivalent, to saving money, reducing procedure time and
improving lab turnaround. The Svelte IDS improves interventions
through the wrist, which enhances patient comfort, simplifies the
treatment of complex lesions while reducing procedure times,
which benefits physicians, and extracts hard and soft costs from
stenting procedures, which continues to be a priority for hospitals
and payers. Value is added to all parties involved in coronary stent
procedures, and no other stent technology does this.
MDD: What is your timeline for moving the company
forward?
Darby: We have submitted the IDS technology for CE mark
certification and expect to get that the summer of 2015. In
parallel we are working with FDA and Japan’s PMDA to have
approval to conduct pivotal clinical studies in those countries
in 2016. Going into Europe, our priority is to further validate
our technology and compile large-scale data on the economic
benefits of our technology through robust post-market studies.
With our initial launch in Europe and approvals to conduct clinical
studies in the U.S. and Japan in-hand, we will consider strategic
acquisition or an IPO, pursuing whichever provides the best valuation
of our company and reasonable return to our stakeholders. //

Latin America
in the city of Santos Michelena in the state of Aragua.
“The republic invests to bring [these products] from abroad.
We have the dollars [to bring this]. And we have seized [these
medical supplies]. They had them unlawfully stored, hoarded, so
a vacuum effect could be created [in the market]. . . . The people
who are liable for this are being sought by our security forces,”
said Maduro during his one and a half hour speech after the raid.
“The insatiable bourgeoisie and now this oligarchic fraction
of smugglers, plunder the people. They believe there is no law
for them, and of course there is one and they will pay. All of their
assets have been confiscated and all of their bank accounts have
been frozen,” Maduro said.
“We’ve granted the dollars so there can be a perfect supply
of all what´s needed and what the republic does not produce,”
he said. “Will they argue now that they are politically repressed
and go the United Nations?”
The raid and the president’s incendiary speech surprised the
Venezuelan medical device industry.
Two device distributors were directly affected by the
government’s actions to confiscate their holdings. The two
companies, Suministros Médicos Jayor (Caracas, Venezuela)
and Suplidora Hospimed 2004 (Caracas, Venezuela), are both
affiliated with the Venezuelan Association of Distributors of
Medical, Odontological and Lab Devices (Avedem; Caracas,
Venezuela).
The shortage of medical devices and supplies in Venezuela
has, over the past year, grown dire. Industry stakeholders say
surgical procedures have had to be put on hold as a result of
the shortage. At the heart of the problem is a lack of foreign
currency, which the government controls. Without access to
foreign currency, Venezuelan distributors cannot pay for imports
of fresh supplies. The country’s combined debt in the space
now tops $245 million and most multinationals have stopped
supplying Venezuelan distributors. (Medical Device Daily March
10, 2014; June 2, 2014; Aug 19, 2014)
“If [the government] finds itself beset, because everyone is
complaining of a shortage in medical supplies, they go and chase
a scapegoat to make it look like the government has granted the
dollars and that [everything is fine on the government side],”
said Antonio Orlando, president of Avedem in a phone interview
with Medical Device Daily.
“Suministros Médicos Jayor is a 25-year-old company and
Suplidora Hospimed 2004 is four years old,” said Orlando.
Hospimed is the main supplier of saline solution in the
country. its owner is Jacob Serfati Benzadon. It was his father
who was in charge of the inventory at the Aragua warehouses
“but he had a heart attack four weeks ago and he rushed to a
hospital in Miami. And while he is abroad, [the government] did
what it did,” said Orlando. “The state has to do the legal controls
and inspections, but the right to a legitimate defense must be
guaranteed.”
“[These entrepreneurs] are serious businessmen as far as
we know, they don’t have the need of get in trouble by hoarding
supplies and devices,” he said.
The government said it seized as many as 100 million items
from a 9,000 square meter warehouse during the raid last week
in Santos Michelena.
“When the government talks about what was found in those
warehouses, they say that with all that stock, Aragua could be
supplied for a year or Venezuela for six months,” said Orlando,
who is skeptical about the figures released by the government.
“[The government says that] there were 17 million syringes
seized, but Venezuela consumes more than 300 million syringes
per year. They manipulate the figures for the media, to make
ordinary people believe that it was a giant operation. Everything
is manipulated,” he said.
Since August, the Venezuelan government has been dealing
with various device distributors in the country but none of them
have been able to access the foreign currency they need to pay
off international suppliers.
“They staged a show to feature that they were paying and
one of the companies that received a partial payment actually
was Suministros Médicos Jayor, which had an international
overdue debt of about $20 million. Now their debt is about $4
million to $6 million,” he said.
Representatives from the sector met with Alejandro Fleming,
president of Cencoex (the office of international commerce that
releases foreign currency), who assured them that all their debts
would be covered by the end of this year. However, members of
the sector who attended the meeting said that Fleming remarked
that the priority of Cencoex is to meet the demand for Christmas
goods and supplies.
Meanwhile, Serfati Benzadon, who is allegedly in the U.S.,
faces up to 10 years in prison if he returns to Venezuela or is
arrested by Interpol, said Pedro Viloria, lawyer and partner at
Viloria Consultores in a phone interview from Caracas.
“The government of Venezuela has taken the path of price
caps and it created the Superintendency of Fair Prices with a
huge quantity of prosecutors and inspectors, to control some
prices in the market. [The regulation] mandates a limit of 30
percent of revenue,” Viloria added.
Venezuela´s government will introduce a reform to make
the punishment tougher for hoarders and profiteers.
“There will be some kind of parallelism with the anti
narcotics law,” said Viloria. It is expected that the reform will
increase the punishment for hoarders to up to 14 years in prison.
To date, there are no red notices posted in Interpol’s website
seeking the arrest of Serfati Benzadon or other Venezuelan
medical device distributors.
Nancy Pérez, Minister of Health of Venezuela announced
on October 27 that all the supplies seized, including more than
5,000 wheelchairs would be distributed through the country´s
public health system. //

Beltway
outpatient prospective payment schedule (OPPS) on Halloween.
Congress had weighed in on the matter of tomosynthesis via a
Sept. 29 letter to CMS urging the agency to create new codes to
cover the additional cost of tomosynthesis when added to full
field digital mammography (FFDM) versus FFDM alone (Medical
Device Daily, Oct. 31, 2014).
Among the points made by the signers of the letter, all of
which were Democrats, was that a paper appearing recently
in the Journal of the American Medical Association had claimed
that tomosynthesis can shave $10,000 off the cost of screening
for every 1,000 screened women, an article that enjoyed
considerable esteem given that one of the authors was Etta
Pisano of the Medical University of South Carolina (Charleston,
South Carolina). Pisano is one of the best known experts in the
field and was one of those who argued for the reclassification of
FFDM systems into class II during an FDA hearing in which she
advanced a similar argument for tomosynthesis (MDD, May 25,
2006).
CMS explains in the MPFS final that it had provided an add-on
code to the common procedural terminology (CPT) coding
system for tomosynthesis, which the agency said is “consistent
with the FDA requiring a 2-D mammography when tomosynthesis
is used for screening purposes.” The final rule notes that the new
CTP code, 77063, would be valued on an interim basis pending
a set of recommendations from the relative value update
committee (RUC) on other mammography codes. CMS said it
had assigned CPT 77063 an interim final work relative value of
0.60 “as recommended by the RUC.”
The American College of Radiology (ACR; Reston, Virginia)
published an Oct. 31 brief on the OPPS final to its members,
affirming that the agency has assigned a 0.6 physician
work relative value unit (RVU) to both the new screening
tomosynthesis CPT code and a new add-on code (G-2079) “to
be used with the existing digital diagnostic mammography G
codes to reflect the extra work of tomosynthesis when provided
with digital mammography.” ACR said CMS will continue
the practice of paying separate rates for digital and film
mammography as well.
Hologic published an Oct. 31 statement noting that the
additional codes for tomosynthesis for breast cancer will allow
providers in the U.S. to file reimbursement claims specific to
screening and diagnostic 3-D mammography,” but also that the
news “creates a pathway for private insurers to explore broader
coverage and payment options.”
On the subject of practice expense inputs for stereotactic
radiosurgery (SRS), CMS noted that it had “summarized
comments received about whether CPT codes 77372 and 77373
would accurately reflect the resources used in furnishing the
typical SRS delivery” – assuming there were no differences in
coding between robotic and non-robotic delivery methods –
as part of the CY 2014 final rule. The agency noted that it had
considered deleting two contractor-priced G codes (0339 and
0340) “in future rulemaking,” but noted that most commenters
expressed the view that the CPT codes “accurately described
both services” and that the RUC was of the view that the practice
expense inputs “accurately accounted for the resource costs”
invoked in providing the referenced services.
CMS concluded that it lacked sufficient data to justify
deleting the G codes and will instead work with stakeholders to
“identify an alternate approach” and take the matter up in future
rulemaking.
The agency remarked that for calendar 2014, it had
established relative value units for three “newly created”
CPT codes (37236, 37237, and 37238) as interim final values,
but that it had not agreed with the RUC recommendation for
the relative value for 37239, which takes up the placement of
intravascular stents in additional veins. CMS argued that the
work for placement of an additional stent in a vein “should
bear the same relationship to the work of placing an initial
stent in the vein as the placement of an additional stent in
an artery to the placement of the initial stent in an artery.”
CMS held to this position in the final rule despite some
comment to the contrary, including one recommendation
that the agency refer the matter to refinement panel review.
The agency declined, stating that the situation did not
qualify for such a review.
CMS affirmed the proposed schedule’s discussion of
payment for anesthesia services provided in conjunction with
certain colorectal cancer screening tests to “include anesthesia
that is separately furnished.” The agency remarked that the
change would “further reduce our beneficiaries’ cost-sharing
obligations under Part B” thanks to the U.S. Public Services
Task Force recommendation on CRC screening, which under the
Affordable Care Act eliminates co-pays.
In a fact sheet accompanying the release of the
MPFS final rule, CMS reported a change to the hardship
exceptions for the Medicare electronic health record (EHR)
incentive program, said to consist of an interim final rule
with a request for public comment. The fact sheet indicates
that the interim rule “provisionally adopts changes to
the regulatory language about hardship exceptions from
the Medicare payment adjustment” included in the EHR
incentive programs.
The agency said that it had reopened the submission
period for hardship exception applications in October to
avoid loss of payment for not demonstrating meaningful use
objectives. CMS explained that eligible parties that have
never met meaningful use standards up to now may reapply
if they had been unable to fully roll out the 2014 edition of
the Certified Electronic Health Record Technology (CEHRT)
standard “due to delays in 2014 Edition CEHRT availability,
and could not attest by the early attestation deadline for
new participants.” //

PRODUCT BRIEFS
• Covidien (Dublin, Ireland) reported FDA clearance for the
HawkOne directional atherectomy system. The latest addition
to Covidien’s directional atherectomy portfolio, the HawkOne
system is designed to provide physicians with an enhanced
cutting mechanism to more effectively treat the widest variety
of plaque in patients with peripheral arterial disease (PAD).
Covidien said its directional atherectomy portfolio includes the
TurboHawk and SilverHawk systems and is backed by more than
15 peer-reviewed studies.
• Intact Vascular (Wayne, Pennsylvania), a medical device
company and developer of products for minimally invasive
peripheral vascular procedures, reported its completion of
the TOBA-BTK study, Tack Optimized Balloon Angioplasty –
Below the Knee Study. This multi-center pilot study focused on
gathering data supporting the safety and performance of the
Tack Endovascular System in subjects with critical limb ischemia
(CLI) due to vascular disease below the knee. Thirty-five subjects
were enrolled in this study which targeted diseased tibial vessels
for treatment. CLI is an advanced stage of peripheral artery
disease in which patients suffer from inadequate blood flow
to the lower leg and foot. The Tack Endovascular System has
been designed to leave minimal foreign material in the artery,
to apply only the minimum outward force required to repair
tissue tears within the lumen, and to allow spot treatment only
where needed. The system is composed of a delivery catheter
containing three self-expanding nitinol tacks.
• SeraCare Life Sciences (Milford, Massachusetts), a
provider of biological materials that help optimize diagnostic
performance, reliability and repeatability across the IVD lifecycle,
reported seven new AccuSpan molecular linearity panels for
the detection of Adenovirus (ADV), Varicella Zoster Virus (VZV),
JC Virus (JCV), Herpes Simplex Virus 1 (HSV1), Herpes Simplex
Virus 2 (HSV2), Epstein Barr Virus (EBV), and BK Virus (BKV).
These new linearity panels from SeraCare help assay developers
thoroughly challenge their transplant assays from extraction
phase through amplification. Each panel consists of four
members: one negative, one low positive, one medium positive,
and one high positive sample. These panels are provided in a
ready-to-go single-use format with target concentrations that
cover the dynamic range of most molecular assays and are
consistent within each lot and across batches. SeraCare partners
with diagnostics researchers, IVD manufacturers and clinical
laboratories to shape the future of precision medicine.
• Stratasys (Minneapolis), a provider of 3-D printing
and additive manufacturing solutions, introduced the Fortus
450mc and Fortus 380mc 3-D production systems, designed to
provide improved reliability, speed and accessibility. Using FDM
technology, both 3-D production systems are designed to provide
high-quality engineering grade parts that can be used to reduce
the time to bring a product to market, create jigs and fixtures for
manufacturing, as well as produce low volume end-use parts.
The Fortus 450mc can make parts up to 15% faster than its
predecessor, Stratasys said. It has a build envelope of 16 in. x
14 in. x 16 in. (406mm x 355mm x 406mm), and it can produce
layer resolutions ranging from 0.005 in. to 0.013 in. (0.127mm
to 0.330mm). The Fortus 450mc has capacity for two model
material and two support material canisters, and the usage level
can be monitored using the touch screen. Industries including
aerospace, government, military and medical, requiring
complex functional prototypes, production aides and end-use
parts in specialized materials may benefit by using the Fortus
450mc. The Fortus 380mc has the same advanced features as
the Fortus 450mc including even temperature distribution in the
build chamber and a digital touch screen. On average, the 3-D
printer can build parts up to 20% faster with a build envelope of
14 in. x 12 in. x 12 in. (355mm x 305mm x 305mm) with the same
layer resolutions as the Fortus 450mc.
• VisionCare Ophthalmic Technologies (Saratoga,
California), a maker of advanced visual prosthetic devices for
the treatment of age-related macular degeneration (AMD),
reported the Centers for Medicare and Medicaid Services (CMS)
will reimburse the Implantable Miniature Telescope under a
revised ambulatory payment classification designation, APC
0351, Level V Intraocular Procedures. The report was included
as part of CMS’ CY 2015 Hospital Outpatient Prospective
Payment System (OPPS) and Ambulatory Surgery Center (ASC)
Payment System final rule. The outpatient surgical procedure
for telescope implantation has been restricted to hospitals
until now due to current reimbursement rules, despite the fact
that approximately 80% of ophthalmic surgical procedures
are performed in local ASCs. The CMS ruling provides the
mechanisms needed for broad ASC adoption of the therapy,
which will significantly improve patient access and bolster
ophthalmologist and healthcare provider efficiency. When the
new designation for APC 0351 code takes effect on January 1,
2015, reimbursement payment levels will increase overall and
ASC payment levels will be comparable to those paid to hospital
outpatient departments. VisionCare Ophthalmic Technologies
VisionCare’s Implantable Miniature Telescope was invented by
company founders Yossi Gross and Isaac Lipshitz.
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WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 1 OF 2
Keeping you up to date on recent developments in oncology
ONCOLOGY EXTRA
Continues on next page
New approach could kill tumor cells
in the brain better and avoid side effects
Every year, about 100,000 Americans are diagnosed with
brain tumors that have spread from elsewhere in the body. These
tumors, known as metastases, are usually treated with surgery
followed by chemotherapy, but the cancer often returns.
A new study from MIT, Brigham and Women’s Hospital, and
Johns Hopkins University suggests that delivering chemotherapy
directly into the brain cavity may offer a better way to treat tumors
that have metastasized to the brain (Intracranial microcapsule
chemotherapy delivery for the localized treatment of rodent
metastatic breast adenocarcinoma in the brain, PNAS, (www.
pnas.org/cgi/doi/10.1073/pnas.1313420110). Testing their new
approach in mice, the researchers found that the chemotherapy
drug temozolomide (TMZ) was more effective when delivered
via tiny capsules implanted inside the skull. This suggests that
a similar approach might be more effective in human patients,
says Michael Cima, the David H. Koch Professor of Engineering
at MIT and a senior author of the study, which appears this
week in the Proceedings of the National Academy of Sciences.
“Metastatic disease should be sensitive to chemotherapy, but
systemic chemotherapy has not proven effective because it’s not
getting to the brain at a high enough dose for a long enough
period of time,” says Cima, who is also a member of MIT’s Koch
Institute for Integrative Cancer Research. “We’re showing we get
much higher degrees of tumor cell death when we deliver the
drug locally.”
Targeted delivery: The researchers delivered chemotherapy
drugs via implantable microcapsules made of a biocompatible
material called liquid crystal polymer. The capsules are small
cylinders with a 1.5-milliliter drug capacity; the drug diffuses out
through a small hole. The researchers tested 2 chemotherapy
agents: TMZ, which is a first-line treatment for brain metastasis
and gliomas, and doxorubicin, a common treatment for breast
cancer, which often metastasizes to the brain.
Zone of influence: Working with mice implanted with
tumors similar to human brain metastases, the researchers
found that TMZ delivered directly to the brain prolonged survival
by several days compared with TMZ administered by injection.
They also found higher rates of apoptosis, or programmed cell
death, in tumor cells near the capsules.
The Global Incidence and Prevalence Report from
the Incidence and Prevalence Database (IPD), states that
worldwide, 800,000 patients are on chemotherapy. In England,
the number of patients receiving chemotherapy each year is
increasing. An estimated 65,000 chemotherapy programs (a
planned period of repeated cycles of treatment) are delivered
annually. In the US, with over 25 million doses administered
annually, oral chemotherapy is an expanding and potentially
hazardous treatment for cancer patients. In a 2006 survey of
US cancer centers, only 1 in 4 centers had standard prescribing
safeguards in place for oral chemotherapies, and fewer than 1 in
5 had measures to ensure safe administration and monitoring.
Evidence behind complementary therapies is mixed
Cancer is frightening enough to prompt a lot of speculation
as to what might cure or treat it, a parade of offerings that
probably did not start with Laetrile. A recent statement by
Columbia University (New York) takes up the matter of these
alternative therapies, stating that some score well, while
others fall short. As might be expected, “meditation, yoga,
and relaxation with imagery were found to have the strongest
evidence supporting their use” compared to some treatments,
earning a grade of A, including for routine use to aid in dealing
with anxiety and other mood disorders often encountered by
breast cancer patients. Acupuncture scored a grade of B for
controlling chemotherapy-induced nausea and vomiting and
can be recommended to most patients. On the other hand, more
than two dozen other interventions, a list said to include “some
natural products and acupuncture for other conditions,” offered
slimmer bases of evidence “due to either small study sizes or
conflicting study results, and received a C grade,” the statement
notes. Among the modern abject failures is acetyl-l-carnitine,
marketed to prevent chemotherapy-related neuropathy, but
which actually increased risk for the condition.
French team picks up early lung cancer cells with ISET
Researchers at the French Institute of Health and Medical
Research (Institut national de la santé et de la recherche
médicale, or Inserm), have made headway in the effort to provide
early detection of lung cancer with ISET filtration-enrichment
techniques, a development that could beat CT scanning to a
definitive diagnosis by “several months, and in some cases
several years,” according to an Inserm statement. The statement
explains that the study tracked 245 people without cancer,
including 168 deemed at risk due to COPD, and the blood test
picked up circulating cancer cells in five patients (3%) despite
that imaging did not show any nodules in the lungs. In these
five patients, a nodule became detectable between one and
four years after detection of circulating cancer cells by the ISET
filtration method, and they each immediately underwent surgery
with biopsy of the removed lesion confirming the diagnosis.
A one-year check-up showed no sign of recurrence in the five
patients, and no nodules were detected during monitoring

WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 2 OF 2
ONCOLOGY EXTRA
Continued from previous page
of subjects who did not have circulating cancer cells, while
no cancer cells were detected in the bloodstream of “control”
subjects without COPD. This research appears in Plos One under
the title “Sentinel Circulating Tumor Cells Allow Early Diagnosis
of Lung Cancer in Patients with Chronic Obstructive Pulmonary
Disease.”
Louisiana State University snares
award for breast cancer support
The Louisiana State University (LSU; Baton Rouge) School of
Public Health has been awarded a $2.2 million grant to increase
the availability of health information and support services for
young breast cancer survivors in the American Gulf South,
according to a Nov. 3 LSU statement. The Centers for Disease
Control and Prevention made the award, which will be paid out
over five years, to support the development and implementation
of strategic and integrated multi-media health education and
awareness campaigns to address the health information needs of
these patients. LSU will use the money to bring together a three-state
coalition from organizations in Louisiana, Mississippi, and
Alabama that will go by the name of the Gulf States Young Breast
Cancer Survivors Network. LSU’s Donna Williams, will serve as
the principal investigator in the program, which is tasked with
developing and disseminating “pertinent and culturally sensitive
health information via social media.” Messages will address
family history and genetic risks, psychosocial health and support,
reproductive health and fertility, family support, health monitoring
and evidence-based preventive lifestyle behaviors like maintaining
a healthy weight, reducing tobacco use and excessive alcohol use.
NSAIDs fight cancer by inducing apoptosis
Aspirin has seemed for decades like a mystery drug, but a
recent statement by the University of Pittsburgh (Pittsburgh)
School of the Health Sciences explains how salicylic acid and
other non-steroidals influence colorectal cancer (CRC). The
statement notes that a recent study appearing in the Proceedings
of the National Academy of Sciences consisting of experiments
in animal models and tumor samples from patients who had
taken NSAIDs and those who hadn’t suggests that NSAIDs
activate the “death receptor pathway.” This pathway is credited
with selectively triggering a suicide program in intestinal stem
cells that have a mutation in the APC gene that renders the cells
dysfunctional. Healthy cells lack the mutation, so NSAIDs exert
no effect on those cells. In that manner, the drugs instigate the
early auto-destruction of cells that could lead to pre-cancerous
polyps and tumors. Senior investigator Lin Zhang, said the study
“identifies a biochemical mechanism that could explain how this
preventive effect occurs,” adding, “these findings could help us
design new drugs to prevent colorectal cancer, which is the third
leading cause of cancer-related deaths in the country.”
Eribulin shown to extend survival in breast cancer
Makers of companion diagnostics may have more reason
to invest in a test associated with eribulin (or Halaven, made by
Eisai of Tokyo) thanks to a recent statement by Cancer Research
UK (London). The statement explains that this drug, which was
developed from chemicals found in sea sponges, may offer women
with advanced triple negative breast cancer an average of five extra
months of life. Researchers looked at two major clinical trials of
more than 1,800 women with breast cancer that had started to
metastasize, and the phase III trials compared the survival of women
treated with eribulin to those given standard treatment. The two
studies showed an overall improvement in survival of more than
two months for women treated with eribulin. The most significant
improvement was seen in women with the advanced triple negative
form of breast cancer, where there are limited treatment options;
these women’s survival improved by nearly five months. There was
also a survival boost of more than two months for women with the
HER2 negative form of breast cancer.
East, West Coast institutes win genomic pilot contract
The Broad Institute of MIT and Harvard (Boston) and two
institutions in the California state university system have won
an award from the National Cancer Institute Cancer Genomics
Cloud Pilot that will go toward the building of a system that will
enable large-scale analysis of The Cancer Genome Atlas (TCGA)
and other datasets by co-locating the data and the required
computing resources in one cloud environment. This co-location
will enable researchers across institutions to bring their analytical
tools and methods to use on data in an efficient, cost-effective
manner, thereby promoting democratization and collaboration
across the cancer genomics community, the statement explains.
Large-scale sequencing efforts are helping researchers understand
the genetic changes that lead to cancer and have led to the
development of several successful, targeted chemotherapies.
These developments show that identifying mutations that drive
cancer can translate into therapeutics. However, three main
challenges remain: first, processing massive sequence datasets
requires costly computational infrastructures for which few groups
have the resources; those that do have the resources often end up
duplicating each others’ engineering and analysis efforts. Second,
data generation is outpacing the development of tools and methods
that can be used on such large datasets: already, petabytes of data
exist, and exabytes are on the near horizon. Finally, data is being
collected and stored in silos, minimizing the potential for synergy,
data sharing and integrated analysis. Gad Getz, of the Broad
Institute said the pilot “will allow the cancer research community
to collaborate in a way that has not been possible before. We’ll now
be able to share data and tools and jointly learn from the totality
of cancer genomics data. Our cloud system will democratize
access to computational tools for non-experts as well as empower
developers with a platform for creating the next generation of
analytical methods.”

Caracas Asked Interpol to iusseu red notice against allaged med-tech "hoarders"

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