Mdd091013

TUESDAY, SEPTEMBER 10, 2013 VOL. 17, NO. 174 PAGE 1 OF 10
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INSIDE:
Don’t miss today’s MDD Extra: Cardiology
Regional innovation review
Metro Denver is home to a diverse
range of device companies
By JEFFREY BERG, PhD
Medical Device Daily Contributing Writer
Technology transfer is a viable component of the
UniversityofColoradoresearchenterprise,andanimportant
contributor to Colorado’s innovation economy. Rick Silva,
PhD, Director of the University of Colorado Technology
Transfer Office (Aurora), said that the university’s
medical school (the only one in the state of Colorado) is
ranked among the top 10 medical schools in the country
with regard to the number of startup companies that have
been spun out. There have been over 90 spinoff companies
in the last 10 years and more than 80% of startups in the
past 15 years have been sold or are still operating. concerns.
Silva also noted that the university has been the recipient
of $420 million in research awards. He shared with Medical
Innovative Braintech conference
creating cross-discipline thought
By JONATHAN GOLDSTEIN
Medical Device Daily Israel Editor
There is something different about the newly-formed
Israel Brain Technology (IBT) organization, with its inaugural
BrainTech conference planned for mid-October in Tel Aviv.
The group was the brainchild of Israel’s President, Shimon
Peres. In May 2011, on the podium of the large Israel Biomed
conference, Peres expressed his desire to see Israel grow in
this virgin landscape of brain technologies. “Unravelling the
secrets of this complex system, he said, is an area where we
in Israel should excel.” Since then, his dream has started to
be realized by one of Israel’s most successful entrepreneurs,
Dr. Rafi Gidron, who for years had felt that the brain was
‘the next frontier’, and that he should work towards a better
understanding and definition of the neural system and its
disorders. With the president’s desire, and Gidron’s drive,
Report from Europe
Tenaxis gets CE mark for more
indications of ArterX sealant
A Medical Device Daily Staff Report
Tenaxis Medical (Mountain View, California) said it
has received approval to expand its CE mark indications
for ArterX Surgical Sealant. The ArterX Surgical Sealant is
designed to be applied directly over suture or staple line
to achieve hemostasis during surgery to seal the area to
stop and prevent leaks. The intended use for the product
has now been expanded for use in cardiac, vascular and
soft tissue reconstructions. This includes a wide variety of
surgical procedures including the vasculature and major
organs that involve bleeding or leakage.
Approved CE Mark indications and usage specified in
the new product labeling include:
• Cardiac Reconstructions: aortic root replacement,
Washington roundup
OIG; Medicaid DME prices
higher than Medicare prices
By MARK McCARTY
Medical Device Daily Washington Editor
A recent government report compared prices paid
for durable medical equipment under Medicaid to those
paid under the Medicare competitive bidding program,
and concluded that the federal government and the state
of Texas could have saved government $2 million had
Medicaid DME prices matched Medicare bidding prices
in the Dallas-Forth Worth area. However, the report came
up short of recommending Medicare bidding rates for
Medicaid, and one trade association told Medical Device
Daily that the idea has picked up little traction on Capitol
Hill over the past four years despite repeated proposal by
the White House.
See Braintech, Page 6
See Europe, Page 8 See Washington, Page 9
See Denver, Page 7
CEQUR CLOSES $27 MILLION SERIES B FUNDING ROUND . . . . . . . . . 2
THERAGENICS ‘GO SHOP’ EXPIRES, JUNIPER TO CLOSE IN 4Q . . . . . . . 3

TUESDAY, SEPTEMBER 10, 2013 MEDICAL DEVICE DAILY™
PAGE 2 OF 10
Coming Wednesday
in MDD Perspectives
Asia and Europe: med-tech markets in churn
Developments in the world of medical devices vary by
region, but a few recent stories from the pages of Medical
Device Daily give a good sense of just how turbulent the
global market is. To read more, see tomorrow’s edition
of MDD Perspectives, an op-ed e-zine that provides fresh
commentary from the MDD Perspectives blog, http://
mdd.blogs.medicaldevicedaily.com. Plus, you’ll have
access to free articles from Medical Device Daily. If you
don’t already receive this complimentary e-zine, go to
medicaldevicedaily.com to opt in.
Financings roundup
CeQur closes $27 million
Series B funding round
See Financings, Page 3
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CeQur (Horw, Switzerland) has closed a $27 million
dollar Series B financing. The financing was led by two
new private investors with the participation of all current
shareholders, and will support manufacturing scale up
for the CeQur PaQ simple insulin delivery device, which
received CE mark approval in November 2012.
Proceeds from this financing round will also be used
to fund activities related to U.S. regulatory approval. In a
study involving people with Type 2 diabetes completed last
year, PaQ safely and effectively delivered patients’ insulin
requirements with a high level of patient satisfaction and
acceptance, and demonstrated ability to reduce known
barriers to insulin therapy and a trend towards improving
patients’ glycemic control.
“This financing is a reflection of the tremendous
progress we’ve made with PaQ in the past two years, the
strength of our clinical data, and a broad understanding of
the value this transformative device will bring to people with
Type 2 diabetes,” said Eric Milledge, chairman of CeQur. “We
are excited to expand our manufacturing and commercial
capabilities so that we can begin to make this technology
broadly available to those in need.”
PaQ is a discreet, wearable device that provides three
days of consistent, basal insulin delivery along with easy,
on-demand bolus insulin. The small device comprises a
disposable insulin infuser reservoir attached to a reusable
insulin monitor.
“We’vedevelopedasimpleandaffordableinsulindelivery
solution for people with Type 2 diabetes that can free them
from the burden of multiple daily injections so that they can
more comfortably and consistently maintain target glycemic
values,” said James Peterson, founder and CEO, CeQur.
CeQur makes insulin delivery devices that make it
easier for people living with Type 2 diabetes to adhere to
therapy and stay in control of their disease.
In other financings news:
• Sapheon (Morrisville, North Carolina) has raised $19.8
million in its Series B Preferred equity offering from current
and new accredited investors. The funding will support
Sapheon’s U.S. pivotal study through final submission to
the FDA of the PMA application for the VenaSeal Sapheon
Closure System.
In addition, Sapheon reported full enrollment of 242
patients in the U.S. pivotal study of the VenaSeal Sapheon
Closure System. VenaSeal – a minimally invasive, single
use kit for the treatment of venous reflux (varicose veins)
by means of a tumescent-free, transcatheter delivery of
Sapheon’s proprietary medical adhesive to the diseased

PAGE 3 OF 10
Deals roundup
Theragenics ‘go shop’ expires,
Juniper merger to close in 4Q
Theragenics (Buford, Georgia), a device company
serving the surgical products and prostate cancer treatment
markets, reported the expiration of the 35-day ‘go-shop’
period of the terms of its previously disclosed merger
agreement providing for a newly formed affiliate of Juniper
Investment Company to acquire all of the outstanding
common stock of the company for $2.20 a share in cash.
The company reported last month, after several months
of talk with Juniper, that it had struck a merger agreement
with Juniper, valuing Theragenics at $68.3 million (Medical
Device Daily, Aug. 6, 2013). At that time, the company’s board
had already unanimously approved the merger agreement.
Theragenics’ President/CEO Christine Jacobs said
at that time that the transaction presents a “significant
premium” over the company’s trading prices prior to the
announcement of discussions with Juniper. Jacobs plans
to retire from Theragenics upon closing of the merger, the
company noted last month.
During the go-shop period, the company was allowed
to initiate, solicit and encourage acquisition proposals
from third parties. Theragenics says its financial advisor,
VRA Partners, contacted 15 parties, including nine financial
parties and six strategic parties, to solicit interest for
potential alternative transactions during the go-shop period
but none of the parties contacted submitted a proposal and
no other party has made an unsolicited proposal.
The company said it will hold a special meeting of
stockholders on Oct. 17 to consider and vote on proposals
to adopt the merger agreement, to cast an advisory vote on
merger-related compensation, and if necessary to approve
any adjournment or postponement of the special meeting to
permit further solicitation of proxies if there are insufficient
votes at the time of the special meeting to adopt the merger
agreement.
Theragenics said it has set the close of business on Sept.
16 as the record date for stockholders of record entitled to
vote at the special meeting. The merger is expected to be
completed during the fourth quarter, subject to stockholder
approval and satisfaction of the closing conditions set forth
in the merger agreement.
In other dealmaking activity, Incumaker (Atlanta) said
it has completed the acquisition of CryoMist I and CryoMist
II with a third acquisition of CryoMist III planned to close
by early 2014. CryoMist (Winter Garden, Florida) is on the
forefront of cryogenic therapy which is the general use of
low temperatures in medical therapy, Incumaker said.
CryoMist is designed to stimulate the body’s natural
healing abilities with extreme cold to induce responses on
three levels, the circulatory system, the energy meridians,
and the nervous system. According to Incumaker, this
elicits a “powerful, positive and holistic response.” Financial
details were not disclosed.
Using a nitrogen fueled chamber to lower the
temperature surrounding the client, the CryoMist apparatus
is focusing on the treatment of pain and inflammation from
sports injuries, fibromyalgia, rheumatoid arthritis, multiple
sclerosis and skin conditions like psoriasis and dermatitis.
CryoMist treatments are administered individually for
up to three minutes. Due to the extreme cold, the brain
stimulates the body’s organ regulatory functions resulting
in energy increase, cell rejuvenation, immune system boost,
and overall system self-healing. Studies have shown that
following each treatment increased metabolism burns from
500to800caloriesoverthenextseveralhours.Additionally,
anti-aging benefits due to the production of collagen have
been shown in many cases, according to the company. ■
great saphenous vein – is currently under investigation
in a 1:1 randomized pivotal study at 10 U.S. clinical sites to
determine its safety and effectiveness compared to radio
frequency thermal ablation.
Don Crawford, Sapheon’s president/CEO, said, “We are
fortunate to have attracted knowledgeable, sophisticated
investors who recognize the potential for VenaSeal to
become the future standard of care for a large and growing
U.S. patient population of venous reflux sufferers. We are
also fortunate to have successfully recruited leading U.S.
physicians with large, active vein practices to participate as
clinical investigators in our pivotal study.”
Sapheon makes technologies for the treatment of
vascular disease.
• Intelomed (Pittsburgh), a maker of noninvasive
medical devices and technology for monitoring
cardiovascular stability, has secured $4 million in funding
from new and existing shareholders through the sale of
its Series A-1 Common Preferred stock. The funding will be
used to launch sales efforts and pursue additional clinical
validations for newly implemented product features.
“At Intelomed, we believe we have a great opportunity
to introduce meaningful improvement to the quality of care
in a variety of areas within healthcare. Over the past two
years, we have made great progress and look forward to not
only continuing that momentum but accelerating it,” said
Frank Amoruso, president/CEO of Intelomed. “We are very
fortunate to have a strong network of investors that believe
in our vision and approach. While our investor network
includes investors local to Pittsburgh, the majority of our
funding was received from the New York and California area.”
Intelomed’s flagship product, CVInsight, will be
introduced to the Hemodialysis industry and the Long-
term Care and Nursing Home industry over the next several
months. ■
Financings
Continued from Page 2

PAGE 4 OF 10
Agreements/contracts
Unilife signs long-term
supply deal with Sanofi
Unilife (York, Pennsylvania), a maker of injectable drug
delivery systems, has signed a long-term supply contract
with Sanofi (Paris).
Unilife has agreed to supply Sanofi with the Unifill
Finesse, a customized device from its Unifill platform of
prefilled syringes with automatic, needle retraction, for use
with the anti-thrombotic therapy Enoxaparin Sodium sold
under the brand names Lovenox and Clexane. The contract
period can extend up to 2024.
Unilife has granted Sanofi the exclusive use of the Unifill
Finesse with anti-thrombotic drugs during the contract
period. Following a four-year ramp-up period after market
entry, exclusivity will be maintained, subject to Sanofi
purchasing a minimum of 150 million units of the Unifill
Finesse or other Unifill syringes per year.
Unilife can supply its Unifill syringes, including the Unifill
Finesse, to additional customers in all other therapeutic
classes outside of anti-thrombotics.
In addition to future revenue from the sale of Unifill
Finesse syringes, Unilife may receive up to $15 million from
Sanofi in milestones based payments with $5 million of
these payments expected in 2013.
This supply contract replaces and supersedes all
other agreements previously signed between both parties
regarding the Unifill syringe platform.
“Our Unifill syringes set a new standard for the delivery
of all prefilled biologics, drugs and vaccines. Like other
game-changing products in our broad device portfolio, the
distinctive visual, safety and functional benefits of Unifill
can be leveraged by pharmaceutical customers to enhance
and differentiate their injectable therapies. We thank the
Sanofi Industrial organization for their innovative vision and
their support, and look forward to a long-term partnership,”
said Alan Shortall, CEO of Unilife.
In other agreements/contracts news, SurgiCount
Medical (Irvine, California), the wholly-owned operating
subsidiary of Patient Safety Technologies, has been
awarded an Innovative Technology agreement by Novation
(Irving, Texas), a healthcare supply chain expertise, analytics
and contracting company for the more than 65,000
members of VHA, UHC, Children’s Hospital Association and
Provista. The companies say this agreement recognizes
the innovation and clinical advancements provided by
SurgiCount’s retained sponge prevention solution, the
Safety-Sponge System, and provides the members Novation
serves with special pricing and other pre-negotiated terms.
“By offering a simple solution that eliminates the most
common surgical adverse event, we help users of our
SurgiCount Safety-Sponge System mitigate their liability,
protecttheirreimburserevenues,preservetheirreputations
in the communities they serve and improve their patient
outcomes,” said Scott Pecore, VP National Accounts for
SurgiCount Medical.
According to Brian Stewart, president/CEO of
SurgiCount, “We share Novation’s goals of helping their
members achieve improved outcomes through clinical
and operational excellence and reducing the total cost of
patient care. We are pleased that Novation’s Innovative
Technology process resulted in the recognition of the
economic and safety benefits of the Safety-Sponge System
and look forward to helping Novation members achieve
their quality and cost objectives.”
Patient Safety Technologies makes the Safety-Sponge
System, a solution clinically proven to improve patient
safety and reduce healthcare costs by helping prevent one
of the most common errors in surgery, retained surgical
sponges.
• Physio-Control (Redmond, Washington), a provider
of emergency medical response technologies, and the
PulsePoint Foundation (Pleasanton, California), a
non-profit organization dedicated to providing mobile
technologies to help everyday citizens save lives, said
that the two organizations have entered into a strategic
partnership aimed at improving sudden cardiac arrest (SCA)
survival in communities around the world. The partnership
seeks to meet the growing public safety agency demand for
the PulsePoint CPR/AED mobile phone application and to
expand citizen responder cardiopulmonary resuscitation
(CPR) and public access automated external defibrillator
(AED) networks.
The PulsePoint app alerts CPR-trained citizens by
smartphone of SCA emergencies in their proximity and
provides the location of the nearest public access AEDs.
Deployment of the PulsePoint app can significantly
strengthen the “chain of survival” by improving bystander
response to SCA victims and increasing the chance
that lifesaving steps will be taken prior to the arrival of
emergency medical services professionals.
Throughthepartnership,Physio-Controlwillcollaborate
with the PulsePoint Foundation to expand availability of
PulsePoint to public safety agencies worldwide. Physio-
Control will promote PulsePoint to public safety agencies
through its global sales and service teams and expand on
PulsePoint’s capabilities for system implementation and
support.
The PulsePoint smartphone app is available to the
public free of charge for Apple iOS and Google Android
devices from the Apple App Store and Google Play.
• Humana (Louisville, Kentucky) and Hospital
Corporation of America (HCA; Tampa, Florida)-affiliated
Florida hospitals said they have reached an agreement on a
new two-year provider network contract.
The contract renewal enables Humana Medicare and
See Agreements, Page 10

PAGE 5 OF 10
People in the NewsPeople in the News
• Baxter (Deerfield, Illinois) reported that its board has
elected Todd Young as treasurer and a corporate officer of
the company. Young will report to Baxter’s chief financial
officer, Robert Hombach, succeeding James Saccaro in the
role. Saccaro has assumed a senior leadership role within the
company’s Medical Products commercial organization. In his
previous role, Young served as vice president, international
finance for Baxter. He joined the company in 2001 as
corporate tax counsel, and over the years assumed positions
of increasing responsibility, including vice president of
international tax, assistant treasurer, vice president, finance
for the company’s Asia Pacific region, and vice president,
corporate planning and analysis. Prior to joining Baxter, he
worked as a tax attorney at Sidley & Austin. Baxter develops
products that save and sustain the lives of people with
hemophilia, immune disorders, infectious diseases, kidney
disease, trauma, and other chronic and acute medical
conditions.
• BioDirection (Tucson, Arizona) said Robert Reid has
joined the company as VP, global marketing. Reid previously
had an extensive career with Boston Scientific, holding
multiple executive marketing and program management
positions, most notably having led the formation and launch
of the company’s neurointerventional division. BioDirection
makes point-of-care brain injury screening and monitoring
devices to separate minor head injuries for mild traumatic
head injury.
• DFine (San Jose, California) has named Greg Barrett
as president/CEO. Barrett most recently was chairman,
president/CEO of Barrx Medical. Dfine is dedicated to
relieving pain and improving the quality of life for patients
suffering from vertebral pathologies through minimally
invasive, targeted therapies.
• Digital Angel (Delray Beach, Florida) has named
Caryn Mills as its director of strategic alliances for its unique
device identification business. Mills has more than 15 years
of sales, marketing and customer relations expertise, most
of which comes from the medical device and pharmaceutical
industries, including companies such as Covidien Surgical
Solutions and Schering Plough. Digital Angel, through its
VeriTeQ wholly-owned subsidiary, makes RFID technologies
for implantable medical device identification, and dosimeter
technologies for use in radiation therapy treatment.
• Endo Health Solutions (Malvern, Pennsylvania)
has named Suketu Upadhyay as executive VP/CFO of Endo,
effective Sept. 23. Prior to joining Endo, Upadhyay served as
principalaccountingofficerandinterimchieffinancialofficer
of Becton, Dickinson & Company. Endo Health Solutions
has four distinct business segments that are focused on
branded and generic pharmaceuticals, devices and services,
each providing quality products to our customers while
improving the lives of patients.
• Independent Living Systems (Miami) has named
Lisa Olexy as senior VP of sales and marketing. Olexy
previously was chief development officer at ValueOptions
and VP of business development at Horizon Health.
Independent Living Systems provides long-term care
management, post discharge and nutrition services aimed
at improving the aging experience for millions of America’s
elderly, special needs and dual eligible individuals.
• PatientPoint (Cincinnati) has named Geeta Nayyar,
MD, as the company’s chief medical information officer.
Nayyar was most recently the chief medical information
officer at AT&T, where she provided a clinical perspective
to the AT&T ForHealth strategy and portfolio. PatientPoint
makes patient and physician engagement solutions at the
point of care.
• Staar Surgical (Monrovia, California) has named
Stephen Brown as CFO. Brown joins Staar from Bausch &
Lomb Surgical, where he served as VP, global finance since
2008. Staar Surgical makes implantable lenses and delivery
systems to the eye.
Product BriefsProduct Briefs
• Vision-Sciences (Orangeburg, New York), a
provider of flexible endoscopic products using its sterile
disposable EndoSheath technology, reported positive
results from a three-month evaluation completed in 2012 by
the British Army at Camp Bastion, a deployed field hospital
in Afghanistan. The research evaluated the efficacy and
utility of the company’s flexible bronchoscope with
EndoSheath technology and its rapid, simplified cleaning
routine vs. conventional bronchoscopes, which require
specialized, complicated disinfection processes between
each use. In a deployed environment, bronchoscopy can
play an important role when caring for patients who
have suffered penetrating trauma as they often develop
complications, such as bleeding from the airways, mucus
plugging, and pulmonary infections. The three physicians
who used the scope ten times during the three-month
period of evaluation were all experienced in bronchoscopy,
including two pulmonary and critical care physicians
and one anesthetic trained intensivist. The EndoSheath
technology was used predominantly in patients with high
velocity fragment or bullet wounds to the thorax to clear
blood from the airways. In one instance, this was found to
be life-saving, and in another, it significantly shortened the
length of time for ventilation and allowed early extubation.
The system also demonstrated its utility in performing
percutaneous tracheostomy. Vision-Sciences’ EndoSheath
technology provides a sterile, disposable, microbial
barrier between the bronchoscope and patient, including
a disposable biopsy/suction channel.

PAGE 6 OF 10
Braintech
IBT was formed.
Israel is a perfect place to kick-start this field of brain-
focused technologies. “What Israel has done in biomedical
research,andespeciallyindevices,istodevelopageneration
of out-of-the-box thinking and creativity that enables new
medical initiatives to be kick-started with relative ease,”
said Morry Blumenfeld, founder of Israel-based Meditech
Advisers (Beit Shemesh), and member of the Conference
Steering Committee. “If anyone can dream about unraveling
the brain’s secrets, and helping to solve medical problems
in the brain, this place is one of the best places to dream of
that.”
IBT believes that the world of brain technology —
covering all areas of neurological disease, from Alzheimer’s
to migraine, and from epilepsy to stroke - needs additional
funding, and global collaboration. Much like many
scientific/clinical consortia of the European Union or the
National Institues of Health, IBT wants to act as a catalyst
in encouraging Israel’s thought-leaders to prioritize brain
disease, and to participate in this global challenge. It is
notable that that two central figures in Brain Research and
public funding in the West are speaking at the event: firstly,
U.S. Congressman Chaka Fattah (D-Penn.), of the Obama–
backed $100 million BRAIN project; Fattah’s initiative
has previously led to the Interagency Working Group on
Neuroscience (IWGN), housed at the White House Office of
Science and Technology Policy (OSTP); and secondly, Henry
Markram, PhD, Professor of neuroscience at the Swiss
Federal Institute for Technology (EPFL, Lausanne,
Switzerland) and Coordinator of the Human Brain Project,
one of two ten-year €1 billion ($1.3 billion) Flagship Projects
selected in January 2013 by the European Commission.
“We see that Israel is a promising hub for the next
phase of neuro-technologies. We want to bring more Israeli
technologists to the world of neurology, and to get the
world’s brain technologists to see Israel as a natural partner
for collaboration. Israel could become a hub for novel neuro-
technologies, much as it is an undisputed hub for biomedical
devices,” said IBT Executive Director Miri Polachek.
One of the high-value elements of this conference is
the apparent ‘technology-agnostic’ approach that is being
used to address the problems at hand. Neurology is so
complex, that whether electro-stimulation, RF ablation or
drug therapy is being applied, and whether MRI, ultrasound,
or a molecular biomarker is being used to pick up biological
signals . . . we want to know about it,” said one key brain
technologist. From a clinical treatment perspective,
neurology is still in its infancy, and at this stage, the cross-
disciplinary approach is not desired, it is required.
IBT requested a detailed analysis from McKinsey
& Company Consultants (London) to address Israel’s
potential as a hub for neuro-technology in the coming
years. The field of Brain Technology remained largely
untouched by decades of extensive medical and clinical
research. McKinsey recommended specific areas within the
brain-study spectrum that would most easily and naturally
suit Israel as a center of excellence, based on its proven
technological skills. This analysis helped guide IBT in
developing the roadmap of activities in coming years.
McKinsey advised, among other things, that to bring
Braintech into Israeli hearts and minds, it would be essential
to create a breeding ground for the brain-tech field both
internally (within Israel) and externally — from the outside
in. To generate internal Israeli stimuli — as well as external
groups using Israel as a neuro-technology hub — Israel
needed to establish a convention of this type, promoting a
high-profile competition that could create a long-term first-
mover advantage for the Israeli neuro-technology franchise.
As a result of this recommendation, one of the
highlights of this conference is a privately-funded $1
million prize competition: — “Breakthrough Research And
Innovation in Neurobiology” (“B.R.A.I.N.” — how about
that!). The competition is designed to generate thought and
innovation, and to define IBT as a clinical solutions-oriented
organization, rather than an academic interest group.
From over 70 submitted projects from U.S., Europe
and Israel, 10 finalists have been chosen, all of which have
projects beyond the proof of concept; more than being
merely ‘promising,’ these groups were largely chosen
due to their game-changing potential, also validated by
their results to date. Further aligning with the application-
focus of the event, the conference exhibition (Neurocity),
addresses Israeli and European developments in the field,
which are already heading towards commercialization.
A couple of the cutting edge technologies, both of
which have reached the competition finals, are described
below.
One of the harder mysteries to unravel is the way
neurons and associated neural networks communicate
with one another, and how they function — or fail to
function, which then leads to many neurological diseases.
Relating neural dynamics to animal behavior has been
a longstanding challenge in neuroscience. An enabling
technology has been invented by Inscopix (Palo Alto,
California). Inscopix has designed a miniature, integrated
fluorescence microscope; each microscope weighs less
than 2g, and sits comfortably on the head of an adult
mouse. These devices have been used by neuroscientists at
Stanford to image calcium dynamics in individual neurons
during standard animal behavior. Such studies were record-
breaking, both in terms of the sheer numbers of neurons
(up to ~600 cells per mouse) that were monitored in each
animal, and in terms of the deep locations of some of the
brain areas studied. The team has developed a method
to continuously monitor these individual neurons over
many months. In addition, their system enables hundreds
of individual neurons’ calcium dynamics and functions
See Braintech, Page 10

PAGE 7 OF 10
Denver
Device Daily his view that “there is a frontier mentality in
Colorado which makes it easier to do tech transfer. People
are entrepreneurial and willing to take risks.” He lamented
that it is difficult to raise venture capital and that “you have
to go on a plane to visit VC firmsThe following medical
device companies in Metro Denver is representative of their
diversity.”
ValveXchange (Greenwood Village) was formed in
2007 and is developing Vitality, a two-part bioprosthetic
heart valve comprised of a permanent base and removable
leaflet set that is seated onto the base. The valve is
fabricated from bovine pericardial tissue. It is implanted
in two steps and offers advantages of improved visibility
during implantation and use of an exchangeable clip-on
leaflet set that simplifies re-do procedures. The valve is
in a 45-patient clinical trial in Europe at 6 facilities in 3
countries. The company anticipates receipt of the CE mark
by the end of 2013 and plans to begin a clinical trial in the
U.S. in 2014. Larry Blankenship, president of ValveXchange
said that “there has been no real innovation in surgical
heart valves since the 1980s, until now. Bioprosthetic
heart valves have increased in their market penetration
because patients can have a full active lifetime without
Coumadin.” He further noted that “mechanical heart
valves are on their way out with under 10% of valves used
in the U.S. and under 30% in Europe.” The company is
conducting a Series B financing and seeking to raise $20
million. CryoLife (Kennesaw, Georgia) is an investor in
ValveXchange.
Surefire Medical (Westminster) was founded in July
2009 and began marketing in late 2011 its microcatheter for
infusion of chemotherapeutic drugs for targeted delivery
to a liver tumor. The device has a proprietary expandable
tip that prevents reflux of therapeutic agents to non-target
vessels and minimizes potential damage to healthy tissue.
The microcatheter is inserted via the femoral artery using
angiography for visualization. It is sold to interventional
radiologists and to interventional oncologists, a new
subspecialty. This chemo-embolization procedure reduces
tumor size with fewer complications and more rapid
recovery than traditional surgery. The procedure is for use
on patients that are not candidates for liver transplant.
The microcatheter is manufactured by Innovia (Miami)
and is used in more than 80 U.S. hospitals and is sold in 14
countries in Europe and Asia. Jim Chomas, Surefire’s CEO,
explained that “85% of metastatic diseases end up in the
liver and with systemic chemotherapy it is challenging
to get a sufficient dose into the tumor without killing the
patient.” The company recently entered into collaboration
with principal investigators at Johns Hopkins Hospital
(Baltimore) and the National Institutes of Health (NIH;
Bethesda, Maryland) for use of its targeted embolization
technology in a minimally invasive treatment of obesity,
as an alternative to bariatric surgery. Discussions are
underway with the FDA to do an IDE Phase I/II trial on obese
patients. Also under consideration is the potential use of
Surefire’s technology for prostatic artery embolization as
a treatment for BPH.
PharmaJet (Golden) was founded in 2005 and entered
the U.S. market in 2009. It markets the Stratis spring-loaded
needle-free injection system for use in intramuscular
and subcutaneous delivery of vaccines and medicines. It
features a single-use, auto-disabling and disposable syringe
that delivers a fixed fluid volume of 0.5 ml. PharmaJet has
strategic relationships with CSL Behring (King of Prussia,
Pennsylvania) Inviragen (Fort Collins, Colorado), the U.S.
Army Medical Research of Infectious Diseases
(USDAMRIID;Frederick,Maryland),andtheSerum Institute
of India (Pune, India).
Sophono (Boulder) markets in Europe and the U.S. a
bone-anchored hearing device for patients with conductive
hearing loss. A condition which represents 10% of the total
hearing impaired population. Most hearing impairment is
due to sensorineural hearing loss which typically occurs
during the aging process. Sophono’s device is entirely
implanted, unlike competing products from Cochlear (New
South Wales, Australia) and Oticon (Copenhagen/Somerset,
New Jersey) which are only partially implanted with a screw
protruding outside the scalp. Jim Kasic, president/CEO of
Sophono, said that global sales of bone-anchored hearing
devices are $120 million. He projects that it will quadruple
over the next decade.
Sharklet Technologies (Aurora) is developing
micro-texture surface technologies that are designed
to inhibit the colonization and growth of bacteria. The
premise of this technology is that bacterial colonization
can be controlled by surface topography alone. Its
patented surface texture is comprised of raised,
microscopic features arranged in distinct diamond
shapes to form a continuous pattern. The company’s
objective is to integrate the Sharklet texture into surfaces
of medical devices and high-touch surfaces that are used
daily to reduce human exposure to disease-causing
bacteria. The technology is based on research conducted
by Professor Anthony Brennan in the Department of
Materials Science and Engineering at the University
of Florida (Gainesville) who also serves as Sharklet’s
Chief Technology Officer. The company has an SBIR grant
from the NIH to explore application of its technology
to intraocular lenses. It has licensed to Cook Medical
(Bloomington, Indiana) the use of its surface technology
on urological devices for reducing the migration of
bacteria. Sharklet envisions receipt of a 510(k) for this
application and a product launch in 2014. Mark Spiecker,
CEO of Sharklet, expressed interest in researching the use
of the company’s surface technology on hydrocephalus
shunts to prevent blockage from cellular growth and on
vascular access devices to reduce platelet adhesion. ■

PAGE 8 OF 10
Europe
aortoplasty, aortic valve procedures, valve procedures,
Bentall procedure, composite valve conduit procedure,
mitral valve replacement, Ross procedure, proximal
coronary anastomoses, aortic aneurysm repairs, aortic wall
replacement, ascending aorta repair.
• Peripheral vascular reconstructions: aorto-femoral
bypass, aorto-iliac bypass, aortic bypass, aorto-innominate
bypass, carotid bypass, carotid endarterectomy, femoral-
distal bypass, femoral-femoral bypass, femoral-popliteal
bypass, hepatic-renal bypass, popliteal-dorsalis pedis
bypass, profunda endarterectomy, renal bypass, extremity
bypass, renal endarterectomy, hemodialysis access,
arteriovenous graft.
• Soft tissue repair involving sutures and staples:
cardiac wound repair, pancreatic anastomotic leak, hepatic
resection, splenic bleeding, biliary leaks, esophageal repair,
colorectal repair, stapled gastrojejunostomy and lymphatic
leaks.
“We are very pleased to have been informed by our
European Notified Body of the expanded indications for
ArterX Surgical Sealant. It adds a new tool for the surgeon to
assist in improving the care and outcomes for the patient,”
said Ronald Dieck, president/CEO of Tenaxis Medical.
“Application of ArterX Surgical Sealant to bleeding sites has
been shown to reduce suture line bleeding. This has a direct
impact on reduction of operating room and hospitalization
times as well as loss of blood.”
In addition to ArterX Surgical Sealant, which is
commercially available in the U.S. and Europe, Tenaxis
is developing other functionally designed products to
meet key medical needs. These include a second high-
performance sealant, Prevent GI Sealant, for use throughout
the gastrointestinal tract, and an anti-surgical adhesion
agent, PeriGlide Adhesion Prevention that can be delivered
laparoscopically to help prevent or reduce pelvic and
abdominal adhesions.
Keystone gets CE mark for TriGuard
Keystone Heart (Caesarea, Israel) reported that
its TriGuard cerebral protection device has received CE
marking, enabling the company to commercially market
the TriGuard in Europe and other territories. According to
the company, the TriGuard is the only device designed to
cover all three aortic cerebral branches to minimize the
risk of cerebral damage during transcatheter aortic valve
replacement (TAVR) and other cardiovascular procedures. It
is the only system designed for placement via one of two
femoral artery access ports, the company also said. The
TriGuard is designed to accommodates most anatomical
variations of the aortic arch and uses a Nitinol frame and
mesh intended to be flexible and atraumatic, yet robust and
sturdy.
“TriGuard is the most sophisticated cerebral embolic
protection device currently available,” said Andreas
Baumbach, MD, consultant cardiologist at the University
Hospitals Bristol in the UK. “The device has the potential
to become a routine preventive measure in TAVI and
other cardiovascular procedures associated with embolic
lesions. European approval of the TriGuard device is an
important advancement in patient care.”
Keystone noted that new scientific data presented
at EuroPCR demonstrated a significant reduction of new
brain lesion volume during TAVR using the TriGuard
device, compared with historical data on unprotected TAVR
procedures. The clinical data shows that maximum total
lesion volume was 95% smaller and average total lesion
volume was 57% smaller when compared with historical
references.
The medical community is witnessing heightened
focus and scrutiny on cerebral injury concurrent with
cardiovascular procedures - and research on possible
preventative measures and devices to protect against brain
injury has increased. Data from the PARTNER A study show
nearly twice as many strokes in the TAVR group compared
with the surgical aortic valve replacement (AVR) group at
30 days, the majority of strokes being peri-procedural
and within the first two days. In addition, newer “next
generation” TAVR devices have so far have apparently failed
to reduce TAVR-related risk of stroke.
These data affirm that protecting the brain is an
important goal during TAVR and that TriGuard may provide
such protection during TAVR and other cardiovascular
procedures, the company said. The device is not yet
commercially available in the U.S. ■
VirtualScopics regains Nasdaq compliance
VirtualScopics (Rochester, New York), a provider
of quantitative imaging, has received notification from
The Nasdaq Stock Market that it has regained compliance
with the minimum $1 per share bid price requirement, and
further, that it complies with all other applicable standards
for continued listing.
To regain compliance with the bid price rule, the
company was required to evidence a closing bid price of
$1 per share or more for a period of at least 10 consecutive
trading days. The company effected a reverse stock split
with a ratio of 1-for-10 on Aug. 21, 2013. On September 5, the
closing price of the company’s common stock was $4.84
per share which marked the tenth consecutive day the
stock price had a closing bid price above $1 per share. Since
the company has achieved compliance with the bid price
rule, there is no need for the company to initiate the appeal
process with Nasdaq.
Med-Tech NotesMed-Tech Notes

PAGE 9 OF 10
Washington
The Sept. 6 OIG report says that while each of the 50
states set their own rates for DME, the White House budget
proposal for fiscal 2014 “emphasized cost containment by
Medicaid programs,” including a proposal to limit federal
reimbursement for Medicaid spending “on certain DME
services to what Medicare would have paid in the same
state for the same services.”
OIG says that it checked on fee-for-service (FFS) Medicaid
payments for 32 DME items paid in the Dallas-Fort Worth (DFW)
area in 2011, and determined that had the state of Texas limited
payments for Medicaid FFS DME to the amounts paid under the
Medicare DME bidding program, the savings to the state and
federal government would have come to roughly $2 million.
The report indicates that Texas Medicaid spent roughly $12
million on these 32 items for the DFW area that year.
OIG did not recommend a bidding program for DME
under Medicaid, but said that substantial savings could be
had if state Medicaid programs “were to use the Medicare
competitive bidding program amounts rather than the State
Medicaid fee-schedule amounts.”
Jay Witter, senior director of government affairs for the
American Association for Homecare (AA Homecare;
Washington) told Medical Device Daily that the notion of
tying Medicaid DME under FFS providers to the bid Medicare
price is nothing new. “This has been in President Obama’s
budget in the last four years,” Witter said, but he noted that
legislators “have not included it in legislation because they
know it’s just bad policy.”
“We have communicated with the Hill over the last four
years and will continue to communicate with them on this
issue,” Witter vowed, but he added that he sees something
of a mixed message in the OIG report.
“It almost seems like they’re recommending that this is a
good way to save money . . . but there’s no recommendation
here. I question what the point of the report is,” Witter said,
adding that OIG “admitted it’s an extremely limited study.”
“You have [Medicare bid] rates we continue to have
concerns with, but they’re based on having contracts and
increased volume,” Witter remarked. He argued, “by taking
those rates and expanding them outside the bid areas,
it would be even worse than the policy for competitive
bidding.”
Witter said he was not sure how total Medicare and
Medicaid DME spending compare with each other, but noted
that the states determine the rates paid for Medicaid DME.
He remarked, “for most of the state [of Texas], Medicaid is
[paid] less than Medicare, and they didn’t state that either.”
He also said OIG “should have mentioned that they’re
investigating the process of how those bid rates were set”
in the Medicare DME bidding program.
Hamburg sees a need for overhaul of FDA
The Center for Devices and Radiological Health has seen
a fair amount of revamp of its work, but FDA commissioner
MargaretHamburg,MD,nowhasinmindacompleterewiring
of the entire agency in an effort to optimize the agency’s
ability to perform its functions. However, the memo offers
no timelines for achievement of this retooling process.
The Sept. 6 internal memorandum makes note of several
piecesoflegislationthathaveexpandedtheagency’smission
substantially, and explains that in the commissioner’s view,
FDA will have to “transition to distinct commodity-based
and vertically-integrated regulatory programs.” She notes
that this will require “a de-layered management structure,”
along with “a specialized program-based model.” She notes
that this overhaul of the organization “will take time” and
will require “discussion in the near term regarding roles and
responsibilities, metrics and accountability, and decision
rights.”
Among the specific tasks assigned to the center
directors and the Office of Regulatory Affairs is to develop
plans toward “specialization . . . across FDA’s inspection and
compliance functions” in a way that would enable FDA “to
mirror, adapt to, and track the continuing program-based
specialization within FDA’s regulated industries and the
demands of new legislation.”
The agency’s compliance function will be reworked to
produce “policy and enforcement strategies that are clear,
current, outcome-based, and effectively communicated in
order to maximize FDA’s ability to protect public health and
to exercise effective and efficient industry oversight,” the
memo says. Hamburg asked the center directors to report
on these matters “within the next three months.”
ACR against CCRs for radiology
The controversy over the use of cost-to-charge ratios
to calculate payment levels for radiology continues to
encounter resistance, this time in the form of a Sept. 4 letter
from the American College of Radiology (ACR; Reston,
Virginia), voicing the association’s displeasure with the CCR
proposal for outpatient imaging.
The letter notes that ACR “strongly opposes this
proposal,” asserting, “the significantly lower CCRs for CT
and MR (compared to the CCR for general radiology) lack
face validity and should not be used for payment purposes.”
ACR’s comments largely mirror those made by the Medical
Imaging & Technology Alliance (MITA; Arlington,
Virginia), which also indicated that the plan introduced
payment anomalies (Medical Device Daily, Sept. 9, 2013).
ACR says that an analysis it commissioned five years
ago “showed that the technical payment for CTs ($64) would
fall below the payment of a chest X-ray ($99).” The statement
claims that an analysis of hospital data from 2011 “shows
that a CT scan of the head/brain would be reimbursed at
$84 (down from $206) and an X-ray of the skull would be
reimbursed at $82 (up from $45).”
ACR recommended CMS continue using the single-
diagnostic cost-to-charge ratio. ■

PAGE 10 OF 10
commercial members, along with CarePlus Health Plans
Medicare members, to continue receiving care at HCA’s
affiliated hospitals and medical facilities in South Florida,
Tampa Bay, Central Florida, Jacksonville and Northwest
Florida.
The existing Florida Medicare and commercial network
contractwithHCA’saffiliatedhospitalsandmedicalfacilities,
Humana and CarePlus (Miami-based Medicare Advantage
HMO owned by Humana) was scheduled to expire in August.
Under the new statewide network agreement, more
than one-million Florida members of Humana’s commercial,
Medicare, Medicaid and individual health plans will continue
to have access to close to 40 HCA-affiliated Florida hospitals,
stretching from South Florida to Tampa Bay to North Florida,
for all covered inpatient and outpatient services.
• iTech Medical (Huntington Beach, California) has
enteredintoanexclusiveproductanddistributionagreement
with Back-A-Line (San Francisco). iTech reported that the
agreement will cover all aspects of a unique product for
chronic back pain sufferers that combines iTech’s patented
Composite Concentric Circle (C3) magnet technology with
Back-A-Line’s patented Dynamic Back Support system.
iTech’s C3 magnet technology is marketed by BIOflex
Medical Magnetics, Inc., a wholly-owned subsidiary of iTech.
iTech reported that the product and distribution
agreement with Back-A-Line covers all aspects relating to
the manufacturing, marketing and sales of the combined
back support product. Profit sharing will be based on a
formula that incorporates total combined sales, cost of
goods and marketing costs.
iTech Medical is a medical device company that makes
medical devices and technologies for the rehabilitation,
to be tracked over weeks of active mouse behavior. Such
data sets are unprecedented, and cannot be gathered by
state-of-the-art imaging or electrophysiology recording
techniques. This breakthrough approach should lead
to crucial new knowledge on how neural circuits shape
mammalian behavior, and how normal circuit processes go
awry leading to diseases; this could have a major impact
on our understanding and treatment of many neurological
disorders.
Another groundbreaking company among the potential
winners of this event’s BRAIN prize is Insightec (Tirat
Carmel, Israel) which has applied itself directly to the
world of brain therapy. Using its proprietary MRI-guided
Focused Ultrasound modality, the company can focus its
ablation techniques accurately — through the closed skull
— and manage/monitor the exact effect by associated
technology. The ability to offer — and monitor — sub
millimeter accuracy with no impact on surrounding tissue
using MRI image guidance makes this treatment modality
ideal for many brain disorders, where accuracy and limited
collateral damage are more critical than in many other
surgical ablation applications. While the ExAblate Neuro
system is currently approved in Europe for thalamotomy
for Essential Tremor, Parkinsonian Tremor and Neuropathic
pain, it is currently being evaluated in the U.S. in a number
of advanced trials. Beyond these major game-changing
applications, it may also advance as a highly-controllable
non-invasive neuro-modulation technology which will
revolutionize our understanding of the human brain.
Today’s research tools, diagnostic systems and
treatment modalities should — with suitable support
from public and private funders — find a home in this
niche of brain technologies. If events such as this
upcoming Israeli BrainTech conference can encourage
a cross-disciplinary culture of innovation in the field,
we can hope that in the not-too-distant-future, some
of today’s most debilitating conditions could advance
towards therapeutic solutions. ■
Braintech
Agreements
sports medicine and pain management markets.
Back-A-Line has developed a line of commercial
products based on its patented Dynamic Back Support
technology. ■
Enhance Corporate
Strategies with our
State of the Industry
Report 2013
Discover new strategies to
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STATE INDUSTRY
REPORT 2 0 1 3
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M E D I C A L D E V I C E D A I L Y
INSIGHTS AND INNOVAT IONS FROM INDUSTRY LEADERS

MDD’s Cardio Extra
TUESDAY, SEPTEMBER 10, 2013 PAGE 1 OF 2
A D D I T I O N A L DE V E L O P M E N T S I N ON E O F ME D -T E C H ’ S K E Y SE C T O R S
Keeping you up to date on recent developments in cardiology
Molecular beacons light path to cardiac repair . . . Pure cardiac muscle cells, ready to trans-
plant into a patient affected by heart disease is the goal for many cardiology researchers working with stem cells. Having
a pure population of cardiac muscle cells is essential for avoiding tumor formation after transplantation, but has been
technically challenging. Researchers at Emory University School of Medicine and Georgia Tech (both Atlanta) have
developed a method for purifying cardiac muscle cells from stem cell cultures using molecular beacons. Molecular beacons
are tiny instruments that become fluorescent only when they find cells that have turned on certain genes. In this case, they
target instructions to make a type of myosin, a protein found in cardiac muscle cells. Doctors could use purified cardiac
muscle cells to heal damaged areas of the heart in patients affected by heart attack and heart failure. In addition, the
molecular beacons technique could have broad applications across regenerative medicine, because it could be used with
other types of cells produced from stem cell cultures, such as brain cells or insulin-producing islet cells. The results are
published in the journal Circulation. “Often, we want to generate a particular cell population from stem cells for introduc-
tion into patients,” says co-senior author Young-sup Yoon, MD, PhD, professor of medicine (cardiology) and director of stem
cell biology at Emory. “But the desired cells often lack a readily accessible surface marker, or that marker is not specific
enough, as is the case for cardiac muscle cells. This technique could allow us to purify almost any type of cell.” Gang Bao,
PhD, whose laboratory has pioneered the design and use of molecular beacons, is co-senior author. Bao is Robert A. Milton
chair, Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. The first authors are
Emory postdoctoral fellow Kiwon Ban, PhD and Georgia Tech graduate student Brian Wile. Ban, Wile and their colleagues
cultured stem cells with growth factors, which induced them to differentiate into clumps of spontaneously beating cardiac
muscle cells. The experiments used embryonic stem cells or separately, induced pluripotent stem cells, from either mice or
humans. For human cells, it takes about two weeks for cardiac muscle cells to form in large numbers. The molecular bea-
cons are designed to become fluorescent only when they find messenger RNA with the right genetic sequence. Using
molecular beacons together with a flow cytometer, which sorts cells based on fluorescence, allowed researchers to pick out
the cardiac muscle cells. The purified cells could engraft into the damaged hearts of mice after a simulated heart attack, and
the graft improved the heart’s pumping power (ejection fraction). Recovering animals that received no cells had their ejec-
tion fraction fall. When unpurified cells were grafted into mice, all the mice developed teratomas: tumors derived from the
stem cells. The researchers noted that only mouse stem cells were transplanted into mice. An important next step for devel-
oping purified cardiomyocytes as a therapy for heart diseases, Yoon says, is to engineer them into artificial tissues. “In
previous experiments with injected bare cells, investigators at Emory and elsewhere have found that a large proportion of
the cells are washed away,” he said. “We need to engineer the cells into compatible biomaterials to enhance engraftment
and retention.”
New strategy to triage patients with suspected ACS can increase rate of early,
safe hospital discharge . . . An emergency department strategy that uses two biomarkers to triage patients
with suspected acute coronary syndrome (ACS) can increase the rate of early, safe hospital discharge, according to results
of the Biomarkers in Cardiology 8 (BIC-8) trial. “This biomarker strategy using a state-of-the-art quantitative troponin assay
in combination with an ultrasensitive copeptin assay has the potential to change clinical practice with high patient safety,”
said lead investigator Martin Möckel, MD, PhD, from Charité - Universitätsmedizin Berlin (Berlin). “This is the first inter-
ventional trial to study whether it is safe to discharge suspected ACS patients who test troponin and copeptin negative at
admission. Using this strategy, a high proportion of patients could be discharged early, thus unnecessary treatments and
resources could be saved, causing a substantial benefit for patients and healthcare providers.” Emergency departments
worldwide face increasing overcrowding and patients with signs and symptoms which might be caused by an acute coro-
nary syndrome are very common, even though only around 15% of these patients are ultimately diagnosed with an acute
myocardial infarction as the underlying disease, explained Möckel. “Rapid rule-out of acute myocardial infarction (MI) is
therefore a major clinical need, saving the healthcare system time and resources and patients unnecessary stress, anxiety
and other risks associated with hospitalization.” Current guidelines recommend that patients receive serial troponin testing
to confirm that hospital discharge is appropriate, but this testing delays definitive action, he said. “The new biomarker
copeptin has been shown to be elevated in patients first presenting with acute MI, and when combined with the cardiac

TUESDAY, SEPTEMBER 10, 2013 MDD’S CARDIO EXTRA PAGE 2 OF 2
troponin biomarker has an excellent negative predictive value for acute MI. However, an early discharge strategy based on
combining these two tests has never been assessed prospectively.” BIC-8, a multicenter, open, randomized, controlled
clinical trial included 902 patients with an initial negative troponin test to assess this strategy. In the experimental arm (451
patients), patients with a negative copeptin test (less than 10 pmol/L) were discharged into ambulant care, with a scheduled
outpatient visit within 72 hours, while those with a positive copeptin test received standard treatment according to current
guidelines. Among patients in the standard arm (451 patients), copeptin results were not available to treating staff and
patients were treated according to current guidelines. At 30 days of follow-up the rate of major adverse cardiovascular
events (MACE) was similar in both groups (5.46% in the experimental arm vs 5.5% in the standard arm), but emergency room
discharge rates were significantly higher in the experimental arm (66% vs 12%). The results support the consideration of a
new treatment algorithm in low-to-intermediate risk patients with suspected ACS, Möckel said. “Patients with a negative
troponin and a negative copeptin result at admission can safely be discharged if the final clinical assessment is consistent
with this decision, as long as a timely diagnostic work-up is done in the outpatient setting,” he said. However, the clinical
judgment of the treating physician is of utmost importance, he stressed. “If his or her final clinical assessment excludes
discharge due to high suspicion of ACS, perhaps due to recurrent symptoms or an updated history, the patient should not
be discharged despite negative biomarker results.”
Heart attack rate unchanged despite faster door-to-balloon time . . . Heart attack
deaths have remained the same, even as hospital teams have gotten faster at treating heart attack patients with emergency
angioplasty, according to a study in this week’s New England Journal of Medicine. Hospitals across the country have raced
to reduce so-called door-to-balloon time, the time it takes patients arriving at hospitals suffering from a heart attack to be
treated with angioplasty, to 90 minutes or less in the belief that it would save heart muscle and lives. In an analysis led by
the University of Michigan Frankel Cardiovascular Center (Ann Arbor) of 100,000 heart attack admissions across the
U.S. between 2005 and 2009, a time period that coincided with a national effort to reduce door-to-balloon time, 4.7% of
patients died. The rate was virtually unchanged in spite of the faster care. “The data suggests that efforts to reduce door-
to-balloon time further may not result in lower death rates,” says lead study author and interventional cardiologist Daniel
Menees, MD, assistant professor of internal medicine at the University of Michigan Medical School. “Potential strategies to
improve care may include increasing patient awareness of heart attack symptoms, reducing delays for treatment once
symptoms begin, and shortening transfer time between healthcare facilities once a heart attack is recognized.” Door-to-
balloon time describes the amount of time between when a patient arrives at the hospital and when they receive percutane-
ous coronary intervention (PCI), such as angioplasty, in which a catheter with a small balloon at the tip is inserted and
inflated to open a blocked artery. The study of patients treated for heart attack at 515 hospitals participating in the CathPCI
Registry found door-to-balloon time fell from 83 minutes in 2005-2006 to 67 minutes in 2008-2009. The findings show the
result of collaboration and teamwork among teams led by cardiologists, emergency medicine physicians and emergency
medical services to reduce the time it takes to treat a heart attack. Healthcare quality has been measured by how well hos-
pitals meet the 90-minute time goal. The U-M Health System is among those hospitals reporting its own performance pub-
licly on the Internet. “But the pendulum may have swung too far,” Menees says. “In our rush to provide treatment even faster,
we may be taking patients for angioplasty who don’t need one and possibly even placing those patients at-risk. Door-to-
balloon time is easy to measure and something we can control but it’s only a fraction of the total ischemic time,” he says.
The study showed the percentage of heart attack patients receiving care in 90 minutes or less improved from 59.5% to
83.1%. However the heart attack mortality rate remained virtually unchanged at 4.8% in 2005 and 4.7% in 2009.
— Compiled by Amanda Pedersen, MDD Senior Staff Writer
amanda.pedersen@thomsonreuters.com

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