Unique Cardiovascular Treatment Readied for Global Market: Proprietary Paccocath(R)...

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Mon May 18, 2009 2:49pm EDT

Unique Cardiovascular Treatment Readied for Global Market: Proprietary
Paccocath(R) Technology is the Only Drug Eluting Balloon with Clinical Data

WARRENDALE, Pa., May 18 /PRNewswire/ -- MEDRAD Interventional(TM)/Possis(R)
today announced that it has reached key milestones in bringing the
Paccocath(R) Technology closer to market as an option for the over 14 million
patients in the United States and Europe who suffer from Peripheral Arterial
Disease (PAD). These milestones include the selection of physician
investigators for U.S. clinical trials and the completion of a new
state-of-the-art manufacturing facility.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040309/MEDRADLOGO )  

In routine treatment of stenotic or occluded vessels, doctors widen the
narrowed vessel using an angioplasty balloon catheter. In some cases, a stent,
which is a metal scaffold, is then placed to hold the vessel open.  However,
these treatments may have limited effectiveness since, for most patients, the
vessels often re-occlude within a year after treatment.

The Paccocath technology is a proprietary drug matrix applied to the balloon
of an angioplasty catheter. When the catheter is inflated to dilate the
narrowed vessel, an anti-restenotic drug is released directly to the diseased
area.  Clinical results to date show that using the Paccocath technology
during an angioplasty procedure keeps the vessels open wider over time
compared to standard angioplasty and published reports (1) of other current
standard-of-care therapies.

Cotavance(TM) is the brand name of the drug-eluting balloon angioplasty
catheter that is currently being developed by MEDRAD
Interventional(TM)/Possis(R) that utilizes the Paccocath technology. MEDRAD is
in the process of obtaining CE Mark certification and seeking FDA approval for
its Cotavance product. William Gray, M.D. of Columbia University (New York,
New York) and Gary Ansel, M.D. of Riverside Methodist Hospital (Columbus,
Ohio) have been selected as the co-primary investigators for the U.S. clinical
peripheral pivotal trials to achieve FDA approval for Cotavance. "The safety
and efficacy outcome of the THUNDER study from Europe is a great starting
point for US clinical trials with the Cotavance product. I am very hopeful
that this technology will provide new and better treatment options for
patients with claudication," said Dr. Gray.

"Paccocath is in the unique position of being the only drug eluting balloon
technology with positive clinical science results. The THUNDER and FEM
studies, which used the Paccocath technology exclusively, show its potential
efficacy and safety in peripheral applications," said Professor Gunnar Tepe,
MD, of Klinikum Rosenheim in Rosenheim, Germany. The successful clinical
results to date achieved through the application of the Paccocath technology
have encouraged others to market coated balloons, but without the Paccocath
technology, none have proven clinical science benefits.  According to Dr.
Ansel, "The concept of drug eluting balloons is very attractive, but there may
be much more to creating a clinical effect than just putting a drug onto an
angioplasty balloon. What appears to make this technology unique is the
addition of the Ultravist(R) to the Paclitaxel, which seems to allow for
significant drug uptake in the treated vessel." 

Bayer Schering Pharma AG (Berlin, Germany) is the owner of the Paccocath
technology and is developing it for market through Bayer affiliate, MEDRAD,
Inc.  Kraig McEwen, senior vice president of MEDRAD Interventional/Possis
said, "We are working to further the scientific evidence of the Paccocath
technology with additional clinical studies in the U.S. and Europe.  These
studies are focused on achieving FDA clearance for peripheral indications and
will help us understand patient outcomes in a variety of treatment situations.
The Paccocath technology continues to be the most studied and best understood
and we believe that such careful characterization is important to ensure
patient safety and improved outcomes."

Another major milestone in bringing Paccocath technology to market has been
the completion of a balloon coating Center of Excellence facility in
Minneapolis, Minnesota, which is the primary site for balloon coating and the
development of future coating technologies and drug formulations. "Our
investments in Paccocath technology research and in the development of the
Cotavance product demonstrate our commitment to drug-eluting balloon
technology and our intent to bring the best therapy to market," said McEwen. 

Expanding the Paccocath technology to patients with heart disease, B.Braun
Melsungen AG (Berlin, Germany) has licensed the technology for use in its
SeQuent(R) Please drug eluting balloon catheter, which recently received CE
certification for the treatment of narrowing of the coronary arteries. Adding
to the clinical evidence in support of the Paccocath technology, B. Braun
conducted the PEPCAD clinical studies, which provided evidence in support of
its use in coronary arteries.

About MEDRAD Interventional/Possis 
Possis Medical, a pioneer in the field of thrombus removal, has recently
merged with MEDRAD, the leader in diagnostic and interventional contrast
injection. Together, they have formed MEDRAD Interventional / Possis, a
division of MEDRAD, INC., focused on advancing interventional medicine through
research and innovation. With manufacturing facilities in both Minneapolis, MN
and Pittsburgh, PA, MEDRAD Interventional / Possis manufactures and markets
segment-leading medical devices such as AngioJet(R) Thrombectomy Systems,
MEDRAD Avanta(R) Fluid Management Injector Systems, Mark V ProVis(R)
Angiographic Contrast Injectors, the GuardDOG (R) Occlusion System, FETCH(R)
Aspiration Catheters and the SafeSeal(R) Hemostasis Patch.

About MEDRAD, INC.
MEDRAD, INC. develops, markets and services medical devices used to diagnose
and treat disease. Its product offerings include fluid injection systems for
radiology and cardiology, endovascular devices for the safe treatment of
cardiovascular disease, magnetic resonance-compatible accessories and
equipment services. MEDRAD's total 2008 revenues were over $600 million. The
company's world headquarters is near Pittsburgh, Pennsylvania, in the United
States. MEDRAD is a business of Bayer Medical Care. More company information
is available at www.medrad.com.

Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer
Care, Medical Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.

Cautionary statement regarding forward-looking statements.
Certain statements in this press release that are neither reported financial
results nor other historical information are forward-looking statements,
including but not limited to, statements that are predictions of or indicate
future events, trends, plans or objectives. Undue reliance should not be
placed on such statements because, by their nature, they are subject to known
and unknown risks and uncertainties and can be affected by other factors that
could cause actual results and Bayer's plans and objectives to differ
materially from those expressed or implied in the forward-looking statements.
Bayer undertakes no obligation to update publicly or revise any of these
forward-looking statements, whether to reflect new information or future
events or circumstances or otherwise.

(1) Duda SH, Bosiers M, Lamme J, Scheinert D, Zeller T, Oliva V, Tielbeek A,
Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H,
Beregi JP. Drug-eluting and bare nitinol stents for the treatment of
atherosclerotic lesions in the superficial femoral artery: long-term results
from the SIROCCO trial. J Endovasc Ther. 2006; 13: 701-710.


SOURCE  MEDRAD

Luanne Radermacher of MEDRAD, +1-724-940-7968, lradermacher@medrad.com
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