MEDRAD, INC. Announces European Approval and Launch of the Cotavance(TM) Drug Eluting Balloon With Paccocath(R) Technology

By Medrad Inc., PRNE
Monday, May 16, 2011

Additional Clinical Studies and Technological Advancements for the Cotavance Catheter Underway

WARRENDALE, Pennsylvania, May 17, 2011 - MEDRAD, INC., a business of Bayer HealthCare, today announced it has
received CE Mark for its Cotavance(TM) Paclitaxel Coated Balloon Angioplasty
Catheter with Paccocath(R) technology. The Cotavance catheter is used in
percutaneous interventions for the treatment of peripheral arterial disease
(PAD) and is approved for balloon dilation of stenotic lesions in the iliac
and infrainguinal arteries while applying paclitaxel to the vessel wall to
inhibit restenosis. MEDRAD Interventional has started selling its Cotavance
catheter in countries where it has already received regulatory approval,
including select European and Middle East countries.(1) The announcement was
made in conjunction with the Congress of the European Association of
Percutaneous Cardiovascular Interventions (EuroPCR) in Paris.

"Effective treatments for peripheral artery disease continue to be a
major medical challenge," said Professor Gunnar Tepe, MD, of Klinikum
Rosenheim in Rosenheim, Germany. "The recent European approval of the
Cotavance catheter offers an innovative new approach for improving patient
outcomes. Importantly, the only positive long-term clinical results to date
with drug-eluting balloons have used the Paccocath technology to successfully
keep coronary and peripheral vessels open wider over time compared to
standard therapies."(2),(3),(4),(5),(6)

The Paccocath technology is a proprietary drug matrix applied to the
balloon of an angioplasty catheter. The matrix consists of paclitaxel, long
used in drug-eluting stents to treat cardiovascular disease, and a radiologic
contrast agent, Ultravist(R) 370. When the balloon is inflated to dilate the
narrowed vessel, paclitaxel is delivered directly to the diseased area. Bayer
Schering Pharma AG is the owner of the Paccocath technology and MEDRAD
Interventional is developing and marketing it under the brand name Cotavance.

MEDRAD's commitment to further advancing the treatment of PAD is
demonstrated by the initiation of randomized clinical studies examining the
safety and performance of the Cotavance product for treating diseased
arteries above and below the knee. Two of these studies, EURO CANAL and
DEFINITIVE AR (sponsored by ev3 Inc., a Covidien company, using Cotavance
catheters), are expected to begin enrolling patients this summer.
Additionally, the COPA CABANA and RIVER studies will be initiated at a later
date. Collectively, these studies will enroll more than 640 patients in
approximately 90 sites around the world. Information from these studies is
intended to expand the scientific evidence of the Cotavance catheter and
Paccocath technology and should provide valuable data for the clinical
community toward optimum care for patients suffering from PAD.

In addition to initiating clinical studies, MEDRAD is continuing to
advance the technology of Cotavance paclitaxel-eluting balloon angioplasty
catheters. MEDRAD is pursuing CE Mark certification for the next-generation
Cotavance product with innovations that include enhanced drug dose
application, a new catheter platform and a full range of catheter sizes. This
advanced technology is expected to be available in Europe in the second half
of 2011. The company is also moving forward with the Investigational Device
Exemption (IDE) process as one of the steps in gaining FDA approval for
Cotavance product in the United States.

"The European approval of the Cotavance catheter, preparation for its
next-generation product launch, and initiation of additional randomized
clinical studies underscore our commitment to further advancing peripheral
arterial disease treatment, particularly as restenosis remains a significant
issue for many patients," said Jack Darby, vice president of MEDRAD
Interventional. "As a key participant in the endovascular market, MEDRAD is
pleased to offer this treatment even as we actively pursue additional
innovations and clinical studies with the Cotavance product globally."

MEDRAD Interventional is comprised of MEDRAD, INC. and Possis Medical,
two pioneering innovators of endovascular and interventional cardiology
products. Focused on the research and development of advanced technologies,
MEDRAD Interventional designs, manufactures and markets devices that enable
interventional physicians to better see and treat coronary and vascular
disease. Paccocath, Cotavance, and Ultravist are trademarks of Bayer Schering
Pharma AG, and are used under license by 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 treatment
of cardiovascular disease, magnetic resonance-compatible accessories and
equipment services. MEDRAD is a two-time recipient of the Malcolm Baldrige
National Quality Award, the top honor a U.S. company can receive for quality
and business excellence (2003 and 2010). The company's world headquarters is
near Pittsburgh, Pennsylvania, in the United States. MEDRAD is a business of
Bayer HealthCare. More company information is available at

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
subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), 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. Bayer HealthCare's aim is to discover and
manufacture products that will improve human and animal health worldwide.
Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010)
and is represented in more than 100 countries. Find more information at

Forward-looking statements

This news release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management. Various
known and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial situation,
development or performance of the company and the estimates given here. These
factors include those discussed in Bayer's public reports which are available
on the Bayer website at The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments.

(1) Cotavance is not approved or available for sale in the United States.

(2) Tepe G et al. 2008. Local delivery of paclitaxel to inhibit
restenosis during angioplasty of the leg. N Engl J Med. 14; 358 (7):689-99.

(3) Unverdorben M. et al. 2009. Paclitaxel-Coated Balloon Catheter versus
Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis.
Circulation. 2009;119:2986-2994.

(4) Scheller B. et al. 2008. Two year follow-up after treatment of
coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin
Res Cardiol. 97(10):773-81.

(5) Werk, M. et al. 2008. Inhibition of restenosis in femoropopliteal
arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel
randomized pilot trial. Circulation. 23;118(13):1358-65.

(6) 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.

Alicia Cafardi of MEDRAD, INC., +1-724-940-8621, acafardi at; or Debra Hays of Fleishman-Hillard, +1-612-573-3152, debra.hays at, for MEDRAD, INC.

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