MEDRAD and B. Braun Melsungen AG Collaborate to Promote Breakthrough Medical Treatment for Cardiovascular Disease
By Medrad Inc., PRNETuesday, January 26, 2010
WARRENDALE, Pennsylvania, January 27 - MEDRAD, Inc. has entered into a co-marketing and trademark license
agreement with B. Braun Melsungen AG (Melsungen, Germany) to promote the
Paccocath(R) technology, a unique and clinically tested technology used to
treat blocked vessels without stenting. The Paccocath technology has been
shown in multiple clinical trials to keep the artery open wider (reduce late
lumen loss) over time in patients with Peripheral Arterial Disease and
Coronary Artery Disease (CAD).
The Paccocath technology will be used in both MEDRAD's and B. Braun's
drug-eluting balloons. Under the agreement, B. Braun is permitted to use the
Paccocath trademark in connection with promotion and marketing of its drug
eluting balloon products. Both companies will also feature the Paccocath
technology at various tradeshows, sponsored educational seminars and
symposia, and on respective informational websites.
"We feel it is important to distinguish the positive clinical results of
the unique Paccocath technology in the marketplace. This agreement allows us
to do that in cooperation with B. Braun," said Kraig McEwen, senior vice
president of MEDRAD Interventional/Possis. "We are delighted to be able to
develop and market the Paccocath technology, which provides both companies
the opportunity to offer a greater variety of products designed to improve
patient treatment and outcomes," said Gerd Wacker, senior vice president from
B. Braun, Vascular Systems.
The Paccocath technology is a proprietary drug matrix applied to the
balloon of an angioplasty catheter. The matrix consists of paclitaxel, which
has long been 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. The unique formula facilitates delivery of the paclitaxel
to the surrounding tissue. Clinical results to date (including the
THUNDER(1), PEPCAD(2), ISR(3), and FEMPAC(4) trials) show that using the
Paccocath technology during an interventional procedure keeps coronary and
peripheral vessels open wider over time compared to standard therapies(5).
Bayer Schering Pharma AG is the owner of the Paccocath trademark and
technology and is developing it for market through Bayer affiliate, MEDRAD
Inc. under the brand name Cotavance(TM). MEDRAD Inc. is in the process of
obtaining CE Mark certification and is preparing a US clinical trial to
support FDA approval for its Cotavance product.
B. Braun has licensed the Paccocath technology for use on its SeQuent(R)
Please(6) — Drug Eluting Balloon Catheter for the treatment of narrowing of
the coronary arteries. SeQuent(R) Please recently received the CE mark and is
now commercially available in all those countries which accept the CE
certificate.
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. 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.
About B. Braun
B. Braun is a leading manufacturer of infusion therapy and pain
management products with an environmentally-friendly focus. Guided by the
company's "Sharing Expertise(R)" philosophy, B. Braun addresses the critical
issues of infection prevention, medication safety and environmental
responsibility by promoting best practices that help clinicians reduce
medication errors, prevent healthcare-acquired infections (HAIs) and achieve
sustainability objectives.
Consistently recognized by Frost & Sullivan and KLAS for its medical
technology and support services, B. Braun employees share their knowledge
with colleagues and customers to improve working processes in hospitals and
medical practices and to enhance the safety of patients and healthcare
professionals. For more information, call +1-800-227-2862, e-mail us at
inquiry.us@bbraun.com or visit B. Braun at www.bbraunusa.com.
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 www.bayer.com. The company assumes no
liability whatsoever to update these forward-looking statements or to conform
them to future events or developments.
(1) 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.
(2) 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.
(3) 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.
(4) 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.
(5) 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.
(6) SeQuent(R) Please is not approved or available for sale in the United
States.
Luanne Radermacher, MEDRAD, +1-724-940-7968, lradermacher at medrad.com
Tags: Medrad Inc., Pennsylvania, Russia, Warrendale, Western Europe