WARRENDALE, Pennsylvania,
April 8, 2010 /PRNewswire/ -- MEDRAD
Interventional(TM)/Possis(R) today announced the initiation of a
supply agreement with ev3 Inc. (Nasdaq: EVVV). Under terms of the
agreement, MEDRAD will make available the Cotavance(TM) peripheral
drug-eluting balloon angioplasty catheter with Paccocath(R)
technology for study in combination with ev3's SilverHawk(R) and
TurboHawk(TM) Plaque Excision Systems for use in the DEFINITIVE AR
European pilot study for treating lower extremity peripheral
arterial disease (PAD).
The DEFINITIVE AR (Anti-Restenosis) study is a prospective,
multicenter, randomized pilot study evaluating the use of either
the TurboHawk or SilverHawk Plaque Excision System followed by
treatment with the Cotavance drug-eluting balloon catheter versus
the Cotavance balloon catheter alone in patients with peripheral
arterial disease. The pilot study will be led by Professor
Thomas Zeller, MD, of Herz-Zentrum
Bad Krozingen in Bad Krozingen, Germany and Professor Gunnar Tepe, MD, of Klinikum Rosenheim in
Rosenheim, Germany.
"Drug-eluting balloons with Paccocath technology demonstrated
encouraging safety and efficacy results in the THUNDER and FemPac
trials," said Professor Tepe. "However, I believe that treatment
outcomes could be improved by first removing plaque from the vessel
with plaque excision prior to using a drug-coated balloon. The
combination of TurboHawk or SilverHawk plaque excision followed by
the use of the Cotavance balloon catheter may allow for enhanced
drug uptake and an improved acute result and durability in the
treated vessel."
The pilot study will evaluate up to 125 patients in Europe and is anticipated to begin in the
second half of 2010. It is anticipated a global multicenter pivotal
trial will follow the completion of the pilot study.
"We are pleased to announce this collaboration with MEDRAD and
our plans for the DEFINITIVE AR pilot study," stated Robert Palmisano, ev3's president and chief
executive officer. "Despite recent advances, restenosis remains a
significant issue when treating peripheral arterial disease,
especially in patients with complex disease such as diabetes and
severely calcified lesions. We believe that the Hawk Plaque
Excision Systems' unique ability to remove the plaque layer --
thereby achieving an optimal vessel lumen -- in combination with
the Cotavance drug-eluting balloon catheter will provide valuable
data for the clinical community in treating peripheral arterial
disease."
"We are excited about the study of vessel preparation using Hawk
plaque excision followed by MEDRAD's Cotavance drug-eluting balloon
with Paccocath technology for patients with peripheral arterial
disease," said Kraig McEwen, senior
vice president of MEDRAD Interventional/Possis. "We are pleased to
collaborate with ev3, a worldwide leader in atherectomy, on this
important pilot study. We remain committed to expanding the
scientific evidence of Cotavance and the Paccocath technology with
additional clinical studies in the U.S. and Europe."
Bayer Schering Pharma AG is the owner of the Paccocath trademark
and technology, a proprietary drug matrix applied to the balloon of
an angioplasty catheter, and is developing it for market through
Bayer affiliate, MEDRAD, under the brand name Cotavance(TM). When
the balloon is inflated to dilate the narrowed vessel, paclitaxel
is delivered 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 standard
therapies. MEDRAD is in the process of obtaining CE Mark
certification and is preparing a US clinical trial to support FDA
approval for its Cotavance product.
About ev3's Plaque Excision Systems
The SilverHawk and TurboHawk Plaque Excision Systems are
catheter-based technology used primarily by vascular surgeons,
interventional cardiologists and radiologists for the treatment of
PAD. The devices use a small rotating blade to shave away plaque
from inside the artery. As it is excised, the plaque collects in
the tip of the device and then is removed from the patient, thereby
restoring blood flow with minimal barotrauma and no permanent
implant. Over 225,000 cases using the SilverHawk Plaque Excision
System have been performed since the product first became available
in 2003.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing
innovative and breakthrough technologies for the endovascular
treatment of peripheral vascular and neurovascular diseases. The
company offers a comprehensive portfolio of treatment options,
including the primary interventional technologies used today --
plaque excision systems, peripheral angioplasty balloons, stents,
embolic protection devices, liquid embolics, embolization coils,
flow diversion, thrombectomy catheters and occlusion balloons. More
information about the company and its products can be found at
http://www.ev3.net.
ev3, the ev3 logo, SilverHawk and TurboHawk are trademarks of
ev3 Inc. and its subsidiaries, registered in the U.S. and other
countries. All other trademarks and trade names referred to in this
press release are the property of their respective owners.
(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.
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
http://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
http://www.bayerhealthcare.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 http://www.bayer.com. The company
assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.