MEDRAD, Inc. Announces Supply Agreement with ev3 Inc. in Preparation for DEFINITIVE AR Pilot Trial
By Medrad Inc., PRNEWednesday, April 7, 2010
Groundbreaking Study Will Evaluate the Combination of Hawk Plaque Excision and the Cotavance Drug-Eluting Angioplasty Balloon for the Treatment of Lower Extremity Peripheral Arterial Disease
WARRENDALE, Pennsylvania, April 8, 2010 - 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
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
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.
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.
Luanne Radermacher, MEDRAD, +1-724-940-7968, lradermacher at medrad.com
Tags: April 8, Medrad Inc., Pennsylvania, Warrendale, Western Europe