Covidien (NYSE:COV), a leading global provider of healthcare products, today announced the start of patient enrollment in the ev3 DEFINITIVE(TM) AR (Anti-Restenosis) study taking place at Imelda Hospital in Belgium with Dr. Patrick Peeters.
DEFINITIVE AR is a European pilot study designed to address the challenge of restenosis (narrowing of a blood vessel) in patients with Peripheral Arterial Disease (P.A.D.). The study will look at the effects of treating a diseased vessel with plaque excision prior to the use of a drug-coated balloon.
P.A.D. is one of the most common vascular diseases and occurs when leg arteries become narrowed or blocked by plaque. For patients, these blockages can result in severe pain, limited physical mobility, and non-healing leg and foot ulcers. According to the American Heart Association, approximately eight million people in the U.S. suffer from P.A.D.1
The DEFINITIVE AR study, led by Prof. Dr. med. Thomas Zeller of Herz-Zentrum Bad Krozingen, in Germany and Prof. Dr. med. Gunnar Tepe of Klinikum Rosenheim also in Germany, uses the SilverHawk(R) and TurboHawk(TM) Plaque Excision systems and the MEDRAD Interventional(R) Cotavance(R) peripheral paclitaxel-coated angioplasty catheter with Paccocath(R) Technology. The Cotavance device used in the study is the next generation catheter platform with an enhanced drug coating process, currently pending European regulatory review.2
“The amount and type of calcified plaque in a patient’s vessel can affect the absorption of anti-restenosis drugs,” said Prof. Dr. med. Zeller. “Treating the vessel with plaque excision and removing the calcium, prior to the application of the drug-coated balloon, may enhance its effect. If this proves to be the case, plaque excision followed by drug-coated balloons may become a key strategy for achieving long-term results when treating long, diffuse calcified plaque build-up in the leg.”
The DEFINITIVE AR study will evaluate the use of either the TurboHawk or SilverHawk Plaque Excision System followed by treatment with the Cotavance drug-coated balloon catheter versus treatment with the Cotavance device alone in P.A.D. patients.
“DEFINITIVE AR is the third study in the DEFINITIVE Trial series, generating clinical evidence to confirm the effectiveness of plaque excision with the TurboHawk/SilverHawk System,” said Joe Woody, President, Vascular Therapies, Covidien.”DEFINITIVE AR continues our commitment to improve clinical outcomes and further the use of plaque excision as a frontline therapy for P.A.D. patients.”