NEWS

WIRES

OTHER

Covidien Announces First Patient Enrollment in DEFINITIVE AR Study

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 and TurboHawk Plaque Excision systems and the MEDRAD Interventional Cotavance peripheral paclitaxel-coated angioplasty catheter with Paccocath 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."

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

¹ Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001;286:1317-1324.

² The Cotavance catheter is not approved or available for sale in the United States. Paccocath and Cotavance are registered trademarks of Bayer Schering Pharma AG.

Vascular Therapies
Rachel Bloom-Baglin, 508-261-6651
Vice President, Communications
rachel.bloombaglin@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Cole Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Todd Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com