According to the American Heart Association, approximately 10 million people in the U.S. are affected by PAD, which is one of the most common vascular diseases and can lead to heart attack, stroke, amputation and death. It occurs when arteries in the legs become narrowed or blocked by plaque; these blockages can result in severe pain for patients, limited physical mobility and non-healing leg ulcers."DEFINITIVE LE confirmed equivalent outcomes between diabetics and non-diabetics in terms of patency and persistent clinical improvement up to 12 months after treatment,” said Prof. Thomas Zeller, M.D., Head of the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad Kronzingen, Bad Krozingen, Germany. “Because diabetics have more advanced PAD, re-stenose faster and are more difficult to treat than non-diabetics, it is critical to preserve future treatment options in this patient population. The confirmation from DEFINITIVE LE of directional atherectomy as a treatment modality that provides strong clinical outcomes in diabetics is a welcome and practice-changing finding.” Dr. Garcia and Prof. Zeller, together with Dr. James McKinsey, Chief of the Division of Vascular Surgery and Endovascular Interventions at New York-Presbyterian Hospital/Columbia University Medical Center, served as Co-Principal Investigators for the DEFINITIVE LE study. DEFINITIVE LE Study Design The prospective, multi-center study comprised two cohorts—those with claudication and those with CLI. A total of 1,022 lesions (up to 20 cm in length) were treated with the Covidien SilverHawk or TurboHawk Plaque Excision device. The study included a broad patient population, with 52% diabetic, 45% female and 75% claudicants, and a pre-specified sub-analysis comparing patency outcomes in diabetic and non-diabetic patients. Several controls were included to ensure rigor in the study. These included Steering Committee oversight, adverse event adjudication by an independent physician Clinical Events Committee and endpoint analyses conducted by two different independent core laboratories—one that analyzed acute angiographic results and another that analyzed duplex ultrasound follow-up.
"We are pleased with the long-term results from our groundbreaking DEFINITIVE LE study, which is unique among atherectomy studies conducted to date because of the size of the study and the clinical rigor of execution,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “We are continuing to invest in the DEFINITIVE clinical program around new innovative treatments as a reflection of our commitment to partnering with medical professionals to deliver the best treatment for patients suffering with PAD.”Final results from the landmark study were presented today during the Late-Breaking Clinical Trials session at the Vascular InterVentional Advances ( VIVA) Conference here. 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 2011 revenues of $11.6 billion, Covidien has 43,000 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. Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50437214&lang=en