Covidien claims its DEFINITIVE LE study into use of two of its plaque excision systems in lower extremity surgery in final 12-month results demonstrates long term effectiveness of the devices.
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.
DEFINITIVE LE stands for Determination of Effectiveness of SilverHawk™ / TurboHawk™ Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities. It is the largest peripheral atherectomy study conducted to date with independent physician review of the outcomes. The study, which enrolled 800 patients at 47 centers in the U.S. and Europe, demonstrated the long-term effectiveness of directional atherectomy as a frontline therapy for the treatment of peripheral arterial disease (PAD). Directional atherectomy is a minimally invasive treatment that removes plaque from the body and restores blood flow in the native artery.
“For the first time, the DEFINITIVE LE study has provided robust evidence within a large and diverse PAD patient population,” said Lawrence A. Garcia, M.D., Chief of Interventional Cardiology and Vascular Interventions at St. Elizabeth’s Medical Center in Boston. “Directional atherectomy, with the SilverHawk and TurboHawk devices, delivers patency results at 12 months post-treatment that are comparable to those reported in stent studies—and with the important advantage of not leaving anything behind in the vessel.”
“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 study.
“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.”
Source: Covidien, Business Wire