(NYSE:COV), a leading global provider of healthcare products, today announced final 12-month results from its
(Determination of Effectiveness of SilverHawk™ / TurboHawk™ Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities) study.
DEFINITIVE LE study confirms that directional atherectomy with Covidien's TurboHawk(TM) device is an effective frontline therapy when treating PAD in diabetic and non-diabetic patients (Photo: Business Wire)
DEFINITIVE LE 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 12-Month Efficacy and Safety Results
Clinical outcomes were improved by 30 days and sustained through 12 months of follow-up. Directional atherectomy with the SilverHawk and TurboHawk devices delivered 12-month patency results that were comparable to those reported in stent studies.
Among patients with claudication, primary patency (i.e., the treated artery remained open) was 78% using a peak systolic velocity ratio (PSVR) < 2.4 at 12 months. Notably, this rate did not differ between patients with diabetes (77%) and those without diabetes (78%)—the first such results to be shown in a prospective, powered analysis. Among patients with critical limb ischemia (CLI - a severe form of PAD), 95% were able to avoid a major unplanned amputation of the target limb. The SilverHawk and TurboHawk devices were shown to have a strong safety profile in the study, with low complication rates.