Covidien plc (NYSE:COV) said it has enough patients to evaluate the effectiveness of an arterial plaque removal system it acquired in its buyout of ev3 Inc. last year.
The Mansfield, Mass.-based company completed enrollment for an 800-patient study of the SilverHawk atherectomy system. The device is designed to cut away plaque lining the peripheral arteries in the legs and feet. The study, Definitive LE, aims to evaluate whether treated arteries remained unobstructed in patients with claudication (or difficulty and pain walking or standing) and whether doctors could save the limbs of patients with critical limb ischemia a year after treatment.
The Definitive LE study is the largest ever post-market peripheral arterial disease device study, according to Covidien, with 47 centers in both the U.S. and Europe participating.
"This trial is large enough to provide excellent comparisons to all major trials currently available and understand how this approach works within a large but diverse patient population," St. Elizabeth’s Medical Center interventional cardiology chief Dr. Lawrence Garcia said in prepared remarks. Garcia is the study’s principle investigator.
Covidien acquired the SilverHawk product family when it bought out Minnesota-based vascular treatment device maker ev3 Inc. for $2.6 billion last July.
The post Covidien closes enrollment on ev3 atherectomy device study appeared first on MassDevice.