It may have taken 2 years but final results from Covidien’s (NYSE:COV) DEFINITIVE LE study finally appeared in the Journal of the American College of Cardiology’s Cardiovascular Interventions issue.
Originally announced in 2012, the results show that Covidien’s directional atherectomy devices are safe and effective in treating peripheral artery disease. Researchers used the company’s TurboHawk and SilverHawk systems to help save patients from amputation by removing plaque from blood vessels and keeping arteries open.
The 800-patient landmark study remains the largest of its kind conducted with independent, core lab analysis of outcomes, Covidien said. Researchers reportedly 95% limb salvage in patients with critical limb ischemia and 78% overall patency at 12 months.
"This further confirms the effectiveness and versatility of directional atherectomy in a wide range of vessel sizes and clinical presentations," co-global principal investigator Dr. James McKinsey said in prepared remarks. "Atherectomy is an important treatment option as the therapy leaves nothing behind in the body and preserves all future treatment options."
The study further concluded that the devices are safe to use in patients with diabetes in addition to vessel blockages. Peripheral artery diseases affects an estimated 1 in 3 diabetes patients, according to the researchers.