Covidien (NYSE: COV), a leading global provider of healthcare products, has released positive final results from its DURABILITY II study and promising preliminary data from its DEFINITIVE AR trial at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas, NV. These studies demonstrate the safety and effectiveness of technologies used in the treatment of peripheral arterial disease (PAD). The DURABILITY II three-year results support the use of a single long EverFlex™ self-expanding stent. DEFINITIVE AR acute 30-day data shows early success with the combined use of directional atherectomy and a drug-coated balloon (DAART) in treating lower limb blockages in PAD patients.
The DEFINITIVE AR study evaluated the use of directional atherectomy with Covidien's TurboHawk(TM) plaque excision system. (Photo: Business Wire)
“Covidien’s extensive clinical research program in vascular therapies aims to provide rigorous evidence that physicians can use to make treatment decisions for conditions, such as peripheral arterial disease – a common vascular disease affecting over 200 million people worldwide,” said Mark Turco, M.D., Chief Medical Officer, Covidien Vascular Therapies. “Providing clinically relevant data – like the DURABILITY II and DEFINITIVE AR trials - to physicians is a must, and I’m proud of Covidien’s work to drive this evidence.”
In DURABILITY II, the use of the EverFlex™ stent demonstrated a low need for repeat procedures (revascularization of treated lesions) as well as a low rate of stent breakage (fracture rate). Stent fracture is a known cause of artery reblockage leading to repeat procedures. Final results support the long-term safety and effectiveness of the EverFlex stent in a challenging PAD patient population.
In the DEFINITIVE AR randomized study, early results show that physicians are achieving better acute procedural success when treating patients with directional atherectomy plus anti-restenotic therapy (DAART) versus using a drug-coated balloon alone. The results also showed superior lumen gain with DAART treatment with fewer vessel tears (dissections) and no “bailout” stents required.