Positive final data for EverFlex (Covidien) in PAD

Covidien has released positive final results from its DURABILITY II study and promising preliminary data from its DEFINITIVE AR trial of the EverFlex Self-expanding stent, for treating Peripheral Artery Disease (PAD). 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). 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 and no �bailout� stents required.

Results were presented at the Vascular Interventional Advances (VIVA) 2013 conference. The EverFlex was FDA approved in March 2012 and was CE mark approved in January 2013 with the Entrust delivery system.