Covidien Releases Clinical Data Supporting Treatment, New Approach to Peripheral Arterial Disease


October 15, 2013
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October 15, 2013 — Covidien 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. These studies demonstrated 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.
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). 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 physicians are achieving better acute procedural success when treating patients with 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.
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