Covidien’s New Clinical Data is a Statement of Intent for its Peripheral Arterial Disease Business

Last week saw the Vascular InterVentional Advances (VIVA) 2013 conference taking place in Las Vegas, NV. At the event, Covidien released positive final results from its DURABILITY II study and promising preliminary data from its DEFINITIVE AR Peripheral Artery Disease (PAD) trial involving some of its technologies.


Covidien says the two studies demonstrate the safety and effectiveness of technologies used in the treatment of PAD. The DURABILITY II three-year results support the use of a single long EverFlex™ self-expanding stent. And 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 DURABILITY II study recorded the use of the EverFlex™ stent of various lengths, with 73% of patients receiving stents of over 10cm in length. Results demonstrated a low need for revascularization of treated lesions as well as a sub-1% rate of stent breakage, a known cause of artery reblockage leading to repeat procedures. 60% of stents were patent at 36 months leading investigators to support the long-term safety and effectiveness of the EverFlex stent in a challenging PAD patient population.

The DEFINITIVE AR study, presented by principal investigator Prof. Thomas Zeller, M.D, Universitaets-Herzzentrum Freiburg – Bad Krozingen, Germany, evaluated the use of directional atherectomy with Covidien’s TurboHawk(TM). Early results from this randomized study 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. In fact, restenosis of less than 30% was achieved in 90% of the treatment group at 30 days compared with under 65% of the balloon only group.

Company comments

“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.”

Source: Covidien, Business Wire