Massachusetts medical device giant Covidien (NYSE:COV) released results from a pair of studies, supporting use of the company’s EverFlex self-expanding stent and combining directional atherectomy with drug-coated balloons in treatment of patient with peripheral artery disease.
The company says its findings suggest a "new approach" to treating limb blockages in patients with PAD, a condition that affects more than 200 million patients around the world.
Covidien released final 3-year results from the DURABILITY II clinical trial of its EverFlex stent, which the company said demonstrated low rates of revascularization and fracture, findings which "support the long-term safety and effectiveness of the EverFlex stent in a challenging PAD patient population."
The DURABILITY II study was the 1st of its kind to examine single-stent treatment of long, complex lesions, enrolling 287 patients under an FDA investigational device exemption. Study results showed a 3-year fracture rate of 0.9% and 60% freedom of loss of primary patency, according to posted results.
The device maker provided an update on its DEFINITIVE AR trial, early results from which suggest better acute results for patients treated with directional atherectomy plus anti-restenotic therapy, compared with patients treated with drug-coated balloons alone.
The DEFINITIVE AR trial includes 121 patients enrolled at 10 centers in Europe, with researchers reporting 89.6% technical success rate, compared with 64.2% success with drug-coated balloons alone.