Patients with peripheral artery disease fared better when treated using atherectomy and balloon angioplasty than with angioplasty alone, according to new clinical trial data from Covidien (NYSE:COV)
The 121-patient study, Definitive AR, compared the outcomes of patients who had their lesions treated by directional atherectomy followed by the insertion of a drug-eluting balloon, versus those treated with only a balloon.
According to Covidien, directional atherectomy uses a catheter with a uniquely designed directional cutter that allows physicians to maximize luminal gain by directing the cutter toward the lesions restricting blood flow in blood vessels. Lesions can also be removed by inserting balloons coated with a blockage-inhibiting drug such as paclitaxel.
"This small but rigorous pilot study suggests an added benefit for [directional atherectomy and anti-restenosis therapy] over [drug-coated balloon] in challenging lesions," vascular therapies chief medical officer Dr. Mark Turco said in prepared remarks. "Further investigation in larger, prospective, statistically-powered randomized trials is warranted to confirm the positive trends observed in Definitive AR and to evaluate a possible economic advantage to a DAART strategy. Covidien continues to invest in the Definitive AR study, and patients will be followed out to 24 months to assess the durability of the results."
Covidien said the study used its SilverHawk and TurboHawk directional atherectomy systems and Bayer’s paclitaxel-coated angioplasty catheter. The results were released this week at the Vascular Interventional Advances 2014 conference in Las Vegas.
Earlier this month, Covidien announced the FDA granted 510(k) clearance for the latest addition to its line of atherectomy devices, the HawkOne directional system for PAD. Last October, Covidien released results from a pair of studies supporting treatment of PAD with the EverFlex self-expanding stent combined with directional atherectomy and a drug-coated balloon.
Covidien is in the process of merging with fellow device maker Medtronic (NYSE:MDT) in a deal worth approximately $43 billion.