Medical device giant Medtronic (NYSE:MDT) made progress in a pair of below-the-knee vascular devices, announcing U.S. and international launch of the Amphirion Plus PTA catheter and closing enrollment in a clinical trail of its IN.PACT Amphirion drug-eluting balloons.
Both devices treat periphery artery disease, with the Amphirion Plus PTA indicated for treatment of narrowed or blocked leg arteries below the knee and the IN.PACT Amphirion drug-eluting balloon used to treat critical limb ischemia, a more serious form of PAD, according to a Medtronic press release.
Physicians in the U.S. and Europe have already begun using the new Amphirion Plus PTA catheter, which recently won FDA 510(k) clearance and CE Mark approval in the European Union, the company wrote.
The IN.PACT clinical trial closed enrollment of 357 patients across 13 sites, randomizing them to treatment with either the paclitaxel-eluting balloon or conventional balloon angioplasty, according to a press release. The company has not yet released the results of the trial, but plans to examine endpoints including wound healing and limb salvage rates.
The Amphirion devices are part of Medtronic’s Invatec Technologies, an Italian cardiovascular device maker which Medtronic acquired for $500 million in 2010 along with Fogazzi, Invatec’s corporate predecessor, and Krauth Cardiovascular, which distributes Invatec products in Germany.
The news joins other Medtronic product launches and clinical trial news in the last month, including last week’s announcement that the company’s diabetic-friendly Resolute Integrity stent, the 1st with approval for use in patients with diabetes, made its market debut in India, the country with the 2nd-largest population of diabetics.
MDT shares gained 1.6% today, trading at $44.72 as of about 1:45 p.m.
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