The FDA has given 510(k) clearance to Spectranetics’ Turbo-Tandem and Turbo Elite peripheral atherectomy devices for the treatment of in-stent restenosis, the company said Wednesday.
Clinical results from the randomized EXCITE study showed higher safety and efficacy among patients treated for femoropopliteal in-stent restenosis with laser atherectomy plus percutaneous transluminal angioplasty compared with PTA alone. The procedural success rate along laser-treated patients was 94 percent versus 83 percent in the control arm.
Spectranetics said the devices will help to improve clinical outcomes and overall ISR treatment while giving the company the only indicated devices in a $350 million domestic and $750 million global market.
U.S. rollout of the device will begin in August, Guy Childs, Spectranetics’ chief financial officer, told Device Daily Bulletin. Sales teams will begin training next week.
The Turbo-Tandem and Turbo Elite devices are both CE-marked, Childs noted, adding the company is interested in expanding into emerging ISR markets as well. — Kellen Owings
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