Spectranetics president and CEO Scott Drake said: "FDA clearance of our peripheral atherectomy devices to treat ISR is a landmark moment for Spectranetics and patients worldwide.
"We are the only company with indicated devices, our primary competitors are contraindicated; we possess clinical data that will change clinical practice and a scaled commercial team to capitalize on this $750 million market opportunity."
The FDA has approved the Turbo-Tandem and Turbo Elite peripheral atherectomy products based on data from the EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (the arteries above and behind the knee) In-Stent Restenosis (EXCITE ISR) clinical trial.
EXCITE ISR, a multi-center, randomized prospective clinical trial, was initially designed to enroll a maximum of 318 subjects at up to 35 sites. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone.
The primary safety endpoint is freedom from major adverse events at 30 days, while the primary efficacy endpoint is freedom from TLR through six months.
Earlier 2014, Spectranetics announced early success of the trial based on achieving significant statistical superiority in both safety and efficacy among 250 patients.
The trial showed a 94% procedural success rate using laser atherectomy with PTA versus 83% with PTA alone.
