FDA News

FDA clears laser atherectomy catheter for in-stent restenosis

The FDA issued 510(k) clearance to Spectranetics for a peripheral laser atherectomy catheter for the treatment of in-stent restenosis, according to a company press release.

The Turbo-Power Laser Atherectomy Catheter treats at the tip with vaporizing technology for maximal luminal gain. The device debulks the lesion in one step and offers remote automatic rotation for directional control, according to the release.

The 510(k) clearance follows results of the multicenter, prospective EXCITE ISR trial, in which 252 patients with femoropopliteal in-stent restenosis were randomly assigned at a 2:1 ratio to receive percutaneous transluminal angioplasty (PTA) with laser atherectomy using the Turbo-Power laser atherectomy catheter (Spectranetics) or PTA alone. The primary efficacy endpoint was freedom from target lesion revascularization at 6 months and the primary safety endpoint was freedom from major adverse events at 30 days.

According to the release, the laser atherectomy arm exhibited “highly significant statistical superiority” for both primary endpoints compared with controls. Freedom from TLR at 6 months was observed in 78.3% of the atherectomy group vs. 58.9% of the PTA-only group (P = .002) and the incidence of major adverse events at 30 days was 5.4% and 20.8%, respectively (P < .001).

“Patients with [in-stent restenosis] present the most challenging real-world cases, with the longest, toughest lesions, among those suffering with peripheral arterial disease,” Craig Walker, MD, president and medical director of the Cardiovascular Institute of the South and clinical professor of medicine at Tulane University and Louisiana State University Medical Schools, said in the release. “Turbo-Power … allows far more effective debunking of [in-stent restenosis] lesions and I am optimistic the tool will further improve outcomes for patients.”

Disclosure: Walker is a stockholder of and reports serving as a consultant, on a speaker’s bureau and medical/scientific board for Spectranetics.

The FDA issued 510(k) clearance to Spectranetics for a peripheral laser atherectomy catheter for the treatment of in-stent restenosis, according to a company press release.

The Turbo-Power Laser Atherectomy Catheter treats at the tip with vaporizing technology for maximal luminal gain. The device debulks the lesion in one step and offers remote automatic rotation for directional control, according to the release.

The 510(k) clearance follows results of the multicenter, prospective EXCITE ISR trial, in which 252 patients with femoropopliteal in-stent restenosis were randomly assigned at a 2:1 ratio to receive percutaneous transluminal angioplasty (PTA) with laser atherectomy using the Turbo-Power laser atherectomy catheter (Spectranetics) or PTA alone. The primary efficacy endpoint was freedom from target lesion revascularization at 6 months and the primary safety endpoint was freedom from major adverse events at 30 days.

According to the release, the laser atherectomy arm exhibited “highly significant statistical superiority” for both primary endpoints compared with controls. Freedom from TLR at 6 months was observed in 78.3% of the atherectomy group vs. 58.9% of the PTA-only group (P = .002) and the incidence of major adverse events at 30 days was 5.4% and 20.8%, respectively (P < .001).

“Patients with [in-stent restenosis] present the most challenging real-world cases, with the longest, toughest lesions, among those suffering with peripheral arterial disease,” Craig Walker, MD, president and medical director of the Cardiovascular Institute of the South and clinical professor of medicine at Tulane University and Louisiana State University Medical Schools, said in the release. “Turbo-Power … allows far more effective debunking of [in-stent restenosis] lesions and I am optimistic the tool will further improve outcomes for patients.”

Disclosure: Walker is a stockholder of and reports serving as a consultant, on a speaker’s bureau and medical/scientific board for Spectranetics.