Spectranetics wins 510(k) clearance for laser atherectomy cath

Spectranetics (NSDQ:SPNC) said yesterday it won FDA 510(k) clearance for its next-generation Turbo-Power laser atherectomy catheter for treating in-stent restenosis.

The Turbo-Power laser catheter treats at the tip and debulks lesions in a single step with remote automatic rotation for accurate directional control, the Colorado Springs, Colo.-based company said.

“Patients with ISR present the most challenging real-world cases, with the longest, toughest lesions, among those suffering with peripheral arterial disease. Turbo-Power, with its eccentric tip design, allows far more effective debulking of ISR lesions and I am optimistic the tool will further improve outcomes for patients. The device is backed by Level 1 clinical data proving both safety and efficacy at six months. With proven evidence, Turbo-Power will clearly drive practice adoption and set a new standard of care in ISR treatment,” New Cardiovascular Horizons chair Dr. Craig Walker said in a press release.

Results from the 318-patient Excite ISR trial examining patients being treated for femoropopliteal artery in-stent restinosis showed a 5.4% rate of major adverse events with the device compared to 20.8% compared to balloon angioplasty alone. The study also reported a 78.3% rate of freedom from target lesion revascularization through 6 months compared to 58.9% with PTA alone.

“With a relentless focus on improving patient care, Spectranetics is pleased to bring Turbo-Power, the next-generation in-stent restenosis treatment solution, to market, providing physicians and their patients a new standard of care they seek and deserve. As the only company with a FemPop in-stent restenosis indication, backed by Level 1 clinical evidence, and primary competitors contraindicated or not indicated, we are well positioned to deliver tools that advance care for patients suffering from peripheral arterial disease,” COO Shar Matin said in prepared remarks.

In April, Spectranetics touted 2-year data, published in the journal Catheterization & Cardiovascular Interventions, on the Stellarex the drug-eluting balloon it bought from Covidien early this year.

Data from the 78-patient Illumenate 1st-in-human study showed primary patency rates of 89.5% at 1 year and 80.3% at 2 years, Spectranetics said. The rate of freedom from clinically driven target lesion revascularization was 90.0% after a year and 85.8% at 24 months, according to the company.

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