Spectranetics next-gen laser atherectomy catheter receives FDA approval

Spectranetics (Colorado Springs, CO) has received FDA clearance for its Turbo-Power laser atherectomy catheter to treat in-stent restenosis (ISR). Laser atherectomy is driving a new standard of care for in-stent restenosis (ISR) treatment with improved clinical outcomes.

Uniquely designed to optimize ISR treatment, the company's Turbo-Power laser atherectomy catheter treats at the tip with vaporizing technology for maximal luminal gain. The device debulks the lesion in a single step and offers remote automatic rotation for precise directional control.

The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (arteries above the knee) In-Stent Restenosis (EXCITE ISR) is a large multicenter, prospective randomized trial ever conducted for the treatment of FemPop ISR. Durable results show that the company's laser atherectomy devices used with PTA (also known as balloon angioplasty) are safer and more effective than PTA alone for treating FemPop ISR based on two key data findings:

  • Primary safety endpoint, major adverse events (MAEs) rates at 30 days 5.4% vs. 20.8% with PTA alone (p<0.001).
  • Primary efficacy endpoint, freedom from target lesion revascularization (TLR) through six months 78.3% vs. 58.9% with PTA alone (p=0.002).

In July 2014, the company received FDA indication of its peripheral atherectomy products, Turbo-Tandem and Turbo-Elite, to treat ISR. Its next-generation Turbo-Power laser atherectomy catheter is optimized to treat ISR and capitalize on the original indication, expanding the company's portfolio to cross, prep, and treat the most complex cardiovascular conditions.

For more information, please visit www.spectranetics.com.

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