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.

Follow us on Twitter, 'like' us on Facebook, connect with us on Google+, and join our group on LinkedIn

Get All the BioOptics World News Delivered to Your Inbox

Subscribe to BioOptics World Magazine or email newsletter today at no cost and receive the latest news and information.

 Subscribe Now
Related Articles

Merz acquires laser tattoo removal device maker ON Light Sciences

Merz North America has acquired ON Light Sciences, which develops technologies to enhance laser-based dermatology procedures.

Shortwave-infrared device could improve ear infection diagnosis

An otoscope-like device that could improve ear infection diagnosis uses shortwave-infrared light instead of visible light.

Laser therapy extracts rare tumor that grew human hair, skin in boy's skull

About four years ago, a tumor comprised of human skin, hair, bone and cartilage was fast-growing inside a Ramsey, MN, 10-year-old youth's brain.

Low-level laser therapy could speed muscle recovery at Rio 2016 Olympics

The gold medal-winning women’s U.S. Gymnastics team is reportedly experimenting with infrared light therapy to alleviate pain and reduce swelling in its athletes. (Update: A spokesperson for ...

Neuro15 exhibitors meet exacting demands: Part 2

Increasingly, neuroscientists are working with researchers in disciplines such as chemistry and p...

Why be free?

A successful career contributed to keeping OpticalRayTracer—an optical design software program—fr...

LASER Munich 2015 is bio-bent

LASER World of Photonics 2015 included the European Conferences on Biomedical Optics among its si...

White Papers

Understanding Optical Filters

Optical filters can be used to attenuate or enhance an image, transmit or reflect specific wavele...

How can I find the right digital camera for my microscopy application?

Nowadays, image processing is found in a wide range of optical microscopy applications. Examples ...



Twitter- BioOptics World