Healthcare Industry News:  peripheral artery disease 

Devices Interventional FDA

 News Release - December 18, 2012

Avinger Receives FDA Clearance for Ocelot / PIXL

New smaller, longer catheter gives physicians more options for saving legs

REDWOOD CITY, Calif.--(Healthcare Sales & Marketing Network)--Avinger Inc., a medical device manufacturer of innovative, multi-functional imaging catheters for crossing chronic total occlusions (CTOs) in patients with peripheral artery disease (PAD), has received FDA clearance to market Ocelot / PIXL in the United States. Just one month after receiving clearance to commercially sell the Ocelot System in the US, the first-ever CTO crossing device with onboard imaging, Avinger debuts its newest member of the Ocelot family.

“With its smaller profile and longer length, Ocelot / PIXL is designed to bring all the benefits of Ocelot to help physicians treat more patients with smaller arteries,” said John B. Simpson PhD, MD, Avinger Founder and CEO. “Because Ocelot / PIXL, like the original Ocelot catheter, uses real-time intravascular imaging via optical coherence tomography (OCT), I’m confident more legs will be saved, and more patients will walk home happy.”

Using Ocelot / PIXL, physicians can now navigate lesions with a choice between 135cm or 150cm working length. With its 5 French sheath compatibility and reinforced distal coil for precise steerability, Ocelot / PIXL goes the extra distance with ease, providing intravascular imaging at all times. Like all Ocelot catheters, Ocelot / PIXL is supported by Avinger’s Lightbox console.

More about the Ocelot Family

The Ocelot family of catheters, supported by the Lightbox console, allows physicians to see from inside an artery during the actual procedure using directional OCT. In the past, operators have had to rely solely on x-ray as well as touch and/or feel to guide catheters through complicated blockages. With Ocelot, physicians can more accurately navigate through CTOs thanks to the images from inside the artery.

To learn more about PAD, visit http://avinger.com/pad.

To learn more about the Ocelot System and patient stories, visit http://avinger.com/ocelot or email sales@avinger.com.

About Avinger

Founded in 2007 by renowned cardiologist and medical device entrepreneur Dr. John B. Simpson, Avinger develops next-generation catheter-based technologies for the treatment of peripheral artery disease (PAD). Leveraging core competencies in medical device catheter engineering and intravascular Optical Coherence Tomography (OCT), Avinger globally markets Ocelot, the first ever real-time directional OCT crossing catheter, in addition to its Wildcat and Kittycat catheters. www.avinger.com.


Source: Avinger

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