Avinger, based in Redwood City, California, just announced receiving FDA clearance for its next generation Pantheris Lumivascular atherectomy system. The product simultaneously provides intravascular imaging to allow surgeons to see the site of the disease and a tool to remove the built up plaque from within the targeted vessel.
According to the company, the latest iteration of the Pantheris devices includes “a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a reinforced nosecone with the option for more tissue storage capacity, and an enhanced cutter design.”
“The Pantheris Lumivascular atherectomy system has allowed me to treat peripheral artery disease with more precision while largely avoiding trauma to the blood vessel during an intervention,” in a published statement said Dr. Barry Tedder, M.D., Interventional Cardiologist at St. Bernards Medical Center in Jonesboro, Arkansas. “Unlike some other products, this technology’s performance can stand on its own but also enhance other forms of adjunctive therapy if needed, while preserving future treatment options for the patient. As one of the first users of the initial generations of Pantheris, I have been eagerly awaiting the product enhancements incorporated into the new system, which has the promise of not only improving ease of use, but also providing a new level of operator control during the procedure.”
The new device already has European approval and has been used by German intravascular surgeons for a few months already.
Medgadget flashbacks: Real-Time Intravascular Imaging for PAD by Avinger: Interview with CEO Jeff Soinski…; Avinger Ocelot Catheter with Optical Coherence Tomography Cleared by FDA for PAD…; Avinger’s New Pantheris OCT Image Guided Atherectomy Device Cleared by FDA…; Avinger’s Wildcat Catheter for Crossing Chronic Total Occlusions in PAD…
Product page: Pantheris…
Via: Avinger…