Avinger Seeks 510(k) Clearance for Pantheris SV Lumivascular Device

August 30, 2018—Avinger, Inc. announced the submission of an application to the FDA for 510(k) clearance of the Pantheris SV (small vessel) Lumivascular atherectomy system. The device is an extension of the company's Pantheris family of image-guided atherectomy catheters for the treatment of peripheral artery disease.

According to the company, the Pantheris SV is designed with a lower profile and longer length for treating lesions in smaller diameter vessels and more distal regions of the vasculature. The Pantheris SV incorporates key improvements introduced to the platform with the clearance of the next-generation Pantheris system that was announced in May 2018. Improvements include a stiffer shaft for increased pushability, a refined optical coherence tomography imaging system, a more robust nosecone, and an enhanced cutter design.

On August 29, Avinger announced the issuance of a United States patent (No. 10,052,125), “Atherectomy Catheter With Laterally-Displaceable Tip,” for the Pantheris system. The patent describes an atherectomy catheter including real-time image guidance using optical coherence tomography, a displaceable tip, and a balloon to urge the catheter’s cutting element into the tissue to be removed. These are all key features of the Pantheris atherectomy system, noted the company.