FDA Clears Avinger's Next-Generation Pantheris Lumivascular Atherectomy System

May 24, 2018—Avinger, Inc. announced that it has received 510(k) clearance from the US Food and Drug Administration for the company's next-generation Pantheris Lumivascular atherectomy system. The device combines real-time intravascular imaging with catheters for the treatment of peripheral artery disease. Lumivascular technology allows physicians to see from inside the artery during an atherectomy procedure by using optical coherence tomographic imaging that is displayed on Avinger’s Lightbox console.

In December 2017, Avinger announced that the new version of Pantheris received European CE Mark approval.

According to the company, design improvements of the next-generation device include a simplified single-balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a reinforced nose cone with the option for more tissue storage capacity, and an enhanced cutter design.

Avinger intends to launch two versions of the next-generation Pantheris (standard and extended length nose cone) at initial sites in the United States immediately. Distribution of the new device will be expanded as the company increases production and gains purchasing approvals in additional Lumivascular sites.

Additionally, the company plans to incorporate the new device into the INSIGHT investigational device exemption trial that is currently in progress. INSIGHT is a multicenter clinical study designed to evaluate the safety and effectiveness of Pantheris for treating in-stent restenosis in lower extremity arteries.

In Avinger's press release, Barry Tedder, MD, commented, “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. 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.” Dr. Tedder is an interventional cardiologist at St. Bernards Medical Center in Jonesboro, Arkansas.