Avinger Commences Limited Launch of the Pantheris SV in the United States

July 29, 2019—Avinger, Inc. announced the commencement of a limited launch of its Pantheris SV image-guided atherectomy system for small vessels. The launch will include 13 leading clinical centers before commercial distribution to additional treatment facilities in the United States. Physicians at four sites have treated several patients with the device.

According to Avinger, the Pantheris SV is an extension of the company's onboard catheter-based intravascular system for the diagnosis and treatment of peripheral artery disease. The new device increases the number of procedures that can be addressed with the Avinger's Lumivascular technology by targeting more distal regions of the vasculature in small diameter vessels. Lumivascular technology allows physicians to see inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography that is displayed on Avinger’s proprietary Lightbox console.

The device features a 140-cm catheter length and a smaller 6-F profile and incorporates key improvements introduced to the platform with the next-generation Pantheris catheter in May 2018.

Pantheris SV received European CE Mark approval in October 2018, which was followed by the first patients treated in Germany. Additional design improvements have been incorporated into the United States limited launch version of the technology, which are also expected to be introduced into the European market later this year.

Edward Pavillard, DO, a vascular surgeon at PA Vascular Institute in King of Prussia, Pennsylvania, performed the first Pantheris SV case in the United States. In the company's announcement, Dr. Pavillard commented, “Pantheris SV’s onboard image-guidance highlighted the eccentric nature of the disease and allowed me to target just the removal of the plaque while leaving minimal residual stenosis without adjunctive therapy. This technology is the only atherectomy device that I would feel safe using in this type of disease, and having a live image was key to the success of the procedure. The patient had brisk blood flow postintervention, zero complications in a critical area of the vasculature, and the whole procedure was completed without the use of contrast and with minimal fluoroscopy time.”