Avinger Receives CE Marking Approval for Pantheris SV

Avinger Inc., a developer of treatments for peripheral artery disease (PAD), announced Conformité Européenne (CE) Marking approval of Pantheris SV (Small Vessel), a product line extension of the Lumivascular atherectomy system. CE Marking allows for distribution of Pantheris SV in the European Union (EU) and certain other countries that recognize the CE Marking. Pantheris SV is not available commercially in the United States at this time.
 
Designed with a lower profile and longer length, Pantheris SV is intended to expand the addressable market for Pantheris by allowing physicians to treat lesions in smaller diameter vessels (2 to 4 millimeters) and more distal regions of the vasculature. Pantheris SV incorporates key improvements from the next generation Pantheris launched in the U.S. market in June 2018, including a stiffer shaft for increased pushability, a refined OCT imaging system, and an enhanced cutter design.
 
”We believe that Pantheris SV represents a substantial market expansion opportunity for our technology, and having CE Marking for the device represents an important first step towards broader commercialization,” commented Jeff Soinski, Avinger’ president and CEO. ”The longer length and smaller profile of this new device should increase the number of lesions available for treatment by Pantheris, and we believe the safety profile enabled by our image-guidance system should enhance the confidence of physicians applying directional atherectomy to smaller vessels.”
 
Dr. Jaafer Golzar, Avinger’ chief medical officer, noted, ”Pantheris SV represents an important new option for physicians to treat small vessel disease. Given the potential consequences of an adverse event during peripheral interventions in this challenging area of the vasculature, a device with a high safety profile is of paramount importance. With real-time OCT visualization, we believe physicians will have the information they need to safely perform an intervention while maximizing the size of the channel restoring blood flow to the extremities, which should lead to better outcomes for patients with small vessel disease. We are excited to initiate our first clinical experiences with Pantheris SV in Europe in the near future.”
 
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger’ proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
 
Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). PAD is estimated to affect over 12 million people in the United States and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris family of atherectomy devices. Avinger is based in Redwood City, Calif.