Avinger (Redwood City, CA) has received FDA clearance for an enhanced version of the company's Pantheris lumivascular atherectomy system, an optical coherence tomography (OCT) image-guided atherectomy device for treating periphery artery disease (PAD). The company will begin marketing this enhanced version of Pantheris immediately, which features improved ergonomics, physician controls, and manufacturability.
Related: FDA-approved device sees inside occluded arteries causing PAD
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 utilized in the Pantheris system allows physicians to see from inside the artery during a directional atherectomy procedure by using OCT. In the past, physicians have had to rely solely on x-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease. With the lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the OCT images they see from inside the artery.
In the recently completed VISION study, 130 patients were treated with Pantheris and followed for a period of six months. The study achieved its primary safety and efficacy endpoints, and showed a target lesion revascularization rate of 8%. No single event of vessel perforation, clinically significant dissection, or late aneurysm resulted from using the system.
In October 2015, the company received FDA clearance for the Pantheris system for treating patients with PAD, and subsequently filed a second 510(k) application in December 2015 seeking clearance for the enhanced version of the system.
For more information, please visit www.avinger.com.