The Pantheris small vessel (SV) device extends the company’s line of Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller-diameter vessels and more distal regions of the vasculature.
Pantheris SV incorporates improvements introduced to the platform with the clearance of the next-generation Pantheris system in May 2018, including a stiffer shaft for increased pushability, a refined OCT imaging system, a more robust nosecone, and an enhanced cutter design. The FDA approved the original Pantheris system in 2015. The device has a built-in camera that allows doctors to see inside arteries and shave plaque without damaging blood vessels.
“Effective tools to address lesions in smaller vessels represent an important unmet clinical need in the treatment paradigm for PAD,” said Dr. Jaafer Golzar, Avinger’s chief medical officer, in a prepared statement. “There is a lack of long-term durability noted with other treatment options in this area of the vasculature. However, the concept of pairing onboard image-guidance with a directional atherectomy system could provide a number of significant clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and a potential enhancement in the uptake of anti-restenotic drug therapy.”
Avinger (Redwood City, Calif.) hopes to begin marketing Pantheris SV in the U.S. by early 2019.