Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system.
The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%.
The newly cleared device features a lower profile and longer length than the standard Pantheris, and is indicated for diagnosing and treating peripheral artery disease in small vessels between 2mm and 4mm.
“We are excited to receive U.S. pre-marketing clearance for Pantheris SV, which we believe could expand our addressable market for atherectomy procedures by as much as 50%. With the clearance of this new device, we are well-positioned to build on the positive momentum we have seen in our Pantheris business since the introduction of the next-generation system in 2018. Following our anticipated limited launch of Pantheris SV, we plan on leveraging our growing commercial infrastructure and installed base of Lumivascular accounts to efficiently scale up the introduction of Pantheris SV and drive growth of our Pantheris product family in the second half of 2019,” prez & CEO Jeff Soinski said in a press release.
The company said that it is planning to initiate a limited launch of the Pantheris SV at several U.S. sites, and that it expects distribution to expand as it builds product inventory and gains additional clinical experience.
“This product line extension represents a significant advancement for patients with PAD, in particular those suffering from the complications of small vessel disease. Treating small vessels presents a number of challenges and physicians have had a limited set of minimally invasive tools that can provide safe and effective outcomes for this high-risk patient population. Pantheris SV uses a combination of directional atherectomy with onboard image-guidance to provide several potential clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and precise vessel measurement capabilities,” chief medical officer Dr. Jaafer Golzar said in a preapred statement.
Avinger said that the Pantheris SV won CE Mark approval in the European Union last October. The company submitted an FDA application for approval for the Pantheris SV last August.
