Avinger, a developer of Peripheral Artery Disease (PAD) diagnosis and treatment systems, has received 510(k) clearance from the US Food & Drug Administration (FDA) for its Pantheris Small Vessel (SV) image-guided atherectomy system.
Avinger said that Pantheris SV is an extension of its product line Lumivascular image-guided atherectomy platform.
The company anticipates Pantheris SV to expand the available market for Pantheris by up to 50%, addressing a larger portion of the estimated $500m atherectomy market.
Pantheris SV has been designed with a lower profile and longer length than Pantheris for the diagnosis and treatment of PAD in small vessels ranging from 2mm to 4mm in diameter.
It features key upgrades to the platform before the launch of the next-generation Pantheris system, including a stiffer shaft for increased pushability, a refined OCT imaging system, and an enhanced cutter design.
Avinger president and CEO Jeff Soinski said: “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.”
In October 2018, Pantheris SV has secured CE Marking and the first patients were treated with the device in November in Germany.
Avinger said that it is planning to initiate a limited launch of Pantheris SV in several sites in the US and the distribution of device is expected to be expanded along with the company gaining clinical experience, building product inventory, and receiving purchasing approvals in new Lumivascular sites.
Soinski added: “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.”
Lumivascular technology enables physicians to see from inside of the artery during an atherectomy procedure using an imaging modality called optical coherence tomography (OCT) that is displayed on Avinger’s proprietary Lightbox console.
Avinger chief medical officer Jaafer Golzar said: “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.”