U.S. FDA approves OCT image-guided atherectomy device for small vessel disease

Avinger (Redwood City, CA), which develops optical coherence tomography (OCT) image-guided, catheter-based systems for the diagnosis and treatment of patients with peripheral artery disease (PAD), has received U.S. FDA clearance for its Pantheris SV (Small Vessel) OCT image-guided atherectomy device.

Pantheris SV, a product line extension of Avinger's Lumivascular image-guided atherectomy platform that consists of the Lightbox imaging console, the Ocelot chronic total occlusion (CTO) catheters, and the Pantheris atherectomy devices, is expected to expand the available market for Pantheris by up to 50% and allow the company to address a larger portion of the estimated $500 million atherectomy market.

Pantheris SV is indicated for the diagnosis and treatment of PAD in small vessels (2–4 mm in diameter). It incorporates key improvements introduced to the platform with the launch of the next-generation Pantheris system in June 2018, including a stiffer shaft for increased pushability, a refined OCT imaging system, and an enhanced cutter design.

Pantheris SV received CE Mark approval in October 2018 and the first patients were treated with the device in Germany in November. The company intends to initiate a limited launch of Pantheris SV in several sites in the U.S. when commercial product is available. Distribution of Pantheris SV is expected to be expanded as the company gains additional clinical experience, builds product inventory, and receives purchasing approvals in new Lumivascular sites.

For more information, please visit avinger.com.