Avinger (Redwood City, Calif.) recently received FDA clearance for its Pantheris image guided altherectomy device that is designed to treat peripheral artery disease (PAD).
Pantheris is the first medical device to be cleared for diagnostics and treatment of PAD. The device lets doctors see inside arteries to treat blockages. It features a built-in camera and can shave plaque without causing damage to blood vessels.
The device can also be used by physicians to use the real-time intravascular imaging tool to identify features of blood vessels, include necrotic cores, fibroatheromas, calcium and stent struts.
When used with Avinger’s Lumivascular Platform technology, the Pantheris catheter can guide doctors with optical coherence tomography (OCT) imaging while they continue to treat PAD lesions. Before the technology, physicians had to use X-ray images to steer tools during a procedure.
In May, Avinger won FDA 510(k) clearance for the device, which features a simpler, single-balloon system that is designed for apposition and blood flow occlusion with improved push ability and tissue storage capacity.
The approval comes shortly after the company priced an upcoming offering worth $3.6 million. Avinger said it was looking to sell approximately 2.2 million shares of common stock at $1.64 per share to hopefully bring in $3.6 million. It also plans to offer warrants for the purchase of half a share of common stock for each share purchased with an exercise price of $1.58 per share.
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