AngioDynamics Submits 510(K) Application For AlphaVac System


Minimally invasive medical devices provider AngioDynamic Inc has submitted a 510(K) application for its AlphaVac System to the U.S. Food and Drug Administration (FDA).

The Alphavac System is an off-circuit, multi-purpose mechanical aspiration thrombectomy device. It is designed to treat unwanted intravascular material in the venous system and peripheral vasculature.

AngioDynamics (ANGO) President and Chief Executive Officer, Jim Clemmer, said, “We are excited to announce this important milestone in the ongoing transformation of our portfolio. Our team developed AlphaVac in collaboration with leading physicians to enable treatment in more cases without the need for perfusion while providing control, power, and versatility to drive positive patient outcomes.”

Clemmer added, “AlphaVac expands our thrombus management portfolio allowing us to serve a larger, fast-growing segment of the thrombectomy market and we are confident it will become a go-to treatment option for physicians.” (See AngioDynamics stock analysis on TipRanks)

The AlphaVac System makes use of the company’s two proprietary technologies, including a mechanical aspiration handle and a self-expanding funnel tip. The system is designed to offer precise control during clot removal while also reducing blood loss.

Subject to regulatory clearance, the company expects to bring the system to market in 2H21.

On April 8, Raymond James analyst Jayson Bedford gave the stock a Buy rating but did not assign any price target.

After meetings with the company’s management, Bedford expects “the stock to rerate higher on increasing confidence in consensus estimates and the 510K filing for Angio’s new mechanical thrombectomy device that opens up a new market opportunity, with a long term tail.”

The other analyst covering the stock, Canaccord Genuity’s William Plovanic, has a Hold rating on the stock with a $24 price target (1% upside potential).

The two ratings add up to a Moderate Buy consensus rating, with an average analyst price target of $24. Shares have gained about 127% over the past year.

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