Amsel Medical said today that it won FDA 510(k) clearance for its Amsel Endo Occluder device intended for occluding blood vessels during endoscopic procedures.
The Cambridge, Mass.-based company touted that the clearance is the third the company has received from the FDA so far for its portfolio of occluder devices.
The Amsel Endo Occluder is a mechanical occlusion clip delivered through a fine needle intended to be deployed to transfix a target vessel while clamping it shut. The device is composed of an endoscopic litigating clip applier and clips which the company said are intended or use on tubular structures or vessels.
“We are thrilled to expand the Amsel Occluder family of single-use, site-specific vascular control devices into the endoscopic and minimally invasive surgery market with this recent Pre-Marketing Notification (510(k)) by the US Food and Drug Administration. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel or duct. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder device is cleared for commercial distribution,” founder & prez Dr. Arnold Miller said in a press release.
Last November, Amsel Medical touted the first-in-human clinical use of its Amsel AOD2 occluder device, which took place at the NYU Langone Medical Center in New York.