Amsel Medical wins FDA nod for Endo Occluder

Amsel Medical

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.

The post Amsel Medical wins FDA nod for Endo Occluder appeared first on MassDevice.

Amsel Medical touts 1st-in-human use of AOD2 occluder

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Amsel Medical

Development stage medical device firm Amsel Medical today 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.

The Cambridge, Mass. and Israel-based company said its AOD2 device was used during a variety of vascular surgical cases to ligate and occlude target vessels. Amsel said that the device met performance goals and that clinical reaction to its use was positive.

The Amsel AOD2 device is designed to securely close blood vessels and tubular structures during open surgical procedures, for use wherever a metal ligating clip is indicated within a size range of 2mm to 7mm in diameter. The device features a proprietary medical design to allow a vessel to be clamped during open surgery, the company said.

“We are thrilled to have reached first-in-man clinical use of the Amsel Occluder Device. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel, advancing our technique beyond the current limitations of standard ligation clips. This simply applied device is the equivalent of the secure suture ligature, which will prevent loosening or slippage. 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.

Amsel said it won FDA 510(k) clearance for its low-profile Amsel occluder device in September.