FDA Clears Occluder Device from Amsel Medical

The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Amsel Medical Corp. for its Amsel Occluder Device, which is a device intended for use on tubular structures or blood vessels wherever a metal ligating clip is indicated and within the size range of 2 to 7 millimeters in diameter. The company submitted the technology for clearance in May.

The device employs a proprietary mechanical design that enables a vessel clamp to be introduced during open surgery. It transfixes the target vessel with the clamp to provide closure.

According to figures cited by the company, ehe Amsel Occluder Device addresses an estimated 31 million annual U.S. surgical procedures where vessel closure is required.

“It is exciting to see new vessel ligation technology enter the clinic,” said Hillel Laks, M.D., chancellor’s professor of surgery, UCLA Medical Center, in Los Angeles, Calif. “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 a secure suture ligature, which will prevent loosening or slippage. I look forward to seeing the Amsel Occluder enter clinical practice.”

Laks is a member of the company’s clinical advisory board.

Arnold Miller, M.D., founder and president of Amsel Medical said the FDA clearance “thrilled” him and that the company anticipates “significant clinical interest,” adding that this is the first in a series of regulatory filings, while the company continues developing “several additional Amsel Occluder products.”

Amsel Medical is a development-stage medical device company founded in 2011. The company has operations in Cambridge, Mass., and Tel Aviv, Israel.