Amsel Medical announced clearance of a Pre-Marketing Notification (510(k)) by the US Food and Drug Administration (FDA) for its Amsel Occluder Device.
The Amsel Occluder Device is intended for use on tubular structures or blood vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Hillel Laks, MD2, Chancellor’s Professor of Surgery, UCLA Medical Center, commented, "It is exciting to see new vessel ligation technology enter the clinic.
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."
Arnold Miller, MD, Founder and President of Amsel Medical Corporation commented, "We are thrilled about the clearance of the Pre-Market Notification (510(k)) by FDA for the Amsel Occluder.
"We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder will be cleared for commercial distribution. This is the first in a series of regulatory filings, while we continue the development of several additional Amsel Occluder products."
On July 28, 2014, Amsel Medical Corporation and the Mayo Clinic Announced Signing of a Patent License Agreement
On May 20, 2014, Amsel Medical Corporation announced that it had successfully completed filing of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Amsel Occluder Device.