CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amsel Medical Corporation today announced clearance of a Pre-Marketing Notification (510(k)) by the US Food and Drug Administration (FDA) for its Amsel Occluder Device1. 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.”
About Hillel Laks, MD
Hillel Laks, MD, is currently Chancellor's Professor of Surgery, UCLA Medical Center. Dr. Laks previously held the positions of Professor and Chief, Cardiothoracic Surgery, UCLA Medical Center, Los Angeles, California, Associate Professor, Director of Pediatric Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut, and Assistant Professor of Surgery, St. Louis University School of Medicine, St. Louis, Missouri. Dr. Laks has authored more than 100 peer-reviewed publications. He received his degree in medicine in 1965 with honors from Witwatersrand Medical School, Johannesburg, South Africa.
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.
About the Amsel Occluder Device
The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries) as well as tubular structures during open surgical procedures. 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. The Amsel Occluder Device employs a proprietary mechanical design that enables a vessel clamp to be introduced during open surgery. The Amsel Occluder Device transfixes the target vessel with the clamp to provide closure.
About Amsel Medical Corporation
Amsel Medical Corporation, a development stage medical device company, founded in 2011, is developing The Amsel Occluder Device is intended for simple and secure vessel or duct closure. The company has operations in Cambridge, MA, and Tel Aviv, Israel. The Amsel Occluder Device addresses an estimated 31 million3,4 annual US surgical procedures where vessel closure is required.
1 Patents pending
2 Dr. Laks is a member of the Amsel Medical Corporation Clinical Advisory Board
3 CDC/NCHS National Hospital Discharge Survey, 2010
4 Company Estimates