Amsel Medical Announces Filing Of 2nd 510(K) Pre-Marketing Notification With The US Food And Drug Administration For The Amsel Occluder Device

The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amsel Medical Corporation today announced that it has successfully completed filing of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Amsel Occluder Device^1,2 extending the indications of the Amsel Occluder Device to include a percutaneous route of administration. The company is seeking the following indications statement: “The Amsel Occluder Device is intended for use in open general surgery procedures or in percutaneous procedures when clinically indicated, on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm.”

“The Amsel Occluder Device is intended for use in open general surgery procedures or in percutaneous procedures when clinically indicated, on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm.”

Uri Rimon, Director of Interventional Radiology, Sheba Medical Center, Tel Hashomer Hospital, Israel, commented, “The precision and control for vessel closure afforded by the Amsel Vessel Occluder represents a fresh approach to facilitating accurate, complete and secure vessel closure. The Amsel Occluder Device provides a secure method for transfixing a tubular structure, such as a blood vessel. I look forward to the clinical use of the Amsel Vessel Occluder once it receives FDA pre-market clearance.”

Arnold Miller, MD, Founder and President of Amsel Medical Corporation commented, “We are thrilled to expand the Amsel portfolio of occlusion technologies with the filing of our second Pre-Marketing Notification (510(k)) with FDA. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder Device will be cleared for commercial distribution. This is the second in a series of regulatory filings, while we continue the development of several additional Amsel Occluder products.”

About Uri Rimon, MD

Uri Rimon, MD, is Director of the Department of Diagnostic Radiology, Chaim Sheba Medical Center, Tel-Hashomer, Israel and is on the faculty of the Sackler School of Medicine, Tel-Aviv University. Dr. Rimon earned his degree in medicine in 1986 from Ben Gurion University in Beer-Sheva, Israel and gained his postgraduate education with Fellowships in interventional radiology at Mount Sinai Hospital and NYU Medical Center in New York. He is author of over 40 peer-reviewed articles and publications.

Prior Announcements

On February 2, 2015, Amsel Medical Corporation announced Clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Amsel Occluder Device.

On May 20, 2014, Amsel Medical Corporation announced Filing of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the 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 hollow ducts) during surgical procedures. The cleared indications for use is:

“The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.” The currently cleared Amsel Occluder Device employs a proprietary mechanical design that enables a vessel clamp to be introduced during open surgery. The current 510(k) is to add the percutaneous route of administration to the product’s labeling. 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. The company has operations in Cambridge, MA, and Tel Aviv, Israel. The Amsel Occluder Device addresses an estimated 31 million^3,4 annual US surgical procedures where vessel closure is required.

¹ Patents pending

² Amsel Medical Corporation received FDA Pre-Market clearance on January 23, 2015 for the Amsel Occluder for open surgical applications of tubular structures or blood vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

³ CDC/NCHS National Hospital Discharge Survey, 2010

⁴ Company Estimates

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