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. 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.
Thomas O'Donnell, MD, Senior Vascular Surgeon at Tufts Medical Center (Boston) commented, "Ligation techniques and technology for internal vessels has remained unchanged for many decades. As a clinician, I am always aware of the potential for ligating clips to become dislodged following placement, leading to a host of complications, both during the surgical procedure and thereafter. The Amsel Occluder Device represents a fresh approach to facilitating accurate, complete and secure vessel closure. The Amsel Occluder Device provides a minimally invasive method for transfixing a tubular structure, such as a blood vessel, and provides security, similar to a suture ligation performed through an open technique. I am excited to see the Amsel Occluder Device enter clinical practice once it receives FDA pre-market clearance."
Arnold Miller, MD, Founder and President of Amsel Medical Corporation commented, "We are thrilled to have filed the first Pre-Marketing Notification (510(k)) with FDA for the Amsel Occluder Device. 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 first in a series of regulatory filings, while we continue the development of several additional Amsel Occluder products."
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