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 Low-Profile Amsel Occluder Device1. The Pre-Market Notification is the second 510(k) clearance2 received by the company for its family of Amsel Occluder Devices. The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
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 Low-Profile Amsel Occluder. The Low-Profile 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. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder is cleared for commercial distribution. This is another in a series of regulatory filings, while we continue the development of additional Amsel Occluder products.”
Previous Announcements
On November 28, 2016, Amsel Medical Corporation Announced Presentation of “A Novel Mechanical Closure Device for Left Atrial Appendage Orifice and Closure of Right Atrial Incision” at the International Conference for Innovations in Cardiovascular Systems (ICI) Meeting 2016 (Israel).
On October 27, 2015, Amsel Medical Corporation announced Filing of 2nd 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Amsel Occluder Device.
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 July 25, 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 in open general surgery procedures on tubular structures or 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.
Publications
Miller A, Lilach N, Botero-Anug A, Willenz U, and Miller R: Comparison of a Novel Secure Transfixing Blood Vessel Occluder with the Hemoclip in the Porcine Model. Journal of Surgical Research 2017;209: 211 – 219.
Miller A, Lilach N, Miller R. and Kabnick L: A Novel, Simple, and Secure, Percutaneous Vessel Occluder for the Treatment of Varicose Veins. J. Vasc Surg; Venous and Lymphatic Disease 2017;5:114-20.
L. Kabnick and A. Miller. Ultrasound-placed clips will make CHIVA more widely applicable. Vascular and Endovascular Challenges Update. BIBA Publishing. Ed. Roger M Greenhalgh 2016; 529-534.
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 | On February 2, 2015, Amsel Medical Corporation announced its first Clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Amsel Occluder Device. | |
| 3 | CDC/NCHS National Hospital Discharge Survey, 2010 | |
| 4 | Company Estimates |
