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Amsel Medical Announces Filing Of A 510(K) Pre-Marketing Notification With The FDA For The Amsel Occluder Device

5/20/2014 7:30:27 AM

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Amsel Medical Corporation Announces Filing of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Amsel Occluder Device

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 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.

Thomas O'Donnell, MD2, 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.”

About Thomas O’Donnell Jr., MD

Thomas O’Donnell Jr., is a Senior Vascular Surgeon at Tufts Medical Center and the Benjamin Andrews Professor of Surgery (Emeritus at Tufts University School of Medicine). Dr. O'Donnell has held a wide range of senior leadership positions at Tufts including Chairman of the Department of Surgery, and President and Chief Executive Officer. Over his distinguished career Dr. O'Donnell has developed a number of innovative treatments that have improved the outcomes for patients with Venous Disease. He has authored more than 160 peer-reviewed papers and 62 book chapters. He received his degree in medicine in 1967 cum laude from Tufts University School of Medicine, and completed a Vascular Fellowship at the Massachusetts General Hospital.

About Arnold Miller, MD

Arnold Miller, MD is Founder and President of Amsel Medical Corporation. He is a vascular surgeon and inventor with over 45 years experience in general and vascular surgery. He has held positions at the Beth Israel Deaconess Hospital, Boston, MA, Metrowest Medical Center, Natick, MA, and the Massachusetts General Hospital (MGH), Boston MA. Dr. Miller has conducted extensive basic research in early, non-invasive detection and quantification of atherosclerotic disease, involving phono-angiographic instrumentation, as well as clinical research that included the introduction of new technologies to improve patient care. He invented a number of technologies that were successfully commercialized, including an irrigation pump, multi-lumen irrigation catheter, and valvulotome for in-situ bypass procedures. These technologies enabled the development of the field of angioscopy for vascular surgery3,4. In aortic surgery he has patented and produced a spring fastener to secure aortic aneurysm endografts and a facilitating sheath for the delivery of vascular endografts. Dr. Miller has authored six issued patents, published over 46 peer-reviewed articles in top medical journals, and written over 20 book chapters. He has also run his own successful vascular clinic for over 20 years. He holds a FRCS (London), FRCS (Canada), FACS with fellowships in vascular surgery at the Massachusetts General Hospital, MA, and Methodist Hospital, TX.

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 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 that 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 million5,6 annual US surgical procedures where vessel closure is required.

1 Patents pending

2 Dr. O’Donnell is a member of the Amsel Medical Corporation Clinical Advisory Board

3 Arnold Miller and Juha P. Salenius. Angioscopy: Instrumentation, Techniques and Applications, in Peripheral Endovascular Interventions (3rd edition) ed., Rodney A. White and Thomas J. Fogarty, Mosby, St Louis, 2010

4 Miller A et al: Angioscopically directed valvulotomy: a new valvulotome and technique. Journal of Vascular Surgery 1991;13:813-821

5 CDC/NCHS National Hospital Discharge Survey, 2010

6 Company Estimates

Amsel Medical Corporation
Arnold Miller, 617-395-8825
Bill Edelman, 781-436-0509
Chairman of the Board

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