CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amsel Medical Corporation today announced the company will present initial animal results of the Amsel Occluder1,2 in Left Atrial Appendage Orifice and Closure of Right Atrial Incision during the upcoming International Conference for Innovations in Cardiovascular Systems (ICI) Meeting 2016 (December 4-6, 2016 Israel).
Hillel Laks, M.D.3, co-investigator and Chancellor's Professor of Surgery, UCLA Medical Center, commented, "I am excited to participate in the development of new and innovative methods necessary to achieve effective left atrial appendage orifice closure. The clinical need for LAA closure is enormous and new technologies capable of achieving LAA closure in a growing patient population requiring this procedure is driving innovation. The Amsel Occluder possesses the ability to transfix and approximate selected tissues, advancing our technique beyond the current limitations of standard suture closure and current mechanical closure devices. The Amsel Occluder not only provides secure and hemostatic closure of the fragile atrial tissue but also allows mechanical closure of non-linear suture lines, eliminating residual pockets and recesses where clot can accumulate and embolize. I look forward to seeing the Amsel Occluder enter clinical practice."
About Hillel Laks, M.D.
Hillel Laks, M.D., 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 200 peer-reviewed publications. He received his degree in medicine in 1965 with honors from Witwatersrand Medical School, Johannesburg, South Africa.
About Atrial Fibrillation (AF) and Left Atrial Appendage (LAA) Closure
Analysts expect the global left atrial appendage (LAA) closure market to exceed $936 million by 2020, growing at a CAGR of over 28%. The market is expected to grow at a fast pace during the forecast period because of the growing elderly population and an increasing incidence of atrial fibrillation (AF) and strokes. Clinical evidence supporting the efficiency of left atrial appendage (LAA) closure devices compared to the standard therapeutic treatment such as warfarin and dabigatran in the treatment of AF and stroke is expected to boost the market growth.4 Atrial fibrillation is a common cause of cardiac embolic events, especially stroke. Oral anticoagulation therapy is used to reduce these events. Many patients however are unable to take such therapy. Occlusion of the left atrial appendage is an option in these patients and does not require anticoagulation other than low-dose aspirin. 5 Post-mortem and trans-esophageal echo studies have shown that approximately 90% of all cardiac thrombi originate from the left atrial appendage (LAA) in patients with AF.6 Surgical exclusion of the LAA at the time of mitral valve surgery or CABG has been shown to reduce the incidence of cardiac embolic events in patients with AF.7 AF affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently increasing the risk of stroke due to the migration of clots formed in the LAA.8
About the International Conference for Innovations in Cardiovascular Systems (ICI) Meeting 2016
ICI Meeting 20169 – the premier International Conference for Innovations in Cardiovascular Systems (Heart, Brain and Peripheral Vessels) and High-Tech Life Science Industry, will be held in Israel, December 4-6, 2016. The ICI Meeting is an acclaimed forum that aims to explore, fuel, and spark innovations that will shape the future of cardiovascular systems and beyond. Over the last two decades, Israel has become a medical “start-up nation.” ICI’s dynamic environment which allows rich exchanges on innovations has contributed to this process by facilitating global interaction between physicians, entrepreneurs, academia and industry and by building bridges leading to innovation.
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 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 million10,11 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 Dr. Laks is a member of the Amsel Medical Corporation Clinical Advisory Board
5 Cardiovasc J Afr. 2013 Jun; 24(4): 107–109
6 Acta Med Scand. 1969 May; 185(5):373-9
7 Ann Thorac Surg. 1996 Feb; 61(2):755-9
10 CDC/NCHS National Hospital Discharge Survey, 2010
11 Company Estimates