ATS Medical, Inc. (ATSI) recently announced that it has received FDA (Food and Drug Administration) clearance and already completed the first implant of its ATS Simulus Semi-Rigid Annuloplasty Band.
The Simulus Semi-Rigid Annuloplasty Band is the latest addition to the company’s portfolio of valve repair products. It was developed under the company’s collaboration with Genesee BioMedical.
Sometimes surgeons prefer the repair of a patient’s heart valve to its replacement, thereby necessitating the need of annuloplasty rings and bands. The Simulus Semi-Rigid Annuloplasty Band takes care of the natural movement of the mitral annulus during the cardiac cycle that allows for a more physiologic valve repair. This is a unique characteristic that helps in the treatment of both the aortic and mitral valves.
The first implant of the band was performed by Dr. Robert F. Hebeler, Jr. at Heart Hospital Baylor in Plano, Texas.
Minneapolis, MN-based ATS Medical develops, manufactures and markets medical devices needed for cardiovascular surgery. The company’s products have been used in more than 140,000 heart implants across 61 countries. ATS Medical‘s core product, ATS Open Pivot—a mechanical bileaflet heart valve—is used to treat heart valve failure.
Through partnership arrangements and acquisitions, the company operates on three synergistic platforms: Heart Valve Therapy comprised of mechanical heart valves, tissue heart valves and repair products; Surgical Arrhythmia Therapy comprised of CryoMaze cryotherapy products; and Surgical Tools & Accessories that include blood filtration products, and minimally invasive tools used in robotic valve surgery.
ATS Medical has market share of 19% and 14% in procedures performed and global revenues, respectively (Source: ATS Medical estimates). The company’s main competitor is St. Jude Medical, Inc. (STJ) which at present holds approximately 50% of the worldwide mechanical heart valve market. Others include Medtronic, Inc. (MDT), Carbomedics and Edwards Lifesciences (EW).
ATS Medical’s first quarter of fiscal 2009 results showed marked improvements in its top and bottom-lines. Gross margin growth was driven by lower cost mechanical heart valves that are manufactured in-house, and higher average selling prices (ASPs) in the U.S. market. As such, our recent report has a Hold recommendation for ATS Medical.
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