ATS Medical, Inc. (ATSI) has received approval from the U.S. Food and Drug Administration (FDA) for a landmark clinical study in which cardiac surgeons will implant the company’s ATS 3f Aortic Bioprosthesis valve in a younger aortic valve replacement patient population. The clinical study will be performed to evaluate the effectiveness of ATS 3f Aortic Bioprosthesis valve in a younger population, those less than 60 years of age.
The ATS 3f is a tissue valve that functions like a natural valve. It has the same tube shape that helps in maintaining a steady blood flow at a normal speed. Valves are subject to natural wear and tear. The 3f valve is used for replacing a valve in the aorta, the largest blood vessel in the body.
ATS Medical is looking forward to the clinical test results. Positive test results will boost demand for this product, which will eventually drive the company’s top-line.
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. The company also operates in the tissue valve market. ATS Medical’s main competitor is St. Jude Medical, Inc. (STJ). Other competitors include Medtronic, Inc. (MDT), Carbomedics and Edwards Lifesciences (EW).
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