ATS Medical semi-rigid valve repair device cleared by FDA
This article was originally published in The Gray Sheet
Cardiac surgical device maker gains 510(k) clearance Oct. 23 for its ATS Simulus semi-rigid annuloplasty ring for mitral valve repair. The device was developed and marketed through a partnership with Genesee BioMedical. ATS estimates the market for valve repair devices at $100 million, with about 50% of procedures using semi-rigid devices. "The ease and reproducibility facilitated during implant" of our Simulus flexible rings and bands "has helped us rapidly carve out a significant niche within the minimally invasive and robotic valve market; one that we look to build upon and exceed with our semi-rigid product," said CEO Michael Dale. ATS awaits U.S. approval of its first tissue valve, the ATS 3F aortic bioprosthesis, and its AP360 mechanical heart valve
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