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ATS Medical semi-rigid valve repair device cleared by FDA

This article was originally published in The Gray Sheet

Executive Summary

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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