MiCardia Receives FDA Market Clearance for Annuloplasty Devices

The FDA has granted 510(k) clearance for MiCardia’s Dynaplasty Annuloplasty Band DR and Annuloplasty Ring DR. Heart valve annuloplasty bands are used for remodeling the fibrous tissue at the base of the valve, the annulus, while rings are implanted around the base to help maintain the natural shape, motion and flexibility. Dynaplasty technology provides a reduced-risk alternative for mitral valve regurgitation patients through intra-operative percutaneous or completely non-invasive mitral valve optimization, the company says.