September 10, 2008
MiCardia Wins FDA Approval for Dynaplasty Annuloplasty Devices
MiCardia, which develops implantable devices for the treatment of heart disease, has announced that the FDA has granted 510(k) marketing clearance for its Dynaplasty Annuloplasty Band DR and Annuloplasty Ring DR.
These are said to be MiCardia's first Dynaplasty technology products to receive clearance. MiCardia is developing the Dynaplasty technology for the percutaneous and non-invasive treatment of structural heart disease including mitral valve regurgitation, tricuspid valve regurgitation and congestive heart failure.
According to the company, Dynaplasty technology provides devices that can be implanted into the heart and then dynamically adjusted either during a procedure or post-operatively for the proper shape and size to produce the optimal clinical outcome both at the time of the procedure or at subsequent post-operative intervals.
Paul Molloy, CEO of Micardia, said: "This is a key regulatory milestone for MiCardia which involved extensive technical validation of the company's first generation annuloplasty system. It prepares the way for the progression of Dynaplasty technology and pairs with the commencement of the company's Dyana Phase I human study in Europe."