FDA Clears Memo 3D Annuloplasty Ring
September 25, 2007 - The Sorin Group, a European cardiovascular company, announced today that it has received FDA clearance for marketing its MEMO 3D Semirigid Annuloplasty Ring in the U.S., targeting patients receiving mitral valve repair as therapy for mitral valve disease.
Annuloplasty rings are indicated for repair of the mitral valve and are designed to remodel the anatomical shape of the mitral annulus, preventing further dilatation and minimizing the risk of late repair failures.
Its core structure reportedly enables the MEMO 3D ring to restore the natural mitral annulus’ three-dimensional motility during the cardiac cycle.
The MEMO 3D Semirigid Annuloplasty Ring has a cell-structure design, capable of mimicking the physiological three-dimensional motility of the native mitral annulus and accommodating the anatomical saddle shape. The shape memory and super-elastic alloy core is aimed at restoring the native shape and function. Carbofilm coating reportedly enhances hemo-compatibility. The suture placement guides, a low profile holder and a special configuration of the silicon filler, is designed for ease of implant.
The MEMO 3D annuloplasty ring has already been introduced in several European countries. CarboMedics Inc., Sorin Group’s U.S. subsidiary, will distribute MEMO 3D in the U.S.
For more information: www.sorin.com