Updated on 17 May 2012
Japan PMDA approves Sorin heart ring
Singapore: Sorin Group received authorization from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to market its MEMO 3D Semi-Rigid Annuloplasty Ring. The first MEMO 3D implant was performed at the Kobe City Medical Center General Hospital.
Annuloplasty rings are indicated for repair of the mitral valve and are designed to remodel the anatomical shape of the heart's mitral annulus, thus preventing further dilatation and minimizing the risk of late repair failures.
The ring has an innovative cell-structure design, which is capable of mimicking the physiological three-dimensional motility of the native mitral annulus and accommodating the anatomical saddle shape. It boasts of a shape memory and super-elastic alloy core, aimed at restoring the native shape and function. The ring also features Sorin's exclusive Carbofilm coating for enhanced hemo-compatibility and has suture placement guides, a low profile holder and a special configuration of the silicon filler for ease of implant.
Dr Okada who successfully performed the first procedure of mitral valve repair with MEMO 3D at the Kobe City Medical Center General Hospital stated, "Due to its semi-rigid design and Carbofilm coating, MEMO 3D is expected to provide continuous physiological motion of the mitral annulus after mitral valve repair."
Professor Fischlein from Klinikum Nürnberg, Nuremberg, Germany, who implanted over 100 MEMO 3D rings reported: "We had the privilege of implanting this semi-rigid ring for the first time in man. The MEMO 3D ring capability to preserve mitral annulus flexibility has been confirmed by our magnetic resonance images, obtained after more than five years post-implantation, the longest follow-up period ever reported. We recommend using a complete annuloplasty ring to mimic the physiological three-dimensional motion of the native mitral annulus and preserve the sphincter mechanism of the valve."