The US Food and Drug Administration (FDA) has granted clearance for Italy-based medical device firm Sorin Group's Memo 3D ReChord, a semi-rigid annuloplasty ring for mitral valve repair.
The new Memo 3D ReChord integrates a new chordal guide system into the existing Memo 3D ring to simplify and standardise the approach to artificial chord replacement.
The design of the semi-rigid annuloplasty ring streamlines mitral repair procedures while allowing surgeons to obtain reproducible results even in advanced chordal reconstructions.
University of Michigan Health System cardiac surgery professor Steven Bolling said: "The Memo 3D ReChord is simple-to-use with a minimal learning curve for new users.
"The chordal guide system gives surgeons more confidence when performing anterior mitral leaflet repairs with Gore-Tex chordae.
"I believe that using the Memo 3D ReChord allows surgeons to deliver more reproducible results during this procedure, ultimately improving patient outcomes.
"Offering a solution that standardises artificial chord replacement may actually increase the number of anterior mitral leaflet repairs performed each year."
The Memo 3D ReChord features the firm's exclusive Carbofilm coating to improve haemo-compatibility, and an advanced cell-structure design to accommodate the mitral saddle shape while enabling the physiological 3D motion of the native annulus.
Sorin Group cardiac surgery business unit president Michel Darnaud said: "The Memo 3D ReChord implant performed by prof Bolling and his team represents the first step in strategically growing our presence in the US mitral valve repair market.
"The most gratifying aspect of this first US experience is to see Sorin's technology deliver on the company's commitment to increase product standards for physicians while improving patient outcomes."
The company develops and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders.