Sorin Gets FDA OK for Mitral Valve Repair Device

Italian cardiovascular company, Sorin Group, received U.S. Food and Drug Administration (FDA) clearance for Memo 3D ReChord, a semi-rigid annuloplasty ring for mitral valve repair.

The new Memo 3D ReChord incorporates an innovative chordal guide system into the existing Memo 3D ring to simplify and standardize the approach to artificial chord replacement. Memo 3D ReChord’s is designed to streamline mitral repair procedures while allowing surgeons to obtain reproducible results even in advanced chordal reconstructions.

Memo 3D ReChord‘s one-of-its-kind features include:
• A unique temporary chordal guide system that simplifies artificial chord replacement;
• Sorin’s Carbofilm coating to enhance hemo-compatibility; and
• Cell-structure designed to accommodate the mitral saddle shape while enabling the physiological 3-D motion of the native annulus.

“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,” said Steven F. Bolling, M.D., professor of cardiac surgery, University of Michigan Health System in Ann Arbor, who conducted the first implantation of the ring in the United States. “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 standardizes artificial chord replacement may actually increase the number of anterior mitral leaflet repairs performed each year.”

“The Memo 3D ReChord implant performed by Prof. Bolling and his team represents the first step in strategically growing our presence in the U.S. mitral valve repair market,” said Michel Darnaud, president of Sorin’s Cardiac Surgery Business Unit. “The most gratifying aspect of this first U.S. experience is to see Sorin’s technology deliver on the Company’s commitment to increase product standards for physicians while improving patient outcomes.”

Sorin Group develops medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3, 500 employees worldwide, Sorin Group focuses on two major therapeutic areas: cardiac surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement prostheses) and cardiac rhythm management (pacemakers, defibrillators and non invasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment).