FDA Clearance and First U.S. Implant of Sorin’s Memo 3D ReChord Annuloplasty Ring

Italian Cardiovascular device company, Sorin has gained U.S. FDA clearance for Memo 3D ReChord™, an innovative semi-rigid annuloplasty ring for mitral valve repair.

Background

As recently as October 2014 we reported the CE marking and first European use of Sorin’s new Memo 3D ReChord. Now the U.S. FDA has cleared it for sale and a first U.S. implant has been performed.

Sorin Group’s latest innovation in mitral valve repair, 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 unique design streamlines 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 exclusive Carbofilm™ coating to enhance hemo-compatibility
  • Innovative cell-structure design to accommodate the mitral saddle shape while enabling the physiological 3D motion of the native annulus.

Physician comments

Steven F. Bolling, M.D., Professor of Cardiac Surgery, University of Michigan Health System, Ann Arbor, MI who conducted the first implantation of the ring in the United States, commented on his experience: “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 standardizes artificial chord replacement may actually increase the number of anterior mitral leaflet repairs performed each year.”

Company comments

“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,” said Michel Darnaud, President Cardiac Surgery Business Unit, Sorin Group. “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.”

Source: Sorin Group, Business Wire

 

Share your thoughts

Your email address will not be published. Required fields are marked *