Technology | Annuloplasty Rings | June 15, 2018

LivaNova Receives FDA Clearance for Memo 4D Semi-Rigid Mitral Annuloplasty Ring

Company also announces first implantation of next-generation device

LivaNova Receives FDA Clearance for Memo 4D Semi-Rigid Mitral Annuloplasty Ring

June 15, 2018 — LivaNova PLC announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring. The company also confirmed the first implantation of the device.

Memo 4D, LivaNova’s next-generation of the Memo device family, now offers a broader range of ring sizes from 24 to 42mm, allowing an additional patient population with mitral regurgitation (MR) to be treated. Memo 4D is the only annuloplasty ring on market to offer the 42mm size, according to LivaNova1. Larger size rings facilitate repair in the presence of severe degenerative MR like Barlow’s disease or enlarged annuli.

Additional features of Memo 4D include:

  • ReChord chordal guide system accelerates procedure times, while providing a standardized approach to neochordae implantation;
  • New ring design offers improved dimensions to treat enlarged annuli and reduce the risk of systolic anterior motion (SAM);
  • True semi-rigid stability and flexibility to ensure a natural behavior; and
  • Gradual saddle shape optimizes the physiological geometry in enlarged annuli.

The first Memo 4D implant was performed by Sreekumar Subramanian, M.D., FACS, of TriStar Cardiovascular Surgery at TriStar Centennial Medical Center in Nashville.

“Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets,” said Subramanian. “The new larger sizes allow us to treat more patients and pathologies while providing the potential to further improve patient outcomes. With Memo 4D, surgeons can optimize mitral repair procedures rather than replacing the entire mitral valve.”

For more information:


1. Measures correspond to intercommissural distance.

Related Content

Boston Scientific Exercises Option to Acquire Millipede Inc.
News | Annuloplasty Rings | January 02, 2019
Boston Scientific Corp. exercised its option to acquire the remaining shares of Millipede Inc, a privately-held company...
Second Micro Interventional Devices Annuloplasty System Successfully Implanted
News | Annuloplasty Rings | October 30, 2017
Micro Interventional Devices Inc. (MID) recently announced the second successful implantation of its MIA (Minimally...
HAART 300 Aortic Annuloplasty Device Sees U.S. Pilot Launch, First Commercial Use
News | Annuloplasty Rings | July 05, 2017
July 5, 2017 — BioStable Science & Engineering Inc.
TITAN II Trial, Carillon Mitral Contour System, Cardiac Dimensions, Open Heart journal, functional mitral regurgitation, FMR
News | Annuloplasty Rings | July 20, 2016
New data from the TITAN II trial confirm the safety and efficacy of the Carillon Mitral Contour System in the treatment...
Mitralign Percutaneous Annuloplasty System, MPAS, CE Mark approval
News | Annuloplasty Rings | April 27, 2016
Mitralign Inc. announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its...
Carillon mitral contour system, Cardiac Dimensions, functional mitral regurgitation, FMR, University Hospital Liepzig study
News | Annuloplasty Rings | February 24, 2016
A single-center study noted that treatment with Cardiac Dimensions’ Carillon Mitral Contour System resulted in...
Carillon mitral contour system, cost-effective, optimal medical treatment, OMT, TITAN, functional mitral regurgitation, FMR

Carillon mitral contour system image courtesy of Cardiac Dimensions Inc.

News | Annuloplasty Rings | September 10, 2015
The Carillon mitral contour system is projected to be a cost-effective treatment option when compared to a typical...