Valcare Medical's AMEND Transcatheter Mitral Annuloplasty Ring Receives FDA IDE Approval to Initiate Early Feasibility Study

Mar 15, 2025 22:15 CST Updated 22:15

Valcare Medical

Minimally Invasive Cardiac Valve Treatment Device Developer

Valcare MedicalAnnouncing itsTranscatheter Mitral Annuloplasty---AMENDReceived FDA approval for the IDE study and initiated the Early Feasibility Study (EFS).

The EFS study will evaluate the safety and efficacy of AMEND in treating patients with moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who meet the anatomical criteria for transcatheter mitral valve repair. The study plans to enroll up to 15 participants across seven centers in the United States, with patient treatment expected to commence in the first half of 2025, laying the groundwork for a pivotal study planned for 2027.

The primary and secondary endpoints of the study include device safety and performance evaluation, such as the technical success rate of annuloplasty ring delivery, implantation, and retrieval of the delivery system. Clinical endpoints, including stroke, myocardial infarction, unplanned cardiovascular surgeries due to device-related complications, and all-cause mortality, will be reported at 30 days and 6 months post-procedure.

Other secondary endpoints include improvements in NYHA functional class, 6-minute walk test, quality of life scores, and a reduction of at least one grade in mitral regurgitation severity from baseline at 30 days, 6 months, and 1 year post-procedure.

PI Evaluation

"The AMEND annuloplasty ring brings new hope for improving mitral valve repair to patient populations currently lacking effective treatment options. This system achieves the 'gold standard' repair effect of traditional surgery in a minimally invasive manner, offering significant clinical value for treating severe mitral regurgitation."

---Scott Lim University of British Columbia

"FDA Approval to Initiate EFS Study Marks a Key Milestone for Valcare Medical Towards Pre-Market Approval in the U.S. The study will build on data from the AMEND First-in-Human study, with results set to be unveiled as a late-breaking clinical trial at the CRT conference in Washington next month."

---Steve Sandweg CEO of Valcare Medical

AMEND

AMENDIt is a D-shaped semi-rigid closed ring with a unique anchoring method. The design of AMEND aims to achieve clinical outcomes consistent with the gold standard surgical annuloplasty ring through safer and simpler catheter-based procedures.AMENDIt can also be part of the Valcare mitral valve replacement system and tricuspid valve repair solutions.

AMEND Allowing preservation of the original valve anatomy and function, and can beImplantationNo need for the heart to stop beating during the surgery.

AMENDAdvantages:

Durable anchor design maintains the integrity of the mitral valve's physiological structure and provides long-term effectiveness.
Universal ring design, compatible with various implantation methods, such as transseptal, transatrial, and transapical.
Easy to useWith a unique anchoring system, the surgical time is shortened.
Good tissue compatibility, allowing for faster endothelialization
It can be used as an independent solution or in combination with edge-to-edge or chordal reconstruction.
It can also be combined with mitral valve replacement as the base of the mitral valve.

AMEND In Vitro Demonstration

Valcare Medical

Valcare MedicalIt is a private medical device company dedicated to providing innovative transcatheter technologies for the treatment of mitral and tricuspid regurgitation.Valcare MedicalStrive to make its developed medical devices an indispensable part of every structural heart surgery.