Valcare Medical Receives IDE Approval for EFS of Amend Transseptal System

March 17, 2025—Valcare Medical Inc. recently announced that the FDA has approved the company’s investigational device exemption (IDE) application for the early feasibility study (EFS) of the Amend transseptal system for the treatment of mitral insufficiency. The company noted that the Amend device features a semirigid, closed, D-shaped annuloplasty ring that mimics the current gold standard of surgical treatment.

According to Valcare, the EFS will evaluate the safety and functionality of the Amend system in the treatment of patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (MR) who are anatomically suitable for transcatheter mitral annuloplasty.

The company stated that the primary and secondary endpoints of the EFS include safety and device performance assessments such as the technical success of ring delivery, implantation, and delivery system retrieval. Patient outcomes such as stroke, myocardial infarction, nonelective cardiovascular surgery for device-related complications, and all-cause mortality will be reported at 30 days and 6 months postimplantation.

Additional secondary endpoints will include changes in New York Heart Association functional class, 6-minute walk test, quality of life at 30 days and 6 months, and reduction of MR grade from baseline by at least one grade at 30 days, 6 months, and 1 year, noted the press release.

The study will enroll up to 15 patients at 7 centers in the United States and is expected to begin treating patients in the first half of 2025. A pivotal study is anticipated to begin in 2027, advised Valcare.

Scott Lim, MD, serves as Study Chairman of the AMEND EFS. Dr. Lim is Professor of Medicine & Pediatrics at the University of British Columbia in Vancouver, Canada, and Professor Emeritus at the University of Virginia in Charlottesville, Virginia.

“I am pleased and eager to begin the Amend transseptal system EFS to further evaluate this promising novel technology,” commented Dr. Lim in Valcare’s press release. “The Amend annuloplasty ring has the potential to improve mitral repair for a patient population that is considered poor candidates for currently available therapies. Furthermore, the Amend system provides a noninvasive approach to the gold-standard surgical repair, and I am excited for its potential to treat patients suffering from severe MR.”