Valcare’s AMEND TS EU Pilot Study Enrolls First Patients

May 28, 2024—Valcare Medical, Inc. recently announced the enrollment of the first two patient in the AMEND TS European Union (EU) pilot study of the company’s Amend transseptal system for mitral repair. Interventional cardiologist Bruno Melica, MD, and the team at the Hospital of Vila Nova de Gaia, Portugal, performed the study’s initial two procedures.

According to the company, the AMEND TS EU pilot study will evaluate the safety and performance of the Amend transseptal device as the primary technique in a comprehensive mitral repair approach comprising mitral annuloplasty as a standalone therapy or in combination with additional approved technologies to achieve a surgical-level repair.

The study will enroll 20 patients in several European sites. Each patient will be followed for a period of 12 months. After completion of the EU pilot study, Valcare plans to continue working with the FDA in the United States on a future investigational device exemption submission.

The company stated that the study is intended to build upon the positive results from the first-in-human experience in which 33 patients were successfully treated with the device. Valcare’s Amend mitral valve repair device is a closed, D-shaped, semi-rigid annuloplasty ring with anchoring capabilities.

“We are thrilled to have successfully implanted the Amend annuloplasty ring in the initial two patients enrolled in the AMEND TS EU pilot study,” commented Dr. Melica in Valcare’s press release. “These procedures mark a significant advancement in addressing an unmet need for patients at high risk for mitral valve surgery.”