Valcare Medical Completes First US Implant in Study
Valcare Medical announced the first U.S. implant of its transseptal AMEND device as part of an early feasibility study. The procedure marks a step forward in the development of new medical devices. Such advancements rely on embedded systems for real-time control, sensor integration, and monitoring.
- The first U.S. procedure was performed by Dr. Paul Sorajja at Banner – University Medical Center in Phoenix. This marks a significant step for Valcare Medical, a privately held company based in Wilmington, Delaware. - This Early Feasibility Study (EFS) plans to enroll up to 15 patients at seven different investigational sites across the United States. The study's primary goals are to assess the safety and performance of the AMEND system, monitoring outcomes like stroke and mortality at 30 days and 6 months post-implant. - The AMEND device is a D-shaped, semi-rigid annuloplasty ring designed to replicate the results of traditional open-heart surgical mitral valve repair but delivered through a less invasive transseptal catheter approach. This method avoids open-heart surgery for patients who are considered high-risk. - A key feature of the AMEND system is its design to preserve future treatment options. This means that if a patient's mitral regurgitation recurs, they may still be eligible for other interventions like valve-in-ring therapy or edge-to-edge repair. - The FDA's EFS program allows for clinical investigation of devices early in their development with a smaller number of subjects to gather initial data on safety and functionality. This can help guide device modifications before larger, more definitive pivotal studies are conducted, with a pivotal study for the AMEND device anticipated in 2027. - Prior to the U.S. study, the AMEND device has been clinically evaluated in first-in-human and pilot studies in Canada, Europe, and Israel. A European pilot study for the AMEND TS system began with enrollments in Portugal and has since expanded to include sites in Italy. - Valcare Medical underwent a corporate restructuring in April 2024, appointing Steve Sandweg as CEO and Chris Richardson as Executive Board Chair to accelerate the AMEND clinical studies in the U.S. and Europe. Sandweg has a 25-year background in the medical device industry, including roles at Medtronic and EBR Systems.
