Valcare Medical Achieves Milestone with First U.S. AMEND™ Implant for Mitral Valve Repair

Valcare Medical Makes History with First AMEND™ Implant in the U.S.

Valcare Medical, a leader in the development of innovative solutions for mitral valve repair, recently announced a significant achievement in cardiac treatment—the first U.S. implantation of the AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System. This milestone was part of the AMEND TS Early Feasibility Study, demonstrating the company’s ongoing commitment to advancing less invasive medical procedures.

The landmark procedure took place at the Banner – University Medical Center in Phoenix, performed by the esteemed cardiologist Dr. Paul Sorajja. A recognized expert in the field of interventional cardiology, Dr. Sorajja acknowledged the importance of this new approach, stating, "For many patients with mitral regurgitation, open-heart surgery is either too risky or simply not an option due to age or other health conditions. The AMEND transseptal approach offers physicians a percutaneous alternative designed to deliver a surgical-style repair option for their patients, providing less pain, faster recovery, and the potential for excellent long-term outcomes."

The AMEND™ System introduces an innovative method of mitral valve repair through the delivery of a D-shaped, semi-rigid annuloplasty ring via catheter. This transseptal approach is designed to replicate the anatomical remodeling and clinical outcomes associated with traditional surgical techniques used in most open-heart mitral valve repairs. An essential aspect of the AMEND System is its ability to retain future treatment options, should patients require additional intervention down the line.

CEO of Valcare Medical, Steve Sandweg, emphasized the significance of this development, stating, "Annuloplasty has served as the foundation of over 95% of surgical mitral valve repairs for decades. Applying this proven surgical technique via a transcatheter approach represents a significant advancement in cardiac care. We’re grateful to Dr. Sorajja, Banner Health, and all involved for helping bring this important therapy closer to patients dealing with significant functional mitral regurgitation."

About the AMEND TS Early Feasibility Study

The AMEND TS Early Feasibility Study (EFS), registered under NCT06951672, is a prospective, single-arm clinical trial focusing on the safety and efficacy of the AMEND Transseptal System in patients experiencing symptomatic moderate to severe mitral regurgitation. The study will encompass a total of 15 patients across seven investigational sites throughout the United States.

Valcare Medical is dedicated to revolutionizing the approach to managing mitral regurgitation by providing transcatheter solutions that combine the effectiveness and reliability of surgical annuloplasty while mitigating the risks associated with traditional open-heart surgery. Their flagship product, the AMEND™ Transcatheter Mitral Valve Repair Annuloplasty System, aims to restore optimal mitral valve geometry and functionality through a minimally invasive route.

Founded in Wilmington, Delaware, Valcare Medical is committed to transforming cardiac care and ensuring that patients have access to the most advanced treatment options. As the company moves forward with its research and development, it continues to keep patient-centric care at the forefront of its mission.

Note: The Valcare AMEND System is currently an investigational device limited to research use only and not available for clinical sales. For more information about Valcare Medical and its innovative products, visit www.valcaremedical.com or connect on LinkedIn.