Mitral regurgitation, a condition where the mitral valve doesn't close properly, leads to blood leaking back into the heart, causing fatigue and shortness of breath. Traditional treatments often involve invasive surgery, which may not be suitable for high-risk patients or those with anatomical challenges. Existing transcatheter mitral valve replacement (TMVR) systems can be limited by the risk of left ventricular outflow tract obstruction and challenges related to mitral annular dimensions and calcification.

4C Medical Technologies offers the AltaValve™, a supra-annular TMVR system designed to treat mitral regurgitation in a broader range of patients. The AltaValve is implanted in the atrium above the mitral valve, preserving the native valve and critical cardiac structures. This supra-annular placement reduces the risk of left ventricular outflow tract obstruction, a common complication with other TMVR devices. The system is delivered via a minimally invasive transcatheter approach, reducing the need for open-heart surgery and potentially leading to faster recovery times.

Supra-annular valve placement to minimize left ventricular outflow tract obstruction

Self-expanding nitinol frame designed for secure anchoring in the left atrium

27-mm trileaflet bovine pericardium valve for optimal hemodynamics

Fabric skirt to prevent paravalvular leaks and promote tissue ingrowth

Transapical delivery system (32F) for precise valve placement

Repositionable and partially retrievable design for intra-procedural adjustments

Designed to accommodate a wide range of mitral annulus sizes and anatomies

Future transseptal delivery system in development

The primary target audience includes interventional cardiologists and cardiac surgeons treating patients with symptomatic mitral regurgitation who are at high risk for traditional open-heart surgery or are not candidates for mitral valve repair.