JenaValve Technology, Inc.

JenaValve Technology, Inc. is a cardiovascular medical device company specializing in transcatheter aortic valve replacement (TAVR) systems. The company manufactures the Trilogy® Transcatheter Heart Valve System, the first and only FDA-approved TAVR device specifically indicated for the treatment of severe, symptomatic native aortic regurgitation (AR) in high-risk surgical patients. The Trilogy system features proprietary locator technology that aligns with native aortic anatomy, a self-expanding nitinol frame with large, open cell design to preserve coronary access, porcine pericardial tissue treated with proprietary Jasmine® tissue treatment, and a sealing ring for anchoring and conformity to the left ventricular outflow tract (LVOT). The integrated delivery system includes a pre-shaped, hydrophilically-coated 85 cm introducer sheath, catheter deflection mechanism for valve centering, and integrated rotation for precise commissural alignment. Clinical evidence from the ALIGN-AR pivotal study (n=700) and CAP study demonstrates 95.0% technical success, 1.3% valve embolization, and 1.0% moderate aortic regurgitation at 1 year—substantially superior outcomes to off-label TAVR alternatives. The device is indicated for symptomatic, severe tricuspid aortic valve regurgitation in patients at high or greater surgical risk (STS score ≥8% predicted 30-day mortality). Implantation requires physician training through JenaValve's Professional Education program and must be performed in centers capable of emergency cardiac surgery. The company provides reimbursement support, clinical evidence resources, and patient education through affiliated platforms.