The US Food and Drug Administration (FDA) has cleared Caranx Medical’s TAVIPILOT Soft, an artificial intelligence (AI)-based guide software for use during Transcatheter Aortic Valve Implantation (TAVI) or replacement procedures (TAVR).
The French company claims that TAVIPILOT Soft is the first solution of its kind, designed to simplify heart valve positioning and delivery by tracking real-time anatomical and instrument landmarks during implantation or replacement.
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Caranx filed for TAVIPILOT Soft’s clearance with the FDA in January. The agency’s clearance for the software was based on a demonstration of the software’s feasibility during a live TAVI procedure on a porcine (pig) model. Caranx also filed a human factors engineering (HFE) validation by interventional cardiologists and cardiac surgeons at leading structural heart centres in Chicago and New York, and bench and simulation data in which Caranx demonstrated consistent valve-positioning accuracy of the software.
According to Caranx, the complexity of TAVI/TAVR procedures means their application is currently limited to the most advanced cardiology centres. With its AI software, which is compatible with all cardiac imaging systems and TAVI heart valves currently on the market, the company hopes to democratise access and allow a broader range of cardiologists and cardiology centres to undertake TAVI/TAVR procedures.
Caranx founder Philippe Pouletty said: “Allowing a broader number of cardiologists and interventional cardiology centres to perform complex procedures, such as TAVI, with the Caranx AI-driven software and autonomous robot is at the heart of our mission of entrepreneurs and business builders to save lives and revolutionise medicine.”
Caranx is targeting an early market launch of TAVIPILOT Soft in the US by the end of 2025.
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By GlobalDataAccording to GlobalData analysis, the global TAVR market is growing at a CAGR of 8.1% and projected to reach a valuation of almost $15bn by 2034.
Caranx CEO Jorgen Hansen commented: “This clearance confirms the potential of real-time guidance in TAVI and TAVR procedures to enhance precision and improve patient outcomes.”
TAVIPILOT Soft is currently fed by annotated images including computed tomography, fluoroscopy, echocardiograms from over 5,000 patients. Caranx said it plans to continue refining TAVIPILOT Soft in the future to cover other cardiovascular indications including mitral and tricuspid valve replacements.
To further develop TAVIPILOT Soft, Caranx added that it is looking into collaborating with other cardiovascular companies under the aegis of Carvolympics, a yearly accelerator and competition the company has created with the aim to crowdsource the next generation of AI-driven, robotic-assisted solutions across structural heart interventions.
