NICE, France — Caranx Medical, a French medical device company developing an autonomous robotic system to expand access to transcatheter aortic valve implantation (TAVI), has announced the first clinical use of its TAVIPILOT Soft software. The procedure was successfully performed at Clinique Pasteur in Toulouse, France, between October 20 and 22, 2025, by Dr. Didier Tchetche and his team as part of the SAITO-1A first-in-human study.
The study involved 10 patients with severe aortic stenosis undergoing TAVI via the transfemoral approach using an Edwards Sapien 3 valve. TAVIPILOT Soft performed without any technical issues in all procedures, autonomously identifying anatomical landmarks and accurately assessing implantation depth in real time. Comparative measurements between software predictions and the actual implanted valve positions selected by clinicians showed excellent accuracy. No procedural complications were reported, and investigator satisfaction was high, confirming the feasibility, safety, and technical robustness of TAVIPILOT Soft in TAVI procedures.
The successful first-in-human experience marks a critical milestone for Caranx as it prepares for a U.S. market introduction of TAVIPILOT Soft, expected by the end of 2025.
“Our first clinical use of the TAVIPILOT Soft is a major achievement for the Caranx team. This study confirms the potential of real-time guidance in TAVI/TAVR procedures to enhance precision and improve patient outcomes,” said Eric Sejor, M.D., Chief Medical Officer at Caranx. “We are excited to move forward with early commercialization and offer interventional teams a solution that can support safer and more predictable valve deployment.”
Despite two decades of TAVI technology, cardiologists continue to face challenges and long learning curves in ensuring precise valve delivery. While approximately 300,000 TAVI procedures are performed annually in the U.S. and Europe, an estimated 1.7 million patients are in need of the procedure. According to Frost & Sullivan, TAVI product sales are currently valued at $8 billion and are growing at double-digit rates. Caranx’s technology aims to help more patients benefit from TAVI by enabling greater procedural accessibility.
“Allowing a broader number of cardiologists and interventional cardiology centers to perform complex procedures, such as TAVI, the Caranx AI-driven software and autonomous robot is at the heart of our mission to save lives and revolutionize medicine,” said Philippe Pouletty, M.D., founder of Caranx and CEO of Truffle Capital.
TAVIPILOT Soft is an AI-powered, intra-operative guidance software that tracks real-time anatomical and instrument landmarks to enable precise valve positioning and delivery. It is compatible with all cardiac imaging systems and is being designed for use with all major TAVI heart valves on the market.
“This successful first trial demonstrates how work that begins as academic research can evolve into real-world impact on everyday medical procedures,” said Pierre Berthet-Rayne, CTO of Caranx. “Our software can now guide clinicians in real time during TAVI procedures, much like a GPS system assists drivers, potentially improving precision and safety. TAVIPILOT Soft has demonstrated impressive robustness to cardiac motion, respiratory motion, and even imaging system movement.”
“At Caranx Medical, our vision extends to developing our proprietary artificial intelligence platform, which currently includes more than 5,000 annotated images across multiple modalities such as CT, fluoroscopy, and echocardiography,” added Jorgen Hansen, CEO of Caranx. “This platform will support the expansion of our AI algorithms to other cardiovascular indications, including mitral and tricuspid valve replacements, helping reshape the landscape of interventional cardiology.”
