Caranx Medical’s TAVIpilot Soft Used in First Clinical Cases

November 21, 2025—Caranx Medical, which is headquartered in France, announced the first clinical use of the TAVIpilot Soft autonomous robot for transcatheter aortic valve replacement (TAVR).

The company stated that the TAVIpilot Soft is an artificial intelligence (AI) software for real-time intraoperative guidance of TAVR. It is compatible with all cardiac imaging systems and will be compatible with all main TAVR heart valves on the market.

The first procedure was performed on October 20 and 22, 2025, by Didier Tchétché, MD, at Clinique Pasteur in Toulouse, France, as part of the SAITO-1A first-in-human (FIH) trial. The study included 10 patients with severe aortic stenosis who were treated via the transfemoral approach during a TAVR procedure using a Sapien 3 valve (Edwards Lifesciences).

According to Caranx, results from the trial confirm the feasibility, safety, and technical robustness of TAVIpilot Soft during TAVR procedures. There were no technical issues in 100% of the procedures, enabling autonomous identification of anatomic landmarks and accurate assessment of implantation depth during the TAVR procedure.

Comparative measurements between the TAVIpilot Soft-predicted valve positioning and the final implanted position selected by the investigator demonstrated the accuracy of the software in all cases. Additionally, there were no intraprocedural complications, and investigator satisfaction was high, reported the company.

In July 2025, Caranx announced FDA clearance for TAVIpilot Soft. The company advised that the United States market introduction of TAVIpilot Soft is expected by the end of 2025.