Carvolix Reports Positive Outcomes of TAVIPILOT AI Software in Clinical Studies

Carvolix has completed three post-marketing clinical studies of its TAVIPILOT AI software, with 30 patients in France and Australia. The results show 100% procedural success and high clinician satisfaction. This software is designed to assist in Transcatheter Aortic Valve Implantation (TAVI) procedures, enabling precise heart valve positioning.

Following FDA clearance in 2025, TAVIPILOT is being launched in the US. The SAITO clinical program, a series of studies carried out in France and Australia, confirmed the software's effectiveness. Experienced teams reported high levels of satisfaction, with the software showing seamless integration into procedures and reducing workload.

The success of these studies supports Carvolix's commercial strategy and the wider adoption of TAVIPILOT. There were no device-related adverse events, suggesting promising potential for improving TAVI procedural outcomes.