Carvolix Moves Closer to US Market with TAVIPILOT Robot Submission

Carvolix, formerly known as Affluent Medical, has submitted a 510(k) application to the FDA for its TAVIPILOT Robot, part of an integrated platform to enhance transcatheter aortic valve replacement (TAVI) procedures. This step is crucial for the planned US launch in 2027. Supported by the successful ROTAO1 study, the robot showed effective performance in 10 procedures.

The Integrated TAVIPILOT Platform combines the robot with real-time AI guidance software. The platform aims to meet the need for precise and reproducible TAVI procedures in the evolving US market. Recent updates by the Centers for Medicare & Medicaid Services (CMS) have expanded TAVI accessibility, potentially increasing demand for such technologies.

The TAVIPILOT's precision in valve positioning and catheter control is backed by ongoing clinical studies, aiming to solidify its market entry. With further trials like SAIRO underway, Carvolix continues to build evidence supporting its innovative TAVIPILOT platform.