TAVIPILOT files 510(k): Carvolix targets the US market

Carvolix, formerly Affluent Medical, has submitted a 510(k) application to the FDA for the TAVIPILOT robot. This robot is at the heart of their TAVIPILOT aortic valve implantation platform, essential for their entry into the US market in early 2027. FDA approval is crucial to unlocking a €10 million funding tranche from Claret Capital.

The ROTAO1 study, which demonstrated the success of TAVIPILOT in 10 patients, supports this application. Furthermore, the expansion of TAVI coverage decided by the Centers for Medicare & Medicaid Services should boost demand for this technology.

Carvolix will continue clinical studies with the SAIRO protocol, strengthening its position in the booming TAVI market in the United States.