Carvolix: Positive results at 3 years for the Kalios™ mitral ring

Carvolix, formerly Affluent Medical, announces promising 3-year clinical results for its adjustable mitral valve ring, Kalios™. This pivotal study, Optimise II, demonstrates the efficacy and safety of the device. No device-related adverse events were reported in the 15 patients followed, all of whom had mitral regurgitation ≤2+.

Carvolix's strategy includes seeking FDA approval for commercialization in 2027. The implant allows for percutaneous post-surgical adjustment, avoiding open-heart reoperations for up to 40% of patients. The mitral valve repair market is estimated at $1.5 billion in Europe and the United States.