Carvolix Reports Positive 3-Year Results for Kalios™ Mitral Ring

Carvolix, previously known as Affluent Medical, has announced favorable 3-year clinical results for its adjustable mitral ring, Kalios™. According to the study, all patients treated with the device met the primary endpoint for mitral regurgitation at the 3-year mark.

The pivotal Optimise II study revealed that the Kalios™ ring maintained its effectiveness and safety, with no device-related adverse events reported among the 15 patients evaluated. The study showed that all patients had a mitral regurgitation grade of ≤2+, attesting to the device's durability.

Carvolix plans to pursue FDA approval for potential commercialization in 2027. This innovation highlights the ring's unique ability to be adjusted percutaneously, paving the way for a new standard in mitral valve repair by potentially reducing repeat surgeries for a significant portion of patients.