The statistical analysis of HVR Cardio’s proof-of-concept study evaluating the HVR Cardio Annuloplasty Ring (MAR) has recently been completed.
As previously expected based on preliminary data analyses, the main safety- and performance- related objectives of the study were successfully achieved. The newly analyzed results indicate that the MAR ring is well tolerated and induces improvement of heart condition in patients with mitral regurgitation. In the study, patients with mitral regurgitation underwent a surgery, in which their mitral valve was repaired with the MAR ring.
According to the cardiologist Dr. Tapio Aalto who conducted the central echo readings of the study, repair based on the MAR ring led to improved heart condition in all patients who were analyzed during the study. The coordinating investigator of the study, professor Kalervo Werkkala, states that although the 2-year follow-up time has ended, the study patients are still in good condition. Therefore also the long-term tolerability of the MAR ring seems promising so far. The study results strongly support the development of HVR Cardio’s second mitral repair product, the catheter-based CathHELIX, which is currently under preclinical investigation.
The MAR study was led by Professor Werkkala and the principal investigator of the study was Dr. Antti Vento, PhD. The study was carried out in the Lung and Heart Center of Helsinki University Hospital Finland, and the treatment time consists of over 600 patient care months gathered from 11 patients with a successful MAR implantation.