The long-term data collection for the proof-of-concept study evaluating the HVR Cardio Annuloplasty Ring (MAR) has recently been completed. The prospective single-arm clinical study assessed MAR safety and performance in 11 adults who underwent mitral valve repair surgery. The collected data is currently being analyzed, and preliminary data analyses have yielded promising results.
“The preliminary results of the study have exceeded our expectations”, says Olli Keränen, the CEO of HVR Cardio. According to Keränen, all the main safety- and performance-related objectives of the proof-of-concept study were achieved. HVR Cardio aims to submit the results for publication during autumn 2016.
The MAR study was led by Professor Kalervo 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.