China-based medical equipment company Valgen Medtech presented the 12-month results of the DRAGONFLY-DMR trial during the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2023.
DragonFly is a transcatheter-edge-to-edge repair (TEER) therapy that has been successfully implanted in more than 300 patients in China.
The trial contributes to increasing evidence supporting the safety and efficacy of TEER therapy, and specifically the DragonFly mitral valve repair system, for treating patients with chronic symptomatic 3+ to 4+ degenerative mitral regurgitation (DMR) at prohibitive surgical risk.
Led by Professor Jian'an Wang from Zhe'er Hospital, Hangzhou, China, and presented on his behalf by the Eligibility Committee Chair, Professor Scott Lim of the University of Virginia, the trial met its pre-specified primary efficacy endpoint with a significant clinical success rate.
Severe DMR is a prevalent heart valve disease with a poor prognosis for patients if left untreated. While surgical treatment is the gold standard for patients with low surgical risk, many patients worldwide continue to be undertreated due to high surgical risks or other factors.
In recent years, TEER has been the preferred technique for treating patients deemed high-risk for surgery, supported by a growing body of clinical evidence, with the DragonFly device being touted as a de-novo solution for DMR treatment. The device has unique features, so it can be controlled, repeatable, and easy to teach newer operators how to implant it.
The prospective, single-arm, study included 120 patients across 27 medical centres in China. The average age of the patients was 74.9 years. There was roughly a 50:50 split of men and women with moderate-severe to severe mitral regurgitation. The immediate procedure success rate was 99.2%, with a composite success rate of 87.5%.
The research revealed the high safety and efficacy of the DragonFly device for the treatment of DMR. It has provided improvement in mitral regurgitation and left ventricular reverse remodelling, which has enhanced patients' cardiac function and quality of life.
According to a report by GlobalData, the transcatheter mitral valve implantation market size was valued at $8.2m in 2022. This was driven by factors such as the increase in the global ageing population and the surge in the prevalence of mitral regurgitation in developed countries.
