A medical equipment company based in China has presented evidence to support an innovative solution for degenerative mitral regurgitation (DMR) patients who are at high risk for surgery.
The 12-month findings from the DRAGONFLY-DMR trial was presented at the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2023 conference.
The DragonFly procedure, a transcatheter-edge-to-edge repair (TEER) therapy, has been successfully implanted in 300-plus patients in China.
The trial, conducted by medical equipment company Valgen Medtech, adds to the growing body of evidence supporting the safety and effectiveness of TEER therapy – specifically focusing on the DragonFly mitral valve repair system – and treating patients with chronic symptoms.
Led by Professor Jian'an Wang from Hangzhou's Zhe'er Hospital, China, the trial results were presented by Professor Scott Lim of the University of Virginia on behalf of the Eligibility Committee Chair.
It successfully achieved its pre-defined primary efficacy endpoint, demonstrating a significant clinical success rate.
While surgical treatment is considered the gold standard, many individuals worldwide are not adequately treated due to the high risks associated with surgery or other factors.
When left untreated, DMR impacts quality of life, leads to heart failure, and is associated with an increased mortality.
In recent years, TEER has become the preferred technique for treating these patients.
The unique features of the DragonFly device enable precise control, repeatability and ease of implantation, making it suitable for training new operators.
The prospective, single-arm study involved 120 patients across 27 medical centres in China, with an average patient age of 74.9 years.
Approximately an equal number of men and women with moderate-severe to severe mitral regurgitation were included. The immediate procedural success rate was 99.2%, with an overall composite success rate of 87.5%.
The device has led to improvements in mitral regurgitation and left ventricular reverse remodelling, thereby enhancing patients' cardiac function and overall quality of life.
The DragonFly transfemoral TEER product will initially be launched in China, but it is anticipated it will become accessible globally.
According to a report by GlobalData, the market size for transcatheter mitral valve implantation reached $8.2 million in 2022.
This growth was driven by factors such as the increasing global ageing population and the rising prevalence of mitral regurgitation in developed countries.
