Hangzhou Valgen’s DRAGONFLY-DMR Pivotal Trial Results Presented

June 19, 2023—China-based Hangzhou Valgen Medtech Co., Ltd. announced the 12-month results of the DRAGONFLY-DMR pivotal trial evaluating the safety and efficacy of transcatheter-edge-to-edge repair (TEER) with the company’s DragonFly valve repair system.

The DragonFly was independently designed and developed by Valgen Medtech and has been successfully implanted in more than 300 patients in China. The company noted that DragonFly transfemoral TEER product will be launched in China. It is anticipated that the device will soon become available in other parts of the world.

According to the company, the study met its prespecified primary efficacy endpoint with a significant clinical success rate. The findings contribute to the evidence supporting TEER with the DragonFly device for treating patients with chronic symptomatic 3+ to 4+ degenerative mitral regurgitation (DMR) at prohibitive surgical risk.

The findings were presented at the EuroPCR conference held May 16-19 in Paris, France. The DRAGONFLY-DMR trial was led by Professor Jian’an Wang, MD, from Zhe’er Hospital, Hangzhou, China, and presented on his behalf by the Eligibility Committee Chair, Professor Scott Lim, DO, of the University of Virginia in Charlottesville, Virginia.

As summarized in the company’s press release, the study was conducted as a prospective, single-arm, multicenter clinical trial to evaluate the safety and effectiveness of the DragonFly device in treating patients with symptomatic DMR (MR ≥ 3+) who were at prohibitive surgical risk. The primary endpoint was the clinical success rate, which measured the freedom from all-cause mortality, mitral valve reintervention, and MR > 2+ at 1 year follow-up.

The study investigators enrolled 120 patients at 27 medical centers across China between May 2021 and January 2022. The patients’ mean age was 74.9 ± 5.7 years, and 49.2% were female. In all patients at enrollment, the baseline degree of MR was adjudicated as moderate-severe to severe by an independent echocardiographic core laboratory.

The mean number of DragonFly devices implanted was 1.5 ± 0.6. The mean time for the procedure and the device implantation time was 116.7 ± 51.3 minutes and 96.6 ± 47.7 minutes, respectively, which takes into account that the TEER technique is new to the physicians in China.

The company reported that the immediate procedure success rate was 99.2%. The composite success rate—defined as freedom from mortality, mitral valve surgery, or ≥ 2+ residual MR at 12 months with the DragonFly device—was 87.5% (95% CI, 80.1%-92.3%). The device achieved the predetermined primary efficacy endpoint.

Additionally, 90.4% of patients achieved MR ≤ 2+ at 1 month; at 1 year, it was 92.0% of patients, indicating that the MR reduction by DragonFly is durable over that time frame.

The mean mitral inflow gradient was 2.8 ± 1.3 mm Hg at post procedure and 3.2 ± 1.4 mm Hg at 12 months.

Over time, left ventricular reverse remodeling was observed (P < .05). Also, there was significant improvement in the patients’ functional and quality-of-life outcomes as shown by increased New York Heart Association class I–II from 32.4% at baseline to 93.6% at 12 months (P < .001) and improvement of 31.1 ± 18.2 in Kansas City Cardiomyopathy Questionnaire from 44.89 ± 18.37 at baseline to 75.40 ± 10.83 at 12 months (P < .001).

The investigators concluded that the results of this study demonstrate the high safety and efficacy of the DragonFly device for the treatment of DMR. They advised that the device’s design and operational performance have led to sustained improvement in MR and left ventricular reverse remodeling, resulting in significant enhancements in the patients’ cardiac function and quality of life, noted Hangzhou Valgen Medtech.