-Novel Transcatheter Valve Repair Device: Results of 12-month DRAGONFLY-DMR Trial Presented at EuroPCR 2023

First clinical trial results show promising follow-up

HANGZHOU, China, June 25, 2023 /PRNewswire/ -- On May 17, the 12-month results of the pivotal DRAGONFLY-DMR trial were presented at EuroPCR 2023. This trial was led by Professor Jian'an Wang from Zhe Hospital 'er, Hangzhou, China, and submitted on his behalf by the Chairman of the Admissibility Committee, Professor Scott Lim, of the University of Virginia. The study met its prespecified primary efficacy endpoint with a significant clinical success rate, contributing to increasing the evidence supporting the safety and efficacy of transcatheter edge-to-edge repair (TEER) therapy, and specifically the DragonFly valve repair system, to treat patients with chronic symptomatic degenerative mitral regurgitation (MRD) 3 to 4 with prohibitive surgical risk.

Background

Severe degenerative mitral regurgitation (SMR) is a prevalent heart valve disease that portends a poor prognosis for patients if left untreated. Although surgical treatment is the standard of care for patients with low surgical risk RMD, a considerable number of patients worldwide remain untreated due to high surgical risks or other factors. In recent years, TEER has emerged as the preferred technique for the treatment of MRD in patients considered to be at high surgical risk, supported by a growing body of clinical evidence. Among the innovative TEER devices available, the DragonFly™ Transcatheter Mitral Valve Repair System stands out as a de-novo solution for the treatment of DMR.

Design

The study was conducted as a prospective, single-arm, multicenter clinical trial to evaluate the safety and efficacy of the DragonFly™ device in the treatment of symptomatic patients with RMD (MR≥3) with prohibitive surgical risk. The sample size was 120, and the primary endpoint was clinical success rate, which measured absence of all-cause mortality, mitral valve reoperation, and MR > 2 at 1-year follow-up.

Results

Between May 2021 and January 2022, a total of 120 patients were enrolled in 27 medical centers across China. The mean age of the patients was 74.9 ± 5.7 years, of which 49.2% were women. In all enrolled patients, baseline MR grade was graded moderate to severe by an independent central echocardiographic laboratory.

The immediate success rate of the procedure was 99.2%. The composite success rate, defined as no mortality, mitral valve surgery, or ≥2 MR residual at 12 months with the DragonFly™ device was 87.5% (95% confidence interval: 80.1%, 92.3%). The device met the predetermined primary efficacy endpoint.

The patients who reached MR≤2 were 90.4% at one month and 92.0% at one year. These results indicate that the reduction of MR by DragonFly™ is durable throughout that period.

The mean number of DragonFly devices implanted was 1.5±0.6. Mean procedure duration and device implantation time were 116.7 ± 51.3 minutes and 96.6 ± 47.7 minutes, respectively, taking into account that the TEER technique is new to Chinese physicians. The mean mitral inflow gradient after the procedure and at 12 months was 2.8 ± 1.3 mmHg and 3.2 ± 1.4 mmHg, respectively.

Over time, left ventricular reverse remodeling was observed (p<0.05), along with significant improvements in patients' functional outcomes and quality of life, as demonstrated by the increase in New York City class I-II. York Heart Association from 32.4% at baseline to 93.6% at 12 months (p<0.001) and the Kansas City Cardiomyopathy Questionnaire from baseline 31.1±18.2 (44.89±18, 37) at 12 months (75.40±10.83) (p<0.001).

conclusions

The results of this study demonstrate the high safety and efficacy of the DragonFly™ device for the treatment of DMR. The design and operational performance of the device have resulted in a sustained improvement in MR and left ventricular reverse remodeling, resulting in significant improvements in cardiac function and quality of life for patients.

DragonFly™ was independently designed and developed by Valgen Medtech and has been successfully implanted in over 300 patients in China (DMR/FMR/TR).

DragonFly™ will be the first domestic transfemoral TEER product launched in China. It is anticipated that the device will soon be available in other parts of the world, providing a new treatment option for MR patients worldwide.

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