-Innovative Transcatheter Valve Repair Device: 12-Month Results of the 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’er Hospital, Hangzhou, China, and presented on his behalf by Committee Chair, Professor Scott Lim from the University of Virginia. The study met its prespecified primary efficacy endpoint with a significant clinical success rate, contributing to the growing evidence supporting the safety and efficacy of transcatheter edge-to-edge repair (TEER) therapy, particularly the DragonFly valve repair system, for treating patients with symptomatic chronic degenerative mitral regurgitation (DMR) 3+ to 4+ with prohibitive surgical risk.
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Novel Transcatheter Valve Repair Device: 12-Month Results of the DRAGONFLY-DMR Trial Revealed at EuroPCR 2023 Novel Transcatheter Valve Repair Device: 12-Month Results of the DRAGONFLY-DMR Trial Revealed at EuroPCR 2023 Novel Transcatheter Valve Repair Device: 12-Month Results of the DRAGONFLY-DMR Trial Revealed at EuroPCR 2023
Background
Severe degenerative mitral regurgitation (DMR) is a prevalent heart valve disease that carries a poor prognosis for patients if left untreated. Although surgical treatment is the gold standard for low-risk surgical DMR patients, a considerable number of patients worldwide still remain untreated due to high surgical risks or other factors. In recent years, TEER has emerged as the preferred technique for treating DMR in patients deemed 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 DMR treatment.
Design
The study was conducted as a prospective, single-arm, multicenter clinical trial to evaluate the safety and efficacy of the DragonFly™ device in treating symptomatic patients with DMR (MR≥3+) with prohibitive surgical risk. The sample size was 120, and the primary endpoint was the clinical success rate, which measured the absence of all-cause mortality, mitral valve reintervention, and >2+ MR at one-year follow-up.
Results
Between May 2021 and January 2022, a total of 120 patients were enrolled at 27 medical centers across China. The mean age of the patients was 74.9±5.7 years, of which 49.2% were female. In all enrolled patients, an independent central echocardiography laboratory rated the baseline MR grade as moderate to severe.
The immediate procedure success rate was 99.2%. The composite success rate, defined as the absence of mortality, mitral valve surgery, or ≥2+ residual MR at 12 months with the DragonFly™ device, was 87.5% (95% confidence interval: 80.1%, 92.3%). The device met the prespecified primary efficacy endpoint.
The patients who achieved MR≤2+ were 90.4% at one month and 92.0% at one year. These results indicate that the MR reduction achieved by DragonFly™ is durable throughout that period.
The mean number of DragonFly devices implanted was 1.5±0.6. The mean procedure duration and device implantation time were 116.7±51.3 minutes and 96.6±47.7 minutes, respectively, considering 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.
Overtime, there was observed reverse left ventricular remodeling (p<0.05), along with significant improvements in functional outcomes and quality of life for patients, as demonstrated by an increase in New York Heart Association class I-II from 32.4% at baseline to 93.6% at 12 months (p<0.001) and the Kansas City Cardiomyopathy Questionnaire from 31.1±18.2 at baseline (44.89±18.37) to 75.40±10.83 at 12 months (p<0.001).
Conclusions
The results of this study demonstrate the high safety and efficacy of the DragonFly™ device for DMR treatment. The device’s design and operational performance have led to sustained MR improvement and reverse left ventricular remodeling, translating into significant improvements in cardiac function and patients’ quality of life.
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 national transfemoral TEER product launched in China. The device is expected to be soon available in other parts of the world, providing a new treatment option for MR patients worldwide.
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SOURCE Hangzhou Valgen Medtech Co., Ltd.
