2023年6月19日

杭州Valgen DRAGONFLY-DMR關鍵試驗結果提出了6月19日,2023中國杭州Valgen醫學技術有限公司,有限公司宣布12個月DRAGONFLY-DMR關鍵試驗的結果評估的安全性和有效性transcatheter-edge-to-edge修複(te)與公司的蜻蜓閥維修係統。獨立設計和開發了蜻蜓Valgen醫學技術,已成功植入在中國300多名患者。該公司指出,蜻蜓施行三通產品將在中國推出。預計設備很快就會出現在世界的其他地方。據該公司介紹,該研究指定其主要功效端點會見一個重要的臨床成功率。研究結果有助於蜻蜓的證據支持三通裝置治療慢性症狀患者3 + 4 +退行性二尖瓣返流(DMR)禁止手術風險。該研究結果發表在英國EuroPCR可能的概率在巴黎舉行的新聞發布會上,法國。DRAGONFLY-DMR試驗由劍安王教授,醫學博士,從哲怎樣醫院,杭州,中國,和代表他提出資格委員會主席斯科特教授Lim,在弗吉尼亞州夏洛茨維爾弗吉尼亞大學的。總結公司的新聞發布會上,作為一個前瞻性研究,隨訪時間,多中心臨床試驗的安全性和有效性評估蜻蜓設備在治療患者症狀DMR(≥3 +先生)在禁止手術風險。主要終點是臨床成功率,測量了自由從全因死亡率,二尖瓣reintervention,先生> 2 + 1年隨訪。 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. Advertisement Subscribe to our weekly newsletter. Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Plus, get our latest issues & supplements delivered to your inbox each month.