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Miracor Medical 宣布 PiCSO® 获得 FDA 试验用器械豁免许可

2022-08-23 网络 网络

该研究的主要疗效终点为第 5 天时通过心脏磁共振成像 (CMR) 测量的梗死面积

Miracor Medical SA (Miracor Medical) 宣布获得 FDA 试验用器械豁免 (IDE) 许可,据此公司可以采用其压力控制间歇性冠状窦闭塞 (PiCSO) 技术启动一项关键性研究。PiCSO-AMI-II 多中心、随机试验将纳入 300 例在症状发作后 12 小时内表现为 TIMI 血流 0、1 和 2 级的前壁 ST 段抬高型心肌梗死 (STEMI) 患者。该研究的主要疗效终点为第 5 天时通过心脏磁共振成像 (CMR) 测量的梗死面积。主要安全性终点为第 30 天时器械和程序相关不良事件的疗效目标。将观察并记录主要不良心脏事件和心力衰竭终点,记录期长达 3 年。

PiCSO-AMI-II 将成为第二项评估 PiCSO 改善前壁 STEMI 患者冠脉微血管功能及减少梗死面积作用的主要随机试验。Miracor 目前正在招募 PiCSO-AMI-I 中的 144 例患者,该研究是一项具有里程碑意义的欧洲随机对照试验,其终点与获批的美国试验相当。预计欧洲研究的招募工作将于今年夏天结束。预期未来对这两项研究进行的患者层面汇总荟萃分析将证实心力衰竭住院治疗方面有确切的临床终点改善。

PiCSO 可作为直接经皮冠状动脉介入 (PCI) 术期间心外膜血流恢复后的辅助程序。冠状窦流出间歇性闭塞的独特作用机制是将静脉血流重新分配到梗死周围区域,并通过清除梗死过程中的碎片和其他有害物质来增强冠脉微循环活力。早期非随机欧洲研究表明,该作用可降低冠脉微血管阻塞 (MVO) 的发生率 [3,4] 并减少梗死面积,而这两者与直接 PCI 后的心力衰竭住院治疗改善和死亡率降低密切相关 [5]。尽管患者护理途径有所改善,再灌注策略得到了广泛应用,同时还有辅助药物治疗,但在过去十年内,高危患者在发生 STEMI 后的一年死亡率仍保持在 14% [1]。此外,出院后发生心力衰竭的情况也非常普遍,约 13% 的患者在出院后 30 天确诊,20-30% 的患者在出院后 1 年确诊 [2]。

Gregg W. Stone 教授(美国纽约州纽约市西奈山心脏健康系统学术事务主任)表示,“减少梗死面积和 MVO 是改善心脏病发作患者生存情况和降低心力衰竭风险的关键因素。PiCSO 疗法是一种很有前景的新疗法,可减少梗死面积并改善前壁 STEMI 患者的结局。FDA 批准的随机 IDE 试验旨在验证 PiCSO 的安全性和有效性。”Gregg W. Stone 教授将担任这项研究的主要研究者,瑞士卢加诺 Istituto Cardiocentro Ticino 的 Marco Valgimigli 教授将作为研究的共同主要研究者。

CEO Olivier Delporte 表示,“除联邦医疗保险和联邦医疗补助服务中心 (CMS) 于 2022 年 4 月批准的 ICD-10-PCS 代码外,试验用器械豁免也标志着公司生命周期的一个关键里程碑,展示了公司的积极发展之路。我们期待与我们的临床研究者共同开展一项深入细致的研究,以便美国患者能够受惠于 PiCSO。”公司计划在今年晚些时候筹集资金,以实施这项重要研究,支持公司运营,并评估亚洲的潜在合作伙伴关系。

PiCSO Impulse 系统于 2019 年获得 FDA 颁发的“突破性疗法认定”,并于 2020 年获得 CE 标志。自 2017 年 8 月以来,Miracor PiCSO 技术的开发得到了瓦隆区提供的有偿预支款支持。

注:PiCSO® Impulse 系统仅限在美国用于研究用途。

  1. Szummer, K., et al., Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. European Heart Journal, 2017. 38(41): p. 3056-3065.
  2. Jenča, D., et al., Heart failure after myocardial infarction: incidence and predictors. ESC Heart Failure, 2021. 8(1): p. 222-237
  3. Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. IJC Heart & Vasculature, 2020. 28: p. 100526.
  4. De Maria et al. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention 2018;14(3):e352-e359.
  5. Stone et al. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12, 67(14), 1674-1683.

 

PiCSO® Impulse Console (Photo: Business Wire)

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    2023-01-23 smallant2002
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    2023-06-16 jeanqiuqiu
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    2023-05-28 mgqwxj
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    2022-08-25 海豹
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