The Impella ECP. [Image courtesy of Abiomed/Johnson & Johnson MedTech]Johnson & Johnson MedTech reported positive data for the Abiomed Impella ECP transvalvular axial flow pump with compressible pump architecture.

Impella ECP。[图片由Abiomed/Johnson＆Johnson MedTech提供]Johnson＆Johnson MedTech报告了具有可压缩泵结构的Abiomed Impella ECP跨瓣轴流泵的积极数据。

Investigators presented results at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Dr. Amir Kaki led the FDA IDE study — the first completed pivotal trial for Impella ECP — as principal investigator.

研究人员在华盛顿特区的经导管心血管治疗（TCT）2024年会议上公布了研究结果。阿米尔·卡基博士作为主要研究者领导了FDA IDE研究，这是Impella ECP首次完成的关键试验。

J&J said the study, which met its primary endpoint, enrolled 256 patients at 18 sites in the U.S. Its MACCE (Major Adverse Cardiac and Cerebrovascular Events) rate at 30 days came in at 6.3%. That landed significantly below the pre-defined performance goal, according to a news release.

强生说，这项符合主要终点的研究在美国18个地点招募了256名患者。其30天的MACCE（主要不良心脑血管事件）发生率为6.3%。据一份新闻稿称，这大大低于预定的绩效目标。

The company said Impella ECP demonstrated safety and efficacy for use in high-risk percutaneous coronary interventions (PCI). Operators chose the 8Fr Angio-Seal as the first closure method in 70% of patients, registering a 92% success rate.

该公司表示，Impella ECP在高危经皮冠状动脉介入治疗（PCI）中显示出安全性和有效性。操作者选择8Fr Angio Seal作为70%患者的第一种闭合方法，成功率为92%。

Impella ECP features a 9 Fr size at insertion for implantation and removal using small bore access and closure techniques. After insertion, it expands to 21 Fr to provide circulatory support and left ventricular (LV) unloading for high-risk PCI. The device remains investigational, but Johnson & Johnson said it plans to submit Impella ECP to the FDA as a next step..

Impella ECP在插入时具有9 Fr的尺寸，可使用小孔进入和闭合技术进行植入和移除。插入后，它扩展到21 Fr，为高危PCI提供循环支持和左心室（LV）卸载。该设备仍处于研究阶段，但强生公司表示，下一步计划将Impella ECP提交给FDA。。

“The study met its prespecified 30-day primary endpoint with low complication rates and the 9Fr arterial access enabled a high success rate closing with an 8 Fr Angio-Seal,” said Kaki. “Impella ECP technology with small-bore access and closure offers benefits for patients and physicians.”

Kaki说：“这项研究达到了预先设定的30天主要终点，并发症发生率低，而9Fr动脉通路能够以8Fr血管封条实现高成功率。”。“Impella ECP技术具有小口径接入和闭合功能，可为患者和医生带来好处。”