插子的保護

2023年5月12日

Emboline IDE的研究開始全身插子的保護導管TAVR 5月9日,2023 - Emboline inc .)宣布了第一個病人被治療的“勢均力敵的保護研究”(ProtectH2H) Emboliner全身導管插子的保護。ProtectH2H臨床試驗的第一個病人是在紐約長老會醫院和哥倫比亞大學醫學中心在紐約,紐約。研究coprincipal調查員塔納齊夫醫學博士,哥倫比亞大學臨床心髒病學研究主任歐文醫療中心治療的病人。Emboliner設備設計提供完整的大腦和身體保護缺血性事件造成的插子的碎片在經導管主動脈瓣置換術(TAVR)程序。該公司接受臨床實驗的設備免稅(IDE)批準這項研究來自美國食品和藥物管理局在2022年12月。Emboliner不是商業化,隻用於臨床實驗的使用,指出該公司。據該公司介紹,ProtectH2H試驗是一個前瞻性,隨機、非盲、多中心、雙臂研究證明的安全性和有效性Emboliner裝置與控製裝置(前哨腦保護係統;波士頓科學公司)患者接受TAVR。這項研究將招收500名病人在20世界中心。研究終點包括30天主要不良心血管和腦血管事件,30天VARC-2中風,和急性栓塞碎片了。 “The Emboliner represents a major advance in embolic protection for cardiovascular procedures by providing full brain and body protection, leaving no major artery to the brain, kidneys, or lower body unprotected,” commented Dr. Nazif in the company’s press release. “The device has shown promising results in the smaller SafePass feasibility studies, and we look forward to the results of this pivotal randomized trial as we seek to bring this exciting new technology to our patients.” Alexandra J. Lansky, MD, principal investigator for the trial, added, “The mounting body of evidence on embolic protection devices suggests that embolic protection is no longer considered controversial or optional, it’s just the right thing to do to protect your patients from the very real risk of stroke. The Emboliner represents a new generation in embolic protection devices by fulfilling an unmet need in providing full brain and body protection from stroke and other ischemic events caused by debris released during TAVR. We look forward to the study results.” Dr. Lansky is Professor of Medicine (Cardiology), Director of the Clinical Research Program at Yale University School of Medicine in New Haven, Connecticut. 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.