Flow Triever——唯一FDA批准肺栓塞去除器械

原标题:Flow Triever——唯一FDA批准肺栓塞去除器械

Flow Triever——唯一FDA批准肺栓塞去除器械

肺栓塞(pulmonary embolism,PE),是由于内源性或外源性的栓子堵塞肺动脉主干或分支,引起肺循环障碍的临床和病理生理综合征。包括肺血栓栓塞症、脂肪栓塞综合征、羊水栓塞、空气栓塞、肿瘤栓塞等。其中肺血栓栓塞症(PTE)是最常见的PE类型,指来自静脉系统或右心的血栓阻塞肺动脉或其分支所致的疾病,以肺循环和呼吸功能障碍为主要临床表现和病理生理特征,占PE的绝大多数,通常所称的PE即指PTE。

近日,FDA首次批准了Flow Triever用于治疗肺栓塞,也是唯一一款用于肺栓塞去除器械。一开始Flow Triever是一款基于导管的血栓去除医疗器械,旨在消除外围血管的凝块。Inari Medical通过不断研究优化,使Flow Triever预期用途进一步扩展。

Flow Triever——唯一FDA批准肺栓塞去除器械

Flow Triever

Flow Triever由FlowTriever Catheter(FTC)、Aspiration Guide Catheter(AGC)和Retraction Aspirator(RA)三部分组成。

Flow Triever——唯一FDA批准肺栓塞去除器械

Flow Triever——唯一FDA批准肺栓塞去除器械

Flow Triever工作方式

Flow Triever——唯一FDA批准肺栓塞去除器械

Flow Triever临床效果

Inari Medical对Flow Triever进行一项前瞻性、多中心的临床研究,来自于美国18个地方的106位急性肺栓塞(PE)患者参与临床研究。所有的患者都是右心室/左心室(RV/LV)比值大于0.9。Flow Triever通过机械方式去除肺动脉中的血栓。

术后48小时后,患者的右心室/左心室(RV/LV)比值从1.53降至1.15(P<0.0001)。这项研究还显示了30天的优异安全性,主要不良事件发生率低于3.8%,没有发现与器械相关的并发症。平均ICU住院时间为一天,总住院时间平均天数为三天。

研究者对Flow Triever临床效果评价:

“The significant improvement in right heart function shown with the FlowTriever System compares very favorably with outcomes of other techniques used to treat PE,” said Dr. Thomas Tu. “At the same time, the impressive safety profile reflects the advantages of FlowTriever’s purely mechanical approach which avoids the use of thrombolytic drugs and resulting risk of bleeding complications”.

“The results of the FLARE study mark an exciting advancement in the treatment of acute pulmonary embolism patients,” stated Victor Tapson, MD, Associate Director, Pulmonary and Critical Care Division, Cedars-Sinai Medical Center, Los Angeles and Co-Principal Investigator of the study. “Until now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications.”

The FlowTriever System represents a breakthrough in treatment options for this large patient population,” added Dr. Ken Rosenfield, MD, Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and Co-Principal Investigator of the study. “These results indicate that mechanical thrombectomy with the FlowTriever System will play an increasing role in the management of pulmonary embolism.”

Flow Triever——唯一FDA批准肺栓塞去除器械

Inari Medical

Inari Medical, Inc.是一家私人控股医疗器械公司,致力于开发创新的基于导管的技术来治疗静脉血栓栓塞症(VTE)。Inari Medical的重点是在不使用溶栓药物的情况下,能够安全地从大血管中安全地清除大量凝块。Inari Medical已经开发出两种新型的机械血栓取出技术平台,FlowTriever和CytRiver。两款产品均通过的FDA批准,同时也已获得CE批准。Inari Medical, Inc.成立于2013,是 Inceptus Medical(一家医疗器械孵化器)的一个分支。该公司由GaldHealthHealthor、VestANTVANCE、美国风险合作伙伴、创始人和其他私人投资者支持。

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