机械取栓装置获准用于急性卒中治疗

Stryker神经血管公司8月13日宣布，其生产的用于急性缺血性卒中患者的取栓装置已被美国食品药品管理局(FDA)批准上市。该公司在声明中表示，这种装置将以“Trevo Pro取栓器”的名字上市。

Trevo Pro取栓器处理血栓的示意图。

今年5月份，该公司公布了TREVO 2研究的结果。这项随机临床试验在急性缺血性卒中患者中对Trevo装置和另一种Stryker产品——Merci取栓器进行了比较。纳入标准为年龄18~85岁、临床症状和体征符合急性缺血性卒中、组织纤溶酶原激活物(TPA)治疗失败或有TPA禁忌证。

该产品的上市前通告指出，随机分至Trevo装置治疗组的患者的术后血管重建率为92%，高于Merci取栓器治疗组的77%，差异有显著性。而且Trevo Pro取栓器组患者的住院时间更短、国立卫生研究院卒中量表评分有所改善。

这种装置由Concentric医学公司研发，Stryker于2011年10月份收购了这家公司。

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Mechanical Embolectomy Device Cleared for Acute Stroke Treatment

By: ELIZABETH MECHCATIE, Cardiology News Digital Network

A thrombus retrieval device for use in patients experiencing an acute ischemic stroke has been cleared for marketing in the United States by the Food and Drug Administration, the manufacturer announced on Aug. 13.

The device will be marketed as the "Trevo Pro Retriever," according to the statement issued by Stryker Neurovascular.

In May, the company announced the results of the TREVO 2 study, a randomized, clinical trial that compared the Trevo device with another Stryker device, the Merci Retriever, in patients experiencing an acute ischemic stroke. The inclusion criteria were patients aged 18-85 years presenting with clinical signs and symptoms consistent with an acute ischemic stroke, who had either failed; tissue plasminogen activator (TPA) therapy or in whom TPA was contraindicated, according to the description of the study.

The postprocedure revascularization rate was 92% among patients randomized to treatment with the Trevo device, compared with 77% among those treated with the Merci Retriever device, a significant difference, according to the statement announcing the device’s premarket notification clearance. Performance measures that included shorter hospital stays and improvement in the National Institutes of Health Stroke Scale also favored the Trevo Pro Retriever device, the statement said.

The device was developed by Concentric Medical, which was acquired by Stryker in October 2011.

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