FDA限制使用Wingspan支架

美国食品药品管理局(FDA)于8月8日发布声明和安全性通讯，宣布批准了对Stryker Wingspan支架系统标签的修改，对该支架系统适用患者的范围作出了限制。

新标签明确指出了最可能从这一支架系统治疗中获益的患者。自2005年该系统获得批准以来的多项研究数据提示，部分患者接受该系统治疗的风险——包括卒中和死亡——可能超过获益。

FDA器械与放射健康中心主任Jeffrey Shuren博士在声明中指出：“在慎重考虑现有的安全性信息之后，FDA认为这种器械仍然可以用于其他治疗均已不适用的部分患者。”

根据新标签，Wingspan系统仅获准用于年龄22~80岁、符合4项标准的患者。这4项标准是：尽管接受了积极药物治疗，仍发生≥2次卒中；最近1次卒中距计划使用Wingspan系统治疗的时间超过7天；狭窄程度介于70%~99%(由于与复发性卒中相关的颅内动脉粥样硬化)；前一次卒中后恢复良好，部分定义为采用Wingspan系统治疗前的改良Rankin评分≤3分。

根据安全性通讯，Wingspan系统不能被用于“治疗在7天内出现症状的卒中患者，或治疗短暂性缺血发作(TIA)”。

FDA是在审查原始临床研究、上市后研究和SAMMPRIS(对颅内动脉狭窄患者采取支架置入与积极药物治疗用于预防复发性卒中的比较)研究的数据后批准上述修改的。

安全性通讯指出，“只有当主管医生所在医院的审查委员会已批准使用时，才可能使用Wingspan对患者进行治疗”，而且主管医生在对患者使用Wingspan系统进行治疗之前有责任获得审查委员会的批准。

临床医生可以将与Wingspan系统有关的不良事件报告至FDA的MedWatch系统。点击查看这份安全性通讯。

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By: HEIDI SPLETE, Cardiology News Digital Network

New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.

The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.

"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.

According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."

The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.

The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.

Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.

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