Thoratec’s Heart-Pumping Device Gets FDA Clearance

　　美国食品药品管理局认证了加利福尼亚Thortec公司Pleasanton设计的一款新型的心脏泵辅助装置用于等待心脏移植的晚期心力衰竭患者。

　　HeartMate II左心辅助系统仅有3英寸长，1英镑重。这一装置可以通过电池供电，也可以通过外接电源供电，供电线通过患者皮肤连接到外置的控制装置。

　　据华尔街日报报道，“HeartMate II是心脏器械技术的重要进步。目前，很多等待心脏移植的患者还使用大尺寸的心脏辅助装置。” Daniel Schultz博士（FDA设备及放射中心主任）说。

　　HeartMate II被设计为置入连接到患者的心脏，当患者接受心脏移植时被拆除。它每分钟最多可以泵出10升血液——正常心脏的输出量——Thoratec在一份印刷品上公布。这一设备在2005年已经在欧洲获得认证。

　　这一认证根据一项26个移植中心的126例患者的研究，该研究现实接受HeartMate II 的患者57％生存到接受心脏移植，这余既往使用的经过认证的心脏辅助装置相当，FDA表示。

　　FAD还要求制造商提供关于设备使用情况的认证后研究结果。

Thoratec’s Heart-Pumping Device Gets FDA Clearance

The U.S. Food and Drug Administration approved a new type of heart-pumping device designed by Pleasanton, Calif.-based Thoratec Corp to help advanced-stage heart failure patients survive while awaiting heart transplants.

The HeartMate II Left Ventricular Assist System is just 3 inches in length and weighs about 1 pound. The device can be powered either by battery or while connected to an electrical outlet, as a cable that powers it, passes through the patient’s skin to an external controller.

“The HeartMate II is an important advance in mechanical heart technology. Until now, some heart transplant candidates have been underserved due to the large size of previously approved heart assist devices,” stated Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, according to the Wall Street Journal.

The HeartMate II is designed to be implanted next to the patient’s heart and then removed after the patient gets a heart transplant. It can pump up to 10 liters of blood per minute – the full output of a healthy heart – Thoratec said in a press release. The device has already been approved in Europe since November 2005.

The approval comes after a clinical study of 126 patients at 26 transplant centers showed that 57 percent of patients with the HeartMate II survived the heart transplant, which is comparable to the survival of patients treated with previously approved heart-assist devices, the FDA said.

The agency also added that the manufacturer will be required to conduct a post-approval study of the device’s performance.

source: www.dxy.cn