8月7日消息--环球医学据悉，近日，美国健康监管机构有条件地批准了心脏设备的组件，该设备有助于降低心脏卒中的风险。

阳光公司的股价上涨了12％，在盘前交易为9.65美元。

该公司表示，批准允许在美国C脉冲心脏辅助装置的后期试验中使用阳光心的升级组件。

该设备，旨在提供一种能够替代心脏泵功能的创伤小、更安全的设备，已经引起了投资者的关注，竞投公司的股价在最后一个月上涨近200％。

该公司表示，升级的组件更轻、更安静、且大小约为之前的一半，而且还采用了一些增强软件。

阳光公司计划对目前正使用C脉冲系统的所有患者使用具有升级组件的设备，其由一个独立的委员会批准。

该公司还表示，本试验及将来的试验新招募的患者将使用升级的设备进行治疗。

该设备主要针对中度心力衰竭患者，包含一个环绕在大动脉外部的囊与端口相连以避免设备直接接触血液。

这个泵可以通过一个导管使空气出入端口，该导管则穿过在皮肤上的小孔并由可充电电池或电源插座供电。

当心脏不能泵足够的血液进入人体时导致心力衰竭。目前近600万美国人正在忍受这种疾病。（环球医学）

原文

Sunshine Heart receives conditional approval for heart device component

(Reuters) - Sunshine Heart Inc said it received conditional approval from U.S. health regulators for a component of its device that helps reduce the risk of heart strokes.
Shares of the Sunshine Heart rose 12 percent to $9.65 in premarket trade.
The approval will allow Sunshine Heart use the upgraded component in a late-stage trial of the C Pulse Heart Assist device in the United States, the company said.
The device, which aims to offer a less invasive and safer alternative to current heart pumps, has caught the attention of investors, who have bid the company's shares up nearly 200 percent in the last one month.
The company said the upgraded part is lighter, quieter and about half the size of its predecessor and also features a number of software enhancements.

Sunshine plans to use the device with the upgraded component on all patients currently on the C Pulse system upon approval from an independent committee.
The company also said that new patients enrolled in the trial and future trials will receive the upgraded device.

The device targets mid-stage heart failure patients and consists of a cuff -- linked to an external balloon -- that wraps around the aorta without coming into contact with blood.

The device targets mid-stage heart failure patients and consists of a cuff -- linked to an external balloon -- that wraps around the aorta without coming into contact with blood.

The pump moves air in and out of a cuff by a tube that passes through a small hole in the skin and is powered by a small rechargeable battery or an electrical outlet.

Heart failure is caused when the heart literally fails to pump enough blood into the body. Nearly 6 million people in the United States are currently living with the condition.

相关链接：http://www.reuters.com/article/2012/08/06/us-sunshine-fda-heartdevice-idUSBRE8750KZ20120806

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