Mon Aug 6, 2012 8:37am EDT
(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 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.
(Reporting by Adithya Venkatesan in Bangalore; Editing by Saumyadeb Chakrabarty)
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Sunshine Heart receives conditional approval for heart device component