UPDATE 2-Abiomed raises revenue outlook, wins US approval for heart pump

Tue Jan 27, 2015 7:26pm EST
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(Adds details, analyst comment; updates shares)

Jan 27 (Reuters) - Medical device maker Abiomed Inc raised its full-year revenue forecast and said the U.S. Food and Drug Administration had approved its heart pump, sending its stock up about 30 percent in extended trading.

Abiomed's heart pump, Impella RP, helps blood circulation for up to 14 days in patients who develop acute right heart failure following implantation, myocardial infarction, heart transplant or open-heart surgery.

The device is the first percutaneous, single access pump approved for right heart support, the company said.

In surgery, 'percutaneous' pertains to any procedure that allows access to internal organs via a needle-puncture of the skin, rather than by using an "open" approach where organs must be exposed, typically using a scalpel.

The approval comes in the form of a humanitarian device exemption (HDE), given for devices to treat rare conditions, affecting less than 4,000 people in the United States per year, and ones which have no comparable products.

The decision comes about 6 weeks earlier than expected, and the device will likely address upwards of 8,000 patients, Leerink Swann analysts wrote in a note.

The FDA, on Tuesday, asked the company to conduct two post-approval studies to evaluate Impella RP's safety and benefit profile.

Higher sales of other Impella devices helped Abiomed post better-than-expected revenue for the third-quarter ending Dec. 31.   Continued...