(Adds dropped words “less than” in paragraph 3, corrects to “higher sales of other Impella devices” from “higher sales of the device” in paragraph 5)
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 nearly 32 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 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 agency, 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.
The company’s revenue rose 34 percent to $62 million, well ahead of analysts’ average estimate of $53.2 million, according to Thomson Reuters I/B/E/S.
Abiomed also raised its revenue forecast for the year ending March 31 to $223-$226 million from $209-$212 million.
Analysts on average expect $211.4 million.
It hiked its operating margin estimate for the year to 9-11 percent from 1-4 percent. (Reporting by Anjali Rao Koppala in Bengaluru; Editing by Ted Kerr and Savio D’Souza)