Abiomed Wins FDA Approval of Heart Pump

Xconomy Boston — 

Abiomed got a healthy boost this morning. The FDA cleared the company’s new heart pump for sale in the U.S., enabling it to potentially reach a market of about 14,000 interventional cardiologists. Shares of the Danvers, MA-based company (NASDAQ: ABMD) shot up 13 percent to $16.75 at 12:14 p.m. Eastern Standard time.

The Impella 2.5 Cardiac Assist Device, which is already approved in some 40 other companies, is designed to help very sick patients’ hearts keep blood circulating for short periods of time. The pump can move as much as 2.5 liters of blood a minute, and it cleared for use for up to six hours, the company said. Like standard heart-helping pumps it’s threaded into the heart through an artery in the leg, but the Impella is different because it can deliver more blood volume, and it unloads blood from the left ventricle, relieving stress on the heart.

The Impella costs $20,000 per disposable unit, and is reimbursed by Medicare, said Michael Minogue, the company’s chief executive officer, on a conference call this morning with analysts. He didn’t offer a specific sales forecast.

“This marks a great day for the company and for heart failure patients in the U.S.,” Minogue said.

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