Abiomed Heart Pump Approved
FDA Clears Device
Intended for Use
In Sickest Patients
By DAVID ARMSTRONG
June 3, 2008
The Food and Drug Administration approved a tiny heart pump from Abiomed Inc. that is threaded into the body through an artery to improve blood flow in the sickest of patients.
The pump, which is about the size of a pencil tip, is designed for high-risk patients in need of a stent or who are recovering from a heart attack. The mini pump, called the Impella 2.5, can be inserted quickly to stabilize a patient for surgery and to help the heart during any procedure.
Michael R. Minogue, Abiomed's chief executive, said about 150,000 patients in the U.S. each year are candidates for the pump, which will cost $20,000.
Investors drove shares of the Danvers, Mass., company up $2.32, or 16%, to $17.10 in 4 p.m. Nasdaq stock market trading.
Assaf Guterman, an analyst for Lazard Capital Markets, said the pump had "huge market potential" of perhaps several hundreds of millions of dollars in sales for Abiomed. But in the first year, he sees only $19 million in sales for the pump, partly because the company is rolling out the device to a limited number of hospitals.
To maximize use, Abiomed will have to convince cardiologists and heart surgeons that the new device is at least as good as a decades-old device called an intra-aortic balloon pump. The company has initiated two clinical trials comparing its mini-pump to the balloon pump.
"They need compelling data to create a mind-set that doctors must use the Impella 2.5," said Amy Stevens, a doctor who is an analyst for the Susquehanna Financial Group. "There does have to be a paradigm shift. It is unclear how willing or unwilling cardiologists will be to adopt new technology."
Dr. Stevens said the pump may allow some patients whose hearts were considered so weak that they became transplant candidates to instead undergo surgery that will allow them to recover and avoid a transplant.
Mr. Minogue said the device will help save lives by allowing the sickest patients to survive surgery.
Abiomed is best known for its efforts to develop the world's first self-contained artificial heart. The FDA approved the device in 2006. Mr. Minogue said the company is working with three hospitals that will implant the artificial hearts and is screening patients for the procedure.
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