Abiomed announces first commercial AbioCor artificial heart implantation

June 24, 2009 by MassDevice staff

A 76-year-old man is the first patient implanted with the Danvers cardiac device maker's artificial heart since it won FDA approval in 2006.

A 76-year-old patient in New Jersey is said to be recovering well after receiving Abiomed Inc.'s AbioCor artificial heart.

It's the first commercial implantation since the Danvers cardiac device maker's artificial heart went through clinical trials and won humanitarian device exemption approval from the Food and Drug Administration in 2006.

The device, which made headlines early this decade as the first self-contined artificial heart, is designed for patient with acute heart failure who don't qualify for a transplant.

The 76-year-old male patient at Robert Wood Johnson University Hospital in New Brunswick, N.J., was diagnosed with congestive, end-stage heart failure. About a week after the surgery he's showing signs of a strong and stable recovery, the company said.

CEO Michael Minogue told MassDevice the $250,000 device, which is designed to run for 18 to 24 months after implantation, is the culmination of more than 30 years of work by scores of researchers.

Citing in particular the dedication of chief science officer Dr. Robert Kung, who was on hand for the procedure in New Jersey, Minogue said Abiomed's interest in the artificial heart is less commercial than humanitarian.

"The intent of the device is to get patients out of the hospital and get them home to enjoy some quality of life," he told us. "There is no other artificial heart and there is no other option. It offers a solution for thousands of patients with no other alternatives ... to get good patient quality-of-life and give more alternativess to cardiologists."

But the state-of-the art device is only a small part of Abiomed's business, Minogue said. Four recent nods from the FDA — 510(k) approvals for the Impella 2.5, 5 and LD models and pre-market approval for the AB Portable driver component of its AB5000 circulatory support system — have the company predicting a 25 percent surge in revenues for fiscal 2010.

"The revenue growth is driven around new product approvals," Minogue said. "Tthe Impella itself is kind of a breakthrough technology that pumps blood for the heart so you can provide a safer angioplasty and help the heart muscle recover."