Commercial implant is a first for Abiomed's self-contained device A self-contained artificial heart made by Abiomed Inc., a Danvers cardiac device company, has been successfully implanted in a patient at Robert Wood Johnson University Hospital in New Brunswick, N.J., marking the first commercial implantation of the device.
An earlier version of the device, called AbioCor, was implanted in 14 patients during clinical trials earlier this decade. But the latest procedure, which took place on June 15 and was disclosed by the hospital only yesterday, is the first since the company won Food and Drug Administration approval in 2006 to market AbioCor to heart patients who don’t qualify for transplants.
"It’s a great milestone for the company," Michael R. Minogue, chief executive of Abiomed, said yesterday.
Minogue acknowledged, however, that AbioCor is less likely to be a driver of the company’s revenue in the short term than a symbol of its technological know-how. Technology developed for the plastic-and-titanium replacement heart also has been used in some of Abiomed’s catheter-based heart pumps, which were approved by the FDA over the past year and are projected to serve much larger markets than AbioCor.
"This is a specialty product," Minogue said of the device. "It’s a sign of our technology expertise. No other company makes a completely self-contained implantable artificial heart. But what we’re really focused on is heart recovery and helping people support the heart."
AbioCor is considered self-contained because it has a built-in battery, unlike earlier artificial hearts such as the Jarvik (now called CardioWest), which are tethered to external consoles. It also contains a microprocessor that sends radio signals to a computer monitoring the patient’s health.
The device is not designed to keep a patient alive indefinitely, but to extend the lives of dying patients who are too sick to receive transplants.
In addition to Robert Wood Johnson University Hospital, a teaching hospital affiliated with the University of Medicine and Dentistry of New Jersey, two other hospitals have been approved and trained by Abiomed to implant AbioCor: Johns Hopkins Hospital in Baltimore and St. Vincent Indianapolis Hospital.
The procedure costs $250,000, more than twice as much as a heart transplant, but the price is expected to come down over time.
Dr. Mark B. Anderson, the chief of cardiac surgery at Robert Wood Johnson Hospital who implanted the AbioCor last week, said the patient was a 76-year-old man with congestive heart failure who had previous bypass operations and did not qualify for a transplant.
Hospital officials declined to identify the patient, citing privacy concerns.
"We’re happy to report that the device is working very well and the patient is doing very well, Anderson said yesterday.
Abiomed has made improvements to the software and some of the hardware in AbioCor since the clinical trials. Those tests involved patients whose life expectancy would have been only a few days without the implantation, and at least one of them lived almost two years after receiving the artificial heart. With recent enhancements and a broader class of patients, the prognosis is now much better, Anderson said.
He said the number of implantations will increase and, as the technology improves over the coming decade, artificial hearts may come to rival transplanted human organs.
"Given the demographics of heart failure, there is the potential for a great number of these implantations," Anderson said. "I don’t want to suggest that we start putting the device in everyone, because transplants are a very good outcome."
Minogue said he announced the successful AbioCor implantation at a staff meeting in Danvers yesterday. Employees will celebrate at a summer outing in August. The 27-year-old company has about 340 employees worldwide, more than half of them working at its Danvers headquarters.
Click here for Interactive Diagram of the AbioCor Replacement Heart
Shares of Abiomed edged up 16 cents, or 1.9 percent, to $8.36 yesterday.
Robert Weisman can be reached at weisman@globe.com.
© Copyright 2009 Globe Newspaper Company.
Source: Google Health News
