A piece of news went out over the wires yesterday that I think deserves a little more explanation: Danvers, MA-based Abiomed announced that it had received a new FDA approval for its AbioCor artificial heart. The item caught my eye because I’ve been loosely following this technology—a fully implantable mechanical heart replacement—since 1999, when I edited Antonio Regalado’s excellent profile in Technology Review of Abiomed’s attempts to commercialize the device. The device, I remembered, was finally approved in September of 2006—so why a new approval now, I wondered?
It turns out, I learned from Abiomed CFO Daniel Sutherby yesterday evening, that despite getting the go-ahead to start selling the device back in 2006, Abiomed never has done so. Instead, he says, the company made the strategic decision to improve the heart’s software and reliability—and what was announced yesterday was an approval of those upgrades.
It’s a rare move for a company to hold back on marketing after working so many years to get a product approved in the first place. (One other recent example is orthopedic-implant firm ConforMIS, which I profiled in November. ) But for Abiomed, I think the cautious approach is the smart one. Artificial hearts have a complicated history, with early trial volunteers Barney Clark and William Schroeder (whose diseased hearts were replaced with a device quite different form Abiomed’s) suffering terribly from clots, strokes, infections, and other side effects. (Regalado’s story lays out more fully how the field’s history affected Abiomed’s initial work on the AbioCor, then known as the PulsaCor.)
In Abiomed’s own human trials of the original AbioCor, begun in 2001, results were mixed. Over the course of several years, the company implanted the device in 14 men whose hearts had failed and whose doctors deemed them ineligible for a transplant and unlikely to live for more than a month. Two of those patients died during the implantation surgery, and two died when the device failed; all of the volunteers had some degree of bleeding complications. But 10 of the patients survived longer than two months, and four of those people were even able to leave the hospital for some activities. Overall, the volunteers survived an average of four and a half months after the surgery, with one patient surviving 512 days.
With the newly approved upgrades, Abiomed believes it has a device that’s finally ready for commercialization. “Now we’re ready to go,” says Sutherby. The approval allows the company to sell up to 4,000 units a year in the United States to heart-failure patients who are ineligible for transplant and unlikely to survive otherwise. At a price of $250,000 per unit, that’s “literally a billion-dollar monopoly,” he says. (Other heart-support devices exist, but the AbioCor is the only one that replaces the whole heart and is fully implanted, without any wires or tubes sticking through the skin.) And that figure doesn’t include additional charges for diagnostic support, clinical support, training, and ancillary technology, he adds.
Sutherby says sales of the device will likely begin in two to three months, after training is complete at the four surgical centers (in Maryland, New Jersey, Texas, and Indiana) that the company has selected for a controlled roll-out of the technology. Abiomed may add an additional U.S. center, he says, and over time may add up to five centers overseas.
The company is also working on a smaller version of the artificial heart, the AbioCor II, that would last up to five years and fit in more patients. (The AbioCor I is too large for the majority of women and for some men.) Clearly this could open the door to a much wider market, but Abiomed is not yet revealing when it will seek approval for the newer version. Says Sutherby, “We want to see AbioCor I work for the patients and for the company first.”
