Abiomed gained worldwide attention last year by implanting six of its self-contained, AbioCor hearts into critically ill patients. But surgeons have tried the procedure just once this year, and not at all since ending a moratorium on recruiting three months ago.
Abiomed has said the device could someday break into an enormous market and help the 100,000 Americans who need heart transplants each year. Only about 2,000 get them.
The company says the trial has met its limited goals: helping patients live 60 days, double the expectation, with an improved quality of life. Of seven people implanted with the device so far, one is still alive. That patient has survived more than a year. Other patients lasted as long as 142, 151 and 292 days.
The company faces a lawsuit by the widow of one patient who died. Abiomed officials say the lawsuit hasn't affected their decisions.
The company says the device was not to blame for the deaths of any of the patients, all of whom were critically ill with a variety of health problems when they received the AbioCor.
But it faces competing incentives. Like any manufacturer, it is eager to complete tests so it can start selling the product. On the other hand, it has no interest in seeing the product's average survival rate decline.
The slowdown of the trial has dispirited investors. Abiomed shares, which traded at $17 last December, fell below $4 on Tuesday on the Nasdaq Stock Market.
Executives tried to offer reassurance on a conference call Tuesday, saying the company continues to push to complete the first round of 15 implants. They said Abiomed simply hasn't found enough patients who meet its stringent criteria, which include a life expectancy of 30 or fewer days without the device.
"I think the trick is they want to make sure the patients are healthy enough to live a long life under the implant, and yet the patient has to be in pretty dire straights to be considered," said Banc of America Securities senior analyst Kurt Kruger.
But some say Abiomed has raised its eligibility standards and is playing it too safe.
"I think they're being overly ethical," said Bill Frain, a large investor in the company. "They're being so cautious that they're hurting themselves."
The firm's leaders also are declining — at least for now — to make one change that could broaden the pool of candidates: allowing family members to give proxy approval for the procedure. Currently, patients must give their own consent, which limits the pool to patients who are responsive.
"It's troubling, frankly, very troubling," Kruger said. "We're frustrated. In our view, this should prompt a reassessment of the entrance criteria. (They've) made the entrance requirements so strict, they'll never see any patients."
Frain said he's been told Abiomed has even raised its standards for candidate health, and that none of the patients who received the device last year would qualify today.
"They don't want to take a chance of them dying immediately," said Frain. "We've been told that at any given moment they've been monitoring from three to seven patients. But those patients die before they go ahead and implant the AbioCor."
Abiomed spokeswoman Sara Goldstein denied that standards have changed, saying it's up to doctors to screen patients.
According to Abiomed, candidates must suffer from bi-ventricular heart failure, be older than 18, unresponsive to existing therapies and ineligible for a natural heart transplant.
"These aren't things that are flexible," she said. "These are very concrete criteria."
Goldstein said the company continues to monitor candidates and is eager for the next implant to take place. She said it could happen at any time.
In its most recent filing with the SEC, AbioMed warns investors that its timetable for seeking FDA approval in 2004 must be flexible.
"This plan, subject to regulatory approval, is dependent upon our ability to enroll additional patients in the initial clinical trial over the next twelve months, and to demonstrate acceptable clinical performance including extension of life with acceptable quality and level of adverse events," the filing read.