Medical Device Daily

While the FDA's approval this week for commercialization of the AbioCor artificial implantable heart is a clear breakthrough for heart failure patients, the realistic difficulties of putting the technology into clinical practice will be more like waiting-to-exhale than breathtaking.

The approval marked “a great day” for Abiomed (Danvers, Massachusetts), manufacture of the AbioCor, said Mike Minogue, company president/CEO. But he acknowledged a large amount of work yet to be done before the first few patients are implanted with the device.

“There are a couple of phases we have to go through first,” Minogue told Medical Device Daily, in describing what will be a carefully controlled roll-out to the market and patient use.

The most important step in this roll-out, he said, is “to go back and train and retrain the centers signed up” to do the implantation. This is necessitated by the fact that there have been no implants of the AbioCor for more than two years, the last implant coming in May of 2004.

Besides validating and retraining the centers that did the implantations from 2001 to 2004, Abiomed will be asking them to help train new centers. This will include using “all the videos from the surgeries” to demonstrate the “challenges” of the procedure.

Minogue said this process would take from six to eight months, beginning with three to five centers and then expanding in phases to what he set as 10 centers as “a maximum.”

And he declined to project the numbers of patients who might receive the AbioCor, either short-term or long-term.

In contrast to other new-technology introductions, the effort won't require a large marketing campaign – or any marketing at all. He said patients will be referred to the implanting hospital through physicians and the network of about 100 heart transplant centers, targeting those patients who are designated as unable to benefit from the standard heart transplant or unable to withstand the transplant procedure.

Minogue acknowledged that a key to the success of the AbioCor has been – and will always be – the careful selection of patients, individuals who have very sick hearts and only a short time to live but with other organ systems working well or capable of being revived via the AbioCor.

With discharge to home being a key goal, “If their organs have completely failed, it's likely that they're not going to be able to leave the hospital,” Minogue said.

This greatly narrows the pool of patients for the first generation of the AbioCor, and seen early on as a major difficulty in the company's 15-patient trial.

An even more stringent standard for implantation, Minogue said, is the ability of the patient to withstand anticoagulation therapy, a key finding from the trial when patients died as a result of not being able to deal with anticoagulation drugs, rather than from a device failure.

As the Abiomed team gears up to take on these clinical challenges, another team developed by the company must take on what is perhaps an even larger difficulty: the bureaucratic windmill of reimbursement known as the Center for Medicare and Medicaid Services.

Abiomed has done the initial foundation work here and achieving the milestone of FDA approval now allows CMS to make a decision – putting to the forefront a key question: Why provide reimbursement for what is essentially the healthcare endgame of putting someone on what is essentially a life support system?

Here, Abiomed is playing off the cost of AbioCor therapy against what it computes as even more expensive end-stage care, quite frequently protracted over weeks and months through a combination of high-priced drugs, high-priced physician and nursing care and high-priced facility costs, such as care in an ICU. Minogue put such care at many hundreds of thousands of dollars, or even millions more, than AbioCor therapy.

The clinical goal for the AbioCor is to provide from 18 to 24 months of additional life, but more importantly, additional life with greater quality than available to end-stage heart failure patients.

The poster patient for the AbioCor is one of the clinical trial subjects who spent 11 months at home supported by the device and “able to enjoy anniversaries, sporting events, car races and food he was unable to eat in the previous four years,” Minogue said. He added: “Some of the patients who didn't leave the hospital felt better than they had in months or years as a result of more blood flow, perfusion to the organs.”

While patients implanted with the device will need some training and oversight of the heart's operation at home, Minogue noted that the technology will be increasingly simplified, requiring only limited monitoring, and constantly refined to allow a greater range of everyday tasks and mobility.

In sum, Minogue says that the controlled roll-out of the AbioCor is an “obligation.”

“As the company with the only artificial [totally implantable] artificial heart, we won't try to rush to market or over-extend.” The goal is “going home and enjoying life.”

Though the economics of the AbioCor are likely to be difficult – and made more difficult by continuing R&D costs, Minogue acknowledged – the device will be “a profit center,” he asserted. While he declined to place any timeline on achieving profitability, this goal will be bolstered at some point with rollout of the company's next generation of the AbioCor, its smaller size allowing implantation in more people and perhaps – it is hoped – in women. For the AbioCor 2, he said, the goal will be to extend patient life for up to five years, with a per-day cost of about $200.

Minogue projected first-in-man implants for the AbioCor 2 in 2008, though it hasn't been determined whether this will come via another humanitarian device exemption or a clinical trial in support of premarket approval.

While success with the AbioCor will garner for the company continued headlines, Minogue repeated Abiomed's primary goal: sending patients home “with their own hearts,” thus underlining the company's growing portfolio of heart support devices.

“Before we were a one-product company,” Minogue told MDD. “Today, we're a real company with a portfolio of products addressing the No. 1 killer, acute heart failure.”

Paralleling the gradual roll-out for the AbioCor, Minogue added: “We are conservative in our guidance. For this year, we will lose money, but we'll grow to about $52 million in revenue.”