CDU

The majority of those reading this issue of Cardiovascular Device Update undoubtedly will recognize the name Barney Clark, and perhaps remember his nearly heroic status in the history of medical technology. Clark, a 50-year-old retired dentist, was the person who was so widely documented as the recipient of the first artificial human heart, the Jarvik-7, in 1982.

Just as many readers are likely to recognize the name Leon Lederman, the founder of Abiomed (Danvers, Massachusetts) and the person who over the last 20 years was considered an aggressive pioneer — or certainly the most publicized — in the effort to move artificial heart technology into clinical use.

Fewer readers are likely to recognize the name Robert Tools, who could well be considered another hero on the path to the totally implantable artificial heart. Tools was the first person implanted in the 15-patient trial of Abiomed’s AbioCor in July of 2001. He was implanted at Jewish Hospital in Louisville, Kentucky, and lived until late November of 2001, supported by the heart 151 days.

There are many others that could be named as part of this quest — for instance Paul Winchell, who in 1963 received a patent for the first artificial heart. Winchell then assigned the patent to the University of Utah, and Robert Jarvik used it as the model for the Jarvik-7.

Thus this achievement represents more than 40 years of work, with the AbioCor representing a clear case study for understanding what brings about modern scientific advance — such as a vaccine, an antibiotic, a radioactive-fueled cancer-killer, or anything that radically battles disease — to clinical use. They are a building up of people and circumstances in a consecutive string of happenings resulting from a lengthy variety of efforts, both mundane and heroic.

But the culmination of this lengthy effort is, of course, just a big multi-mile marker on what will be a continuing journey. That was the tacit acknowledgment of Mike Minogue, president/CEO of Abiomed and successor to Lederman, following announcement of the FDA approval of the AbioCor.

Besides enjoying a big moment for the company, Minogue also readily acknowledged -- probably not the best news for stockholders --- that a large amount of work lies ahead before AbioCor moves from the first implant of the heart in a clinical trial to the first implant in its commercialization phase under the humanitarian exemption approved by the FDA.

It will take from 6 to 8 months to go back to the clinical site centers and get them regeared up to do more implantations. Minogue gave CDU no timeline for getting to the implants after ramping up is complete, but it is our guess that those first truly groundbreaking implants won’t come until 2008. Late 2007 would be a surprise, and mid- to early 2007 would be miraculous — especially miraculous since Minogue basically committed the company to a highly controlled roll-out of the AbioCor. That isn’t just a good business decision — it is a very good clinical decision. There is a good deal of hope invested in this device, as well as a great deal of time and money.

Especially hope by the person on the verge of death, with the possibility of living additional weeks and months to be with friends, family, perhaps grandchildren. And doing so not just as someone bed-ridden, vegetative, but as a productive contributor to life, the primary goal of Abiomed, according to Minogue. He emphasizes that the purpose of the AbioCor is to offer not just life support but quality-of-life support. But Minogue also would provide no predictions of the numbers to be implanted, either short-term or long-term.

But if a medical technology can be faulted for having too many variables to achieve success, this is it. Compared to the difficulties of finding the patients most appropriate for AbioCor implantation, the surgical procedure to implant the device is a snap. The difficulty is in finding the patient with a large imbalance in systemic disease — an extremely sick heart but with other functions either in relatively good shape or amenable to some recovery — if not complete rehabilitation provided by the new heart itself.

Other considerations include body size (most women are not physically large enough). Then there are all sorts of drug issues to be considered in terms of anti-coagulation and the necessary complementary drugs — just as there was with heart transplantation. And the myriad of these difficulties is no doubt the reason why the company didn’t complete the final patient in the trial (and the FDA agreeing that work done was work enough for approval).

The AbioCor approval offers another case study that would be instructive for any entrepreneur wanting to get into the medical device sector.

It will be difficult gearing up for and then moving into multiple implants, but it will, we think, be incredibly more difficult and complicated to win that all-important reimbursement coverage from the Centers for Medicare and Medicaid Services. Minogue told CDU that CMS does frequently approve technologies that essentially lose the system money — thereby suggesting that this could be the case for AbioMed. But he said that the company’s argument is that the AbioCor is intended to save the system money. He argued that, compared to the costs for drugs to sustain patients into the very last stages of life — and quite often, beyond — the cost of the AbioCor, the implantation procedure and patient after-care and monitoring is less expensive. The costs of the device and procedure are fairly available; the cost of after-care is extremely unpredictable, though Minogue argues that the basic costs here will end up being fairly negligible, through automation and increasingly advanced systems to come.

That may be, but we predict it is going to take a lot of experience with the heart, in a lot of patients, with a high level of documentation to support the company’s argument. Can the AbioiCor become what Abiomed wants it to be — not just a life support alternative but a tool that improves health for the very sick heart patient?

We have no idea what the final days of Robert Tools were like, supported by the AbioCor. We don’t know if he was happier with the additional days of life, or if they were filled simply with the continued anxiety that must accompany the expectation of now, even-more-certain death. And what was the sum total of this experience for his family while he was supported by the heart and after his death?

We don’t know this — just as most people won’t know the name Robert Tools — because of the public information policy that Abiomed adopted early on. It clearly took a page out of Barney Clark’s story and the media circus that surrounded his support with the Jarvik. While the media coverage initially haled the procedure as a medical miracle, the coverage of his rather painful last days probably left the impression in most minds that this was just another medical experiment gone bad.

Thus, Abiomed gave out the barest minimum of detail concerning the procedure and the patient — the implant had taken place at a particular hospital, by certain doctors, and a mere sentence about patient condition. The rationale could hardly be disputed — that the company wanted to avoid any possible distraction from patient care. Of course, it also served the happy purpose of avoiding prying journalistic eyes which might ferret out a host of the inevitable family and patient complaints, and encourage a host of doubters (many in the person of shareholders).

CDU of course hopes that Abiomed will alter that policy in the early commercialization process. And we think it will. The company will have to be much more open about a commercialized product — first of all, because if it is a product being sold to the public, for this amount of money and the large amount of clinical uncertainty, there must be frequent disclosure concerning risks, not just benefits.

Finally, whatever Abiomed’s policy, we would suggest that investors are likely to stick with this company — not because of the AbioCor, but because it shows the capacity to make solid management decisions.