FDA-Approved Artificial Heart From Abiomed a Whimper, Not a Bang

September 8, 2006

The mission of MedTech Futures, which appears on MidwestBusiness.com every other Monday, is to provide insights into developments in the medical technology and health-care scene in the Midwest as well as globally.

CHICAGO -- The FDA on Tuesday approved the world's first self-contained artificial heart in a ruling that was hailed as a "major step forward in a 40-year quest" by agency officials. Echoing those sentiments, Daniel Schultz, director of the FDA's Center for Device Evaluation & Research, declared it "an important milestone" in the field of organ transplantation.

However, Schultz added: "Hopefully down the road it will be better technology and more affordable technology." This last comment seems a little odd considering he was speaking on behalf of the agency that just approved the device and he also heaped some profound superlatives on it. So what can we expect from self-contained artificial hearts -- and, more generally, artificial organs -- in the coming years?

At first blush, it would not seem like much. The grapefruit-sized, titanium and plastic device is called AbioCor and is manufactured by Abiomed. Abiomed was founded in 1981 and is one of nearly 36 companies that have entered the race to develop an artificial heart. In several respects, this is a first-generation device. First and most important, it has not been shown to extend patient life very long.

The 14 men who received the two-pound artificial heart in the pivotal clinical study lived about five months on average after surgery. Only one was discharged from a hospital to live at home. From an engineering standpoint, the device is designed to last for only 18 months.

A second and related issue is the associated risks of the device. Many patients in the study suffered from bleeding complications or died of a stroke. In fact, its dubious benefit/risk profile is what the FDA advisory panel cited a year ago when it voted seven to six against approval. In a rare split with the advisory panel, the FDA approved it any way.

To their credit, the Danvers, Mass.-based device maker has taken steps to address some of the safety concerns. For example, the device was redesigned to mitigate problems with blood clots forming in a section of the device that made contact with the body's tissue.

The company has also focused on identifying patients who may be able to withstand anti-clotting medications to reduce the risk of stroke. Since the device will be made available to only five to 10 centers in the U.S., you can expect the patient to receive treatment in centers that have specialized facilities and high levels of expertise in heart transplantation.

Of course, the end result of a highly stringent patient selection process and a low number of available treatment centers is that very few patients will actually get the procedure. Under the conditions of the FDA's "humanitarian device exemption" approval, no more than 4,000 patients can receive the device annually.

Considering there are about 40,000 to 50,000 people per year who might need a heart transplant, this is an extremely low number. In the case of AbioCor, however, the device is not even expected to come close to that already minimal level. While Abiomed declined to estimate the actual number of patients who might be implanted with the device, an FDA spokeswoman estimated it would be only 25 to 50 patients per year.

Like anything else, price and efficacy matter. The challenge for Abiomed now is to obtain insurance coverage for the device.

According to company chairman and CEO Michael Minogue, slowly dying heart patients in intensive care units cost insurers an average of $1 million in the last six months of their lives. This is a figure that could be cut sharply if they could be sent home. Abiomed is also working on the next generation of the device, which is estimated to be more than 30 percent smaller and last as long as five years.

These immediate challenges may be relatively insignificant compared to those implied by Schultz' statement that "hopefully down the road it will be better technology and more affordable technology." What this means is there are many who believe -- even those who have approved the device -- that this is a "transition" technology destined to be replaced by something more sustainable.

It would seem that Abiomed itself is hedging its bets. As noted in Thursday New York Times article headlined "An Innovative Heart Device is Still Short of Lucrative," Abiomed decided several years ago that it needed to shift gears and spend more of its resources on developing devices to assist failing hearts as opposed to ones that could replace them entirely.

It will be interesting to see how the great promise of stem-cell therapies, gene therapies (which have had some "bumps on the road") and other minimally invasive endovascular devices that can supplement left ventricular function play out. While AbioCor is a great advance and certainly glamorous on the surface, in the large scheme of things -- individual patient benefit notwithstanding -- it is more of a "whimper" rather than a "bang".

Dr. Ogan Gurel is CEO of Duravest, a Chicago-based medical technology investment company that invests in and develops next-generation medical technologies. Dr. Gurel is also president elect of the Chicago Health Executives Forum and is on the adjunct faculty at Roosevelt University where he teaches bioinformatics and mathematical biology. He can be e-mailed at ogan@ogangurel.com.

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This article posted September 23, 2006.