Medical Device Daily Associate

Abiomed (Danvers, Massachusetts) moved a step closer to an approval for its experimental artificial heart with the disclosure that the FDA will convene an expert panel of cardiovascular surgeons and cardiologists to consider the company’s humanitarian device exemption (HDE) submission.

The special expert review panel is slated to decide on June 23 on the potential approval for the AbioCor, which the company has billed as “the first-ever completely self-contained artificial heart to come before the FDA for review.”

The company originally filed its HDE application with the FDA last September (Medical Device Daily, Sept. 9, 2004).

“We believe that this panel will give us immediate exposure to the experts in heart failure, as well as the general public,” President and CEO Michael Minogue said in a company statement. “Our surgeons are very passionate about this technology and look forward to having the ability to offer this solution under an HDE to their patients.”

Javier Jimenez, vice president of operations, told Medical Device Daily that if Abiomed gets its HDE for the device it will do a “very controlled rollout, with only up to 15 centers that will be doing procedures with this device.”

After that, he said the company plans to focus its attention on the next-generation AbioCor II device, which already has been implanted in animals and is slated for clinical implantation in humans by the end of 2007.

The newer iteration of the device will be 35% smaller and is projected to be a five-year device vs. the two years projected for the original system.

The same 15 centers involved with the studies for the first-generation product will also be involved in the AbioCor II studies, Jimenez said.

Under a 15-patient investigational device exemption (IDE) study, 14 extremely ill patients have been implanted with the original AbioCor device, though all have since died – the last one this past November (MDD, Nov. 8, 2004).

Among the 14 implanted, the patient who lived longest survived for 17 months and lived at home for more than one year.

While the IDE study has not yet been completed, Abiomed said it is not required to enroll a 15th patient before submitting for approval under an HDE, since completion of the initial clinical trial is not a prerequisite for such a submission.

The company has been involved in a very lengthy IDE study – which began with the first AbioCor implant in Robert Tools at Jewish Hospital (Louisville, Kentucky) on July 3, 2001 – in order to gain premarket approval for a destination therapy indication from the FDA, which could potentially have opened the product up to an even larger patient population, a goal that the company still hopes to achieve with the AbioCor II.

In order to qualify for implantation of the device under the much less stringent HDE protocol, patients must suffer from biventricular heart failure, be ineligible for a heart transplant and have a high probability of dying within 30 days.

At the time of the HDE filing in September, Minogue told MDD than an HDE approval would likely be the endgame for the first generation of the AbioCor, which costs about $250,000 for each device.

“I think the HDE is a huge accomplishment and is likely what we’re looking for as the final result on the AbioCor I,” he said, adding that the 4,000 destination therapy patient figure granted under the HDE is four to six times smaller than the current patient population for the device. Once the company gets to the AbioCor II, Minogue said, “then you have the capability of a larger-scale ramp-up.”

In September 2003, Abiomed received approval from the FDA to designate the AbioCor as a humanitarian use device, a mandatory step preliminary to filing for an HDE. At the time of that designation, the company said it hoped to receive an HDE in the second half of 2004.

The company said the technology behind the AbioCor artificial heart is the result of more than 20 years of design, research, and testing conducted by it and its collaborators, with the support of the National Heart, Lung and Blood Institute (Bethesda, Maryland).

The AbioCor is designed to sustain the body’s circulatory system and to extend the lives of patients who would otherwise die of heart failure. Its design allows it to be totally implanted within the body. Unlike the artificial hearts of the past, patients are not tethered to a large, air-pumping console nor do they have wires or tubes piercing their skin.

The device is driven by an electro-hydraulic system pumping seamlessly to drive consistent and stable circulation, similar to a patient’s natural heart. This device also contains a microprocessor chip and internal diagnostics that are designed to continuously monitor patient vitals.

Although the company noted that “tens of thousands” of patients are in need of a heart transplant, only about 2,000 people in the U.S. will be able to receive donor hearts every year. This consistent shortage, in the supply of donor hearts in the U.S., the company said, demonstrates the need for an alternative to heart transplantation.

The company believes the pricey device, one of many that some experts say are driving double-digit health inflation, has an important place in the healthcare pantheon.

Abiomed, Minogue said, is helping medical centers with cost models to convince employers and government payers that in some cases implantation of its device would still be cheaper than extended hospital stays in an intensive care unit, another important healthcare cost driver.

“Some of [these patients], if they are younger, could end up spending 200 days in the hospital,” he said.

While the company has not publicly released a cost/benefit analysis that could bolster its case for government reimbursement of the system – essentially being used in this case solely for life support. Jimenez said the company intends to “have some sort of economic evaluation when we present in front of the [FDA] panel.”

Jimenez emphasized that the AbioCor isn’t the only product that the company has in its arsenal. In fact, he said Abiomed’s priorities have shifted somewhat recently. “I think we’re expanding the focus of the company,” he said, adding that “[Abiomed] was originated with a vision of coming up with an artificial heart but along the way, some of the technology and some of the inventions that went into the AbioCor have benefited some of the other technology.”

Some of these devices that have benefited from the AbioCor technology include “bridge-to-recovery” products that the company is already selling including the BVS biventricular support system, and the AB5000 circulatory support system.

“What we’ve been able to do is leverage all the technology and the millions of dollars invested in the AbioCor to be able to expand to other areas,” Jimenez said.