Medical Device Daily Washington Editor

WASHINGTON – Today begins two days of hearings being held by the FDA’s Circulatory System Devices Panel on cutting-edge technology in the cardiovascular sector.

Today’s hearing will focus on the premarket approval application (PMA) from Acorn Cardiovascular (St. Paul, Minnesota) for its CorCap Cardiac Support Device (CSD) device, a mesh wrap that is placed around the heart to stop enlargement caused by heart failure.

Thursday’s session is expected to produce panel recommendations on a much-anticipated humanitarian device exemption (HDE) for the AbioCor artificial heart from Abiomed (Danvers, Massachusetts). It is the first completely implanted artificial heart to be reviewed by the FDA, the company said.

An HDE application is similar to a PMA application, but exempt from the effectiveness requirements of a PMA. Ultimate approval will provide commercialization for a population of 4,000, many more than possibly can be treated by the device, given the stringent parameters defining the appropriate patient pool.

Today’s meeting will include a presentation by both Acorn and the FDA, including a discussion of updated results from the Acorn Clinical Trial, conducted to evaluate the safety and effectiveness of the CorCap.

Acorn says the CorCap is the first medical device specifically designed to address the problem of cardiac enlargement by providing direct support to the heart and improving the heart’s structure. The device’s mesh material is proprietary to Acorn, and is placed jacket-like around the heart via a surgical procedure.

The company has emphasized the need for its device, given that heart failure affects more than 5 million people in the U.S. and 25 million worldwide.

According to Douglas Mann, MD, a cardiologist affiliated with the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine (both Houston), CorCap is most effective for “moderate cases of heart failure patients,” particularly those not doing well on medical therapy.

Mann presented clinical trial results during the American Heart Association (AHA; Dallas) annual meeting last November. He also will be presenting during today’s panel meeting.

He said 1 million to 1.5 million of the 5 million heart failure patients in the U.S., could benefit from the CorCap technology. “It fits a middle ground,” he said, since it does not rule out later interventions such as heart transplant and is “synergistic” with other medical therapies.

An HDE approval would mark a very large end-point/starting point milestone for the commercialization of Abiomed’s AbioCor technology. At the time of the HDE filing last September, President and CEO Michael 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.”

Javier Jimenez, Abiomed’s vice president of operations, recently told Medical Device Daily that if the device wins HDE approval, the company would 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 smaller and is projected to be a five-year device vs. the two years projected for the original system.

“We believe that this panel will give us immediate exposure to the experts in heart failure, as well as the general public,” said Minogue, who was recently named to the added post of company chairman (MDD, June 16, 2005). “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.”

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 receive donor hearts every year. This consistent shortage demonstrates the need for an alternative to heart transplantation, the company says.

Minogue said Abiomed 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 – which essentially is being used in this case solely for end-stage life support – Jimenez said the company intends to “have some sort of economic evaluation when we present in front of the [FDA] panel.”

AbioCor I is designed to sustain the body’s circulatory system and to extend the lives of patients who would otherwise die of heart failure. Unlike older generations of artificial hearts, AbioCor patients are not attached to a large air-pumping console, and they don’t have wires or tubes piercing their skin.

The device is driven by an electro-hydraulic system pumping that provides consistent and stable circulation, similar to a patient’s natural heart, the company said. This device also contains a microprocessor chip and internal diagnostics designed to continuously monitor a patient’s vital signs.

Both hearings are being held at the Hilton Washington DC North in Gaithersburg, Maryland.