Medical Device Daily Associate

Abiomed (Danvers, Massachusetts) last week reported that the FDA has granted approval for it to begin a pilot clinical trial immediately in the U.S. for the Impella 2.5 minimally invasive ventricular assist device (VAD).

The indication for use is support during “high-risk” angioplasty for up to five days as a left ventricular assist device. The company said the approval is conditioned upon the company's submission of additional information to the agency over the next 45 days.

High-risk angioplasty is defined as patients undergoing angioplasty on an unprotected left main coronary artery lesion, or the last patent coronary conduit, and poor cardiac function.

Michael Minogue, president, CEO and chairman of Abiomed, told Medical Device Daily that if and when this new system is finally approved in the U.S., it will fit nicely into the company's shifting emphasis from a replacement strategy – via the not-yet-approved Abiocor implantable artificial heart – to one of allowing the patient's own heart to recover with assistance.

While he noted that the angioplasty opportunity is important, “part of the biggest opportunity for the patient population is for those suffering from heart attacks that go into cardiogenic shock.”

He said about one million people in the U.S. suffer a heart attack every year, and about 70,000 of these go into cardiogenic shock. “About half of those people are dead within six months,” he said.

Abiomed acquired the Impella technology in an acquisition last year via its buy of Impella CardioSystems (Aachen, Germany), in a transaction that could, with milestone payments, range up to $29 million (MDD, April 28, 2005). The Impella line of devices, which also consists of a 5 liter flow version of the device as well as the 2.5 liter version, already have the CE mark.

At the time of the acquisition, Abiomed described Impella as manufacturing “the world's smallest, minimally invasive, high-performance micro blood pumps with integrated motors and sensors for use in interventional cardiology and heart surgery.” These devices are used in the cath lab and are inserted percutaneously, much like a standard balloon pump procedure, to help restore blood flow.

Perhaps the most important thing about getting the Impella approved, Minogue on Friday told MDD, would be to provide the company with market inroads into the catheterization lab.

He noted that most acute myocardial infarction (AMI) patients go through the cath lab. “That is the most frequent path they follow.”

He said that when these AMI patients come in they present with muscle damage to the left ventricle of the heart. Rather than dying outright, these muscle cells go into a stunned or “hibernation” mode.

With the Impella, the electrophysiologist in the cath lab “will have the capability to start blood flow for patients that are in heart attack,” Minogue said.

With the new opportunity in angioplasty, he noted that the recovery path can start now earlier in a minimally invasive fashion for the company.

“From a high risk PCI [percutaneous coronary intervention], we are now with patients we were not with before, so it expands our market opportunity and it helps interventional cardiologists get familiar with our Impella technology on a scheduled basis rather than with the emergency 1 a.m. heart attack.”

Minogue pointed out the importance of the Impella system to his company. “It's the first time you're able to get a ventricular assist device into somebody's left ventricle . . . without doing a sternotomy, or requiring a heart-lung machine or even an operating room,” he said.

“The Impella 2.5 is a highly advanced, minimally invasive VAD that can be utilized in the cath lab to provide patients support during a procedure,” said William O'Neill, corporate director of cardiology at William Beaumont Hospital Royal Oak, Michigan). “We hope to demonstrate that the Impella system, with its unique capability to unload the left ventricle and enhance flow to the body, will improve the safety of complex, high-risk angioplasty procedures.”

The company said it intends to conduct the pilot investigation on the Impella 2.5 with no more than seven hospitals and 20 patients. Based on the Centers for Medicare and Medicaid (Baltimore) category B2 status, it noted that the participating hospitals could be eligible for full reimbursement during the trial. The company said it will conduct a conference call in the future to outline the details of the trial.

While Abiomed continues to focus more of its resources on the recovery of the heart, Minogue told MDD that the company has not given up hope on the AbioCor implantable replacement heart, the product that first attracted attention to the company a few years ago.

In June 2005, the FDA's circulatory panel voted that the company's humanitarian device exemption [HDE] did not meet the criteria set forth for that application (MDD, June 24, 2005). That same FDA panel, however, provided a ray of hope for the company when it turned down a “non-approvable” recommendation.

The company originally submitted the AbioCor to the FDA in September 2004 for marketing approval under an HDE. Approval under an HDE would make the device commercially available to treat a defined subset of not more than 4,000 irreversible end-stage heart failure patients.

“What we're [now] waiting for is the final decision from the FDA on whether or not they're going to approve or disapprove the AbioCor humanitarian device exemption.” He added that the company “hasn't given up on [the AbioCor] at all.” Rather, he noted that the company has moved the device into 10 dedicated centers in the U.S., the same ones that will also get the AbioCor II.

“We believe there's a need for it, there is no other alternative for somebody who has ventricle failure on both sides and needs support,” Minogue said.

He said the goal with the specialized AbioCor is to have it available at a few centers “that are dedicated to it,” as opposed to, say, the hundreds of hospitals that have open heart centers in the U.S., for example.