Tests of Heart Devices to Get Review

-NY Times

10/18/2007- The Food and Drug Administration is likely to study whether to require more extensive tests of critical heart-device components before they are sold, as a result of Medtronic’s recent problems with such a product, an agency official said yesterday.

“We are going to be looking at this to see whether the failure can help us design better tests,” said the official, Megan Moynahan.

Ms. Moynahan, a branch chief at the F.D.A.’s Center for Devices and Radiological Health, said the agency would examine whether the stress tests it currently required were sufficient to catch problems with the leads, or electrical wires, that connect implanted defibrillators to the heart. A defibrillator is designed to give a jolt to an erratically beating heart to return it to a normal rhythm.

On Sunday, Medtronic urged doctors to stop using a family of leads called Sprint Fidelis because they were prone to cracking, with potentially life-threatening consequences like firing repeatedly and unnecessarily, or not sending a jolt when needed.

The company has said it thinks at least five patients might have died because of the flaw and that 4,000 to 5,000 patients would encounter problems with the leads, which would force them to undergo potentially risky replacement procedures. An estimated 235,000 patients are thought to have Sprint Fidelis leads.

Questions have been raised both about whether Medtronic acted quickly enough in stopping use of the leads and about whether the agency sufficiently scrutinized the Sprint Fidelis before approving it in 2004 and after it reached the market.

Late Tuesday, Senator Charles E. Grassley, Republican of Iowa, sent letters to officials at Medtronic and the agency that he wanted them to meet with members of his staff to discuss their handling of the situation.

“What I found troubling is that Medtronic took months to stop the sales of the faulty lead, even though the problem had been reported in a peer-reviewed journal months prior,” he wrote to Medtronic.

Officials of Medtronic, which is based in Minneapolis, have insisted that they acted prudently and halted sales of the product even though they said the data they had about the product’s fracture rate was equivocal.

Dr. Robert J. Myerburg, a professor of medicine at the University of Miami who headed an outside panel that issued a report in 2006 that was highly critical of Guidant’s handling of problems related to defibrillators, said it was difficult to judge how Medtronic handled the issue without knowing more information. For example, Dr. Myerburg said he would want to know how the company’s anticipated rate of failure for the Sprint Fidelis compared with the reality.

A Medtronic spokesman has said it anticipated that the Sprint Fidelis would perform at least as well as older leads.

As for the F.D.A., Ms. Moynahan said that although the agency had required Medtronic to test an earlier version of a defibrillator lead in patients before approval, it had not required the company to do so for the Sprint Fidelis. That was because it the agency had determined that the Sprint Fidelis was not a significant, or “generational,” change in product design, she said.

The Sprint Fidelis lead is thinner than the earlier version, the Sprint Quattro, which has performed very well. Several experts have said the thinner design of the Fidelis model is probably what makes it less durable and more prone to fracturing.

Before approving it, the agency did not require clinical testing of the Fidelis. Ms. Moynahan said she believed that clinical tests would not have identified the problem, because the number of patients in the study group would have been too small and because the fracture problems developed well after implantation.

Instead, the F.D.A. required the product to pass only tests intended to identify design flaws. Those were principally mechanical stress tests meant to recreate the pressures in the body.

Because the Fidelis passed those tests, Ms. Moynahan said, the agency must review why the tests did not pick up the problem.

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