FDA approves wider use for heart device

July 19, 2002 — The U.S. Food and Drug Administration said it has expanded the use of Guidant Corp.’s implantable heart devices.

The implantable cardioverter defibrillators (ICD), which contain MEMS-based accelerometers to monitor the body’s activity level, had been approved for patients who had suffered heart attacks and undergone invasive electrical testing. The ruling means many heart attack survivors with impaired heart function are eligible for the devices without the tests.

“It’s still going to be up to your doctor, but the doctor has new guidelines now,” said Annette Ruzicka, Guidant’s manager of corporate communications for cardiac rhythm management. “It really just makes it lots easier for a physician to identify at risk heart attack survivors.”

The federal approval is based on the findings of a clinical trial sponsored by Guidant that showed a 31 percent reduction in the risk of sudden death by those who had the pager-size device implanted. The ICDs detect fatal heart rhythms and treat them by shocking the heart back into a normal rhythm.

Shares in Guidant closed at $31.30 on Friday, up 8.61 percent from the previous day’s close of $28.82.

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