FDA expands labeling of Medtronic's CRT pacing system for heart patients

By Lisa Kerner

Erie, Pa., March 16 - Medtronic, Inc. said the Food and Drug Administration granted clearance for expanded labeling of the company's cardiac resynchronization therapy biventricular pacing systems.

The labeling expansion is based on the results of Medtronic's clinical study known as CARE-HF (Cardiac Resynchronization in Heart Failure), according to a company news release.

Medtronic said CARE-HF showed that cardiac resynchronization therapy reduces hospitalizations and saves lives in many patients with moderate or severe heart failure and poor heart pumping function, reducing mortality by 36% and unplanned hospitalizations for worsening heart failure by 52%.

In cardiac resynchronization therapy, electrical impulses are sent to the heart muscle to resynchronize heart contractions.

CARE-HF is a prospective, multi-center, randomized study of patients with a poorly functioning left ventricle and receiving optimal heart failure medical therapy, such as ACE inhibitors and beta blockers.

Investigators followed 813 patients at 82 clinical centers in 12 European countries. A Medtronic InSync or InSync III cardiac resynchronization therapy device was implanted in 409 patients, with 404 patients were in the control group.

The average three-year randomized results showed a 40% reduction in all-cause mortality, 45% reduction in heart failure death, 45% reduction in sudden cardiac death, and a sustained improvement in the heart's pumping function.

The study results were presented at the American College of Cardiology Annual Scientific Session and published in The New England Journal of Medicine.

"This is great news and absolutely appropriate given the overwhelming evidence in support of CRT [cardiac resynchronization] therapy," director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center Dr. William T. Abraham said in the release.

"The revised labeling, which considered the CARE-HF data, provides further validation that CRT and CRT defibrillator systems should be routinely used in patients with moderate to severe heart failure."

Medtronic, Inc., based in Minneapolis, provides medical technology to alleviate pain, restore health and extend life.

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