By Jeff Karoub
Small Times Staff Writer
July 11, 2001 — Small technology that now helps people maintain a regular heart rhythm in pacemakers soon could be part of a lifeline when the organ fails.
Medtronic Inc.’s InSync implantable pacemaker cleared an early hurdle Tuesday afternoon when a U.S. Food and Drug Administration (FDA) advisory panel
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| Medtronic Inc.’s InSync advanced pacemaker for congestive heart failure is surgically implanted below the shoulder with three wires leading to the heart. Electricity is delivered to restore the heart to its normal rhythm. |
The recommendation means the Minneapolis-based leader in pacemakers is first in line to sell an implanted device designed specifically for heart failure. Its nearest competitor, Guidant Corp., failed to get backing from the same FDA panel for its Contak CD, which combines treatment for heart failure with a defibrillator to regulate heartbeats. Medtronic sells more than half of the implantable pacemakers used in the U.S. Guidant is second in sales.
Panel members expressed concern over Guidant’s study of the Contak CD, which missed its goal of cutting progression of heart failure by 25 percent. In a written statement, Guidant officials said they remained committed to the device and would continue to work with the FDA.
At the heart of all modern implanted pacemakers and defibrillators is a MEMS accelerometer, which monitors the heart’s activity level. The tiny machine works alongside a microprocessor to deliver more electricity to keep the heart in rhythm when levels go above or below the person’s normal heart rate range.
Medtronic makes a device that was recently implanted in Vice President Dick Cheney. The Medtronic GEM III DR, a pacemaker and implantable cardioverter-defibrillator (ICD), now constantly records Cheney’s heart activity and can speed up or slow down an irregular rhythm. And it’s all in a package the size of a small pager.
Medtronic’s device for heart failure uses the same basic system, but it delivers continuous electricity to compensate for low-functioning hearts. InSync, about the size of a half-dollar coin, is surgically implanted near the shoulder with three leads, or wires leading to the heart.
“It will be as efficient as a weakened heart can be,” said Bob Hanvik, a Medtronic spokesman.
“With this device, we’re really looking at such a major improvement in the quality of life for these patients. … We felt there was an immediate unmet medical need.”
An analyst quoted by Reuters news agency predicted the market for such devices could be $1.1 billion by 2005. Hanvik said that’s yet to be seen, but the need certainly exists: The U.S. alone has 750,000 people suffering from heart failure.
Dianna Bash has seen firsthand the results of the heart-failure treatment devices by Medtronic, Guidant and others. She is a nurse manager of the electrophysiology laboratory at the Cleveland Clinic Foundation, which has been part of the clinical trials for the InSync and Contak CD.
“I work in the lab — I see the sudden improvement of blood pressure,” she said. “It’s very noticeable to me. As soon the device is in and working, their blood pressure goes up.”
Bash said she does not know how long it will take before final approvals, but she said she knows of patients who could benefit from it immediately. It goes so far beyond drug therapy, and could one day reduce the need for heart transplants, she said.
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CONTACT THE AUTHOR:
Jeff Karoub at [email protected] or call 734-994-1106.