By LAURAN NEERGAARD
Monday, May 20, 2002
Washington -- The Food and Drug Administration has approved a new heart implant that combines a souped-up pacemaker to boost the heart's pumping power with a jump-starter that kicks in if the heart stops.
Guidant Corp.'s Contak CD is the first implanted defibrillator with "cardiac resynchronization," a way to make a struggling heart beat more normally by forcing its main pumping chambers to work together.
A resynchronizer is already available from Medtronic Inc., and many companies sell implanted defibrillators that jump-start hearts that suddenly stop beating. Guidant's device is the first to combine the two types of implants.
The caveat: Doctors can't yet tell exactly who will benefit from resynchronization therapy, or how much it will help, said FDA medical reviewer Helen Barold.
The Contak CD is for advanced heart failure patients who are not adequately helped by medication and need a defibrillator. In studies, some of those patients saw their quality of life and tolerance for exercise improve dramatically, while others saw only a little change.
"It's very individualized," Barold cautioned. "It's a little bit of a last resort for patients."
The new defibrillator takes a little longer to put in than traditional ones, she said, because it has an extra lead to snake into the heart.
Almost 5 million Americans have congestive heart failure, in which a heart weakened by age, damage from a heart attack or some other disease gets flabbier as it struggles to push blood out to the rest of the body. Just half of such patients survive five years. When medications fail, a heart transplant is the only option, but many patients die before getting one.
For many such patients, the heart's main pumping chambers don't beat together simultaneously and sap the heart's power. Resynchronizers use wires implanted in different spots to make the chambers pump together as they would in a healthy heart.
Guidant said it will begin selling the new device immediately. The list price will be $44,475 -- about $9,000 more than a regular defibrillator -- but most hospitals don't pay list price and Guidant wouldn't estimate the cost to patients.
Food and Drug Administration: www.fda.gov Guidant: www.guidant.com