FDA Approves Heart Device With Jump-Start Mechanism

The Food and Drug Administration on Thursday 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 who will benefit from resynchronization therapy, FDA medical reviewer Helen Barold said.

The Contak CD is for advanced heart-failure patients who are not adequately helped by medication and need a defibrillator.

“It’s very individualized,” Barold cautioned. “It’s a little bit of a last resort for patients.”