Heart activity -- or the lack of it -- is detected by electronics that give "three different angles of looking at the heart," Bardy explained. The device is capable of telling the difference between electronic abnormalities that originate in the heart vs. those that occur outside the heart.
In the two trials reported in the journal, the implanted defibrillator successfully detected all 137 instances of the potentially fatal abnormal heartbeat called ventricular fibrillation. A larger trial that will implant 340 of the devices is now enrolling participants, Bardy said.
"The results will be given to the [U.S.] Food and Drug Administration in the summer of 2011," he said. "Then it is up to the regulatory authorities."
The defibrillator already is in use in several European countries, added Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago. He took part in the trials that led to European approval and is participating in the new trial.
"There is no question that the entire system, from implanting to programming to postoperative care for patients, is simpler," Burke said.
The new device might even reduce the cost of implanted defibrillators, both Bardy and Burke said.
Implantation of existing defibrillators now requires expensive fluoroscopy screening, Bardy said. "The new one doesn't need fluoroscopy and can be installed in 30 minutes," he said. "That will whittle away at the cost dramatically, and because complications now occur in 10 percent of cases, it can cut costs by eliminating those complications."
The new defibrillator is implanted alongside the sternum, the chest bone, in a much simpler surgical procedure than is now needed, Bardy said. And if something should go wrong, "removing it is relatively minor surgery compared to removing of one that breaks while an electrode is in a ve
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