FDA Panel Backs Implant for Mild Heart Failure

HEALTH Tens of thousands of patients previously ineligible for the Boston Scientific heart-regulating device should soon qualify. A panel of cardiologists acting as advisors to the Food and Drug Administration (FDA) unanimously approved the device, known as a cardiac resynchronization therapy defibrillator, with the assurance that the company tracks long-term patient safety. Though the FDA will make its final decision by mid-June, it generally supports panel recommendations, especially when there are obvious benefits.

An integrated defibrillator, which shocks the heart to correct irregular beats, and a resynchronization device, which coordinates heart pumping, are combined in one device. Most heart failure patients currently receive only a defibrillator.

Boston Scientific Corporation showed that patients implanted with the resynchronization defibrillator were 34 percent less likely to be hospitalized or experience other heart-related events when compared to patients who only received a defibrillator. No difference in death rate between the two groups was reported. Nevertheless, panelists said the reduction in hospitalizations was enough to warrant approval.

Tags: cardiology, clinical study, equipment, geriatrics, surgeons, technology


Read complete 2010 article from Associated Press retracted.