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Expanded indication for certain pacemakers and defibrillators approved by FDA

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The FDA has announced its approval of Medtronic’s application for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D) allowing them to expand use for patients with atrioventricular (AV) block and less severe heart failure.
The Food and Drug Administration has already approved these devices for patients with more severe heart failure as evaluated by their physician using specific criteria. The new approved use includes patients with less severe heart failure, but who are already indicated to receive right ventricle,now making them eligible to receive a device that will pace both sides of their heart instead of just the right.

“Medtronic’s cardiac resynchronization therapy pacemakers and defibrillators can delay the occurrence of heart failure-related urgent care visits for people who meet these new criteria,” said FDA’s Center for Devices and Radiological Health director of Device Evaluation Christy Foreman. “This approval expands the indication of cardiac resynchronization therapy to this additional patient population.”

The pacemakers and defibrillators work by sending electrical impulses to the right and left sides of the heart through implanted leads to the heart’s right and left ventricles. The timing of the impulses is programmed by a clinician who synchronizes the patient’s heart to improve cardiac function for heart failure patients. The right ventricle leads used with CRT-D devices are also capable of delivering high voltage energy to defibrillate the heart in the event of ventricular arrhythmia.

According to government figures, there are more than 5 million people in the United States suffering from heart failure, a condition in which the heart cannot pump enough blood to meet the needs of their bodies. However, most patients can live longer and more productive lives with “proper treatment and lifestyle changes.”
For more information, consumers can either speak to their cardiologists, orcontact the FDA directly by calling 888-INFO-FDA



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