Food and Drug Administration expanded the application parameters for a number of defibrillators and pacemakers that are used to treat heart failure.
FDA approved an application from Medtronic, which is a company that manufactures two cardiac resynchronization pacemakers (CRT-Ps) and eight cardiac resynchronization defibrillators (CRT-Ds), to allow patients who have atrioventricular blockage and less severe heart failure to have access to these devices.
Previously, FDA approved these devices for patients who had more severe heart failure as determined by his/her physician. The new approved use includes patients who have less severe heart failure but who already are indicated to receive a pacemaker in the right ventricle. These patients now will be able to receive a device that will pace both sides of the heart instead of just the right.
The CRT-Ps and CRT-Ds provide electrical impulses to the heart that are programmed to synchronize with a patient’s heart in an effort to improve heart function. The defibrillator also is capable of delivering high voltage energy to shock the heart in the event of ventricular arrhythmia, or abnormal heart beats.
FDA says about 5.1 million people in the United States have heart failure, which is a condition where the heart can’t pump enough blood to meet the body’s needs.