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FDA NEWS RELEASE
For Immediate Release: April 10, 2014
Media Inquiries: Susan Laine, 301-796-5349, firstname.lastname@example.org
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FDA approves expanded indication for certain pacemakers and defibrillators used to treat heart failure
The U.S. Food and Drug Administration today approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.
About 5.1 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs. With proper treatment and lifestyle changes, people with heart failure can live longer and more productive lives.
The CRT-P and CRT-D devices (see complete device list below) work by providing electrical impulses to the right and left sides of the heart through implanted leads to the heart’s right ventricle (RV) and left ventricle (LV). 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 RV leads used with CRT-D devices are also capable of delivering high voltage energy to defibrillate the heart in the event of ventricular arrhythmia.
The FDA previously 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 RV pacing. With the new indication, these patients will be 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 Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “This approval expands the indication of cardiac resynchronization therapy to this additional patient population.”
The expanded approval for the CRT-D and CDT-P devices was based on data from the Block HF clinical study that compared death, heart failure-related urgent care visits and increases in left ventricular end systolic volume index (LVESVI) in study subjects who received either left and right ventricular pacing, or right ventricular pacing alone. LVESVI is a diagnostic measure of cardiac structure and function. A total of 918 subjects participated in the trial, 531 of whom received a CRT-P device and 227 of whom received a CRT-D device. The study showed that the cardiac resynchronization therapy provided by CRT-P and CRT-D devices results in a 27 percent reduction in death, heart-failure-related urgent-care visits, and increases in LVESVI compared to right ventricular pacing alone.
The expanded device approvals are for the following devices manufactured by Medtronic:
Maximo II CRT-D
Concerto II CRT-D
Viva XT CRT-D
Viva S CRT-D
Protecta XT CRT-D
Medtronic is headquartered in Minneapolis, Minn.
For more information:
FDA: Medical Devices
NHLBI: Heart Failure
NHLBI: Types of Arrhythmias
FDA: Cardiovascular Information
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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