The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year.
HeartWare was approved based on data from the pivotal ADVANCE trial, in which 140 patients received the Heartware device and were compared to historical controls who had received Thoratec’s HeartMate II device. The FDA said this was the first time it had approved an LVAD using registry data as a control. Unlike Thoratec’s HeartMate II VAS, which is surgically implanted in an abdominal pouch, the HeartWare VAS is implanted next to the heart.
The FDA said that surgical outcomes were comparable in the two groups. Because of the risk of stroke associated with the device, the FDA said patients and clinicians should “discuss all treatment options before deciding to use the device.”
HeartWare said that the FDA was requiring the company to perform a post-approval study in the form of a registry consisting of 600 HeartWare patients and an additional 600 control patients. The FDA will also require sites that implant the device to undergo training with an approved program.
Here is the FDA press release:
FDA approves pump for heart failure patients awaiting heart transplant
The U.S. Food and Drug Administration today approved the HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.An LVAD is a mechanical pump used to support heart function and blood flow in people who have weakened hearts. LVADs are the most common type of ventricular assist devices, and they help the heart’s left ventricle pump oxygen-rich blood to the body.The HeartWare System includes an implantable pump with an external driver and power source. It is designed for use inside or outside the hospital.“For patients awaiting a donor heart, the HeartWare System provides a new treatment option,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.Other available LVADs require components to be placed in the abdomen. The HeartWare System is small enough to be implanted in the chest near the heart, allowing for implantation in smaller adults or patients unable to have an implant in the abdomen. The life-saving benefits of the LVAD in the intended patient population outweigh the risks observed during the clinical trial.The FDA approved the HeartWare LVAD based on data from a clinical trial known as the ADVANCE trial. The trial compared outcomes from 137 advanced heart failure participants using the HeartWare System with outcomes from similar patients followed by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).Survival outcomes were comparable in the HeartWare LVAD and INTERMACS groups. Key serious adverse events such as infection and stroke were assessed in the clinical trial and compared with adverse events discussed in the scientific literature based on clinical trials or postmarket studies of other LVADs. Although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device.This is the first time the FDA has approved an LVAD using registry data as a control. The INTERMACS registry collects information on patients implanted with approved mechanical circulatory support devices (MCSDs). The INTERMACS registry was established in 2005 as a joint effort involving the FDA, National Heart, Lung and Blood Institute (NHLBI), Centers for Medicare and Medicaid Services (CMS), clinicians, scientists, and industry. INTERMACS is managed by the University of Alabama at Birmingham.“Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators. For HeartWare, registry data directly facilitated the development and availability of this new device,” said Foreman.Heart failure occurs when the heart is unable to pump blood normally throughout the body. Factors that can lead to heart failure include high blood pressure, narrowing or blockages in the heart’s blood vessels, and heart infections. Heart failure is considered end-stage when the underlying condition remains severe and no longer responds to medical therapy or other treatment options. Those with end-stage heart failure may need a heart transplant to survive. LVADs can be used as a “bridge” therapy for these patients until a suitable donor heart becomes available.The HeartWare Ventricular Assist System is manufactured by HeartWare Inc. of Framingham, Mass.For more 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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