The US Food and Drug Administration (FDA) approved an implantable pump that supports blood flow for heart-transplant candidates with end-stage heart failure.
The device known as HeartWare Ventricular Assist System is made by HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure. The device is designed to be implanted in the chest near the heart and inside or outside the hospital. The device is intended for use as a bridge to cardiac transplantation for patients that are at risk of dying or have refractory end-stage left ventricular heart failure.
The company’s shares rose 9.2 percent since the announcement.
The FDA said the benefits of the device for this particular patient population outweigh the risks that were observed during the clinical trial. The device provides life saving benefits; however risks observed consisted of infection and stroke.
The device is already approved by the European Union and the Australian Therapeutic Goods Administration (TGA). Currently, over 2,500 heart failure patients have received the pump worldwide.
“FDA approval marks the culmination of an extensive clinical effort and represents an exciting advance in the treatment of late-stage heart failure patients,” Doug Godshall, President and CEO of HeartWare said in a statement. “We wish to extend our most sincere thanks to the patients, and to their families, for participating in the study of this innovative device, and we also are grateful to each of the nurses, coordinators, surgeons and cardiologists who provided care to those patients.”
FDA approval was based on data from a study consisting of 137 patients with advanced heart failure who received the device compared with outcomes from patients followed by a medical database who used other mechanically assisted circulatory support systems. According to the FDA, this was the first time the agency approved a heart pump using information from a database as a comparison.
Currently, there is an estimated 50,000 people worldwide who are candidates for heart transplants, but only roughly 5,000 receive one each year.
Source: HeartWare International, Inc.
Last Updated: 11/21/12; 10:15AM EST