FDA Approves Breakthrough Heart Failure Therapy

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{!caat UealrTes FDA Approves Breakthrough Heart Failure Therapy (NAPSA)—Nearly 5 million Americansare afflicted with heart failure, a chronic and disabling condition that robs patients of their ability to live independent, normal lives. The recent U.S. Food and Drug Administration approval of the Medtronic InSync cardiac resynchronization therapy represents the first major breakthrough in 30 years for the treatment of the condition. This implantable cardiac device brings new hope to thousandsof long-suffering patients who have moderate to severe heart failure. In healthy people, the two lower chambers of the heart contract together to pump blood through the body. But, for approximately half of all patients with heart failure, these chambers no longer contract at the same time. As a result, the heart is unable to pumpefficiently. InSync therapy normalizes the heart’s contractions and ensures that a patient’s heart pumps correctly and more efficiently by sending tiny electrical impulses to the heart muscle. Heart failure typically causes fatigue, shortness of breath, swelling of feet and ankles (edema) and other complications. Symptoms like these sent Florida resident Bob Binning, 60, to his doctor. After careful examination, Binning was diagnosed with severe heart failure. He and his wife began searching for treatments and solutions. Binning wasthe third person in the United States to receive InSync therapy as part of the MIRACLE new hope to hundreds of thou- things I thought I would never be part of again.” The InSyne device, slightly larger than two stacked silver dollars, is surgically implanted under the skin in the chest area by a specially trained electrophysiologist or cardiovascular surgeon. Three very thin insulated wires (leads) are threaded from the device through the veins and to the patient’s heart. The procedure is typically done with local anesthesia, so the patient remains conscious. Patients usually stay in the hospital overnight, and like Binning, are able to return to a more active lifestyle following their recovery. “Since I’ve had the InSynec implanted, I’ve been able to work part-time. I feel like I’m back in the world, participating in day-to-day activities.” Heart failure patients have traditionally been treated with an average of six medications for their condition, and 15 percent of hospital admissions for heart failure are related to medication noncompliance. Total treatment cost for U.S. patients with heartfailure is more than $38 billion annually, the most costly cardiovascular disease in the United States. InSyne therapy is not for everyone, but it may be effective and beyond anything I expected,” Binning said. “InSync therapy has given me a whole new chanceto live my life and to do so many with this debilitating and often deadly condition. “Heart failure took a terrible toll on the quality of my life,” Binning said. “Having InSync has given me back a future.” Signs and Symptoms of Heart Failure Heart failure patients, family members or others who would like more information about InSync therapy should visit www.medtronic.com. Signs and symptomsof heart failure include Fatigue Shortness of breath Swelling, usually of the feet and ankles If you think you are at risk for heart failure, see a heart specialist for evaluation and freatmentoptions. (Multi-center InSyne Randomized Clinical Evaluation) study, which tested the safety and effectiveness of the device. He noticed an immediate improvement. “Since the InSync has been implanted, my energy levels have increased above This cardiac device may give sands of patients with moderate to severe heartfailure. for at least 650,000 Americans