Medtronic announces FDA approval of new therapy option for patients with atrial fibrillation
New AF Device-Based Treatment Reduces Severe Symptoms, Enabling Better Patient Quality of Life
Providing new hope for a select group of often-hospitalized patients, Medtronic, Inc. recently announced U.S. Food and Drug Administration approval of a revolutionary device-based therapy that improves quality of life and reduces the debilitating symptoms of atrial fibrillation.
The treatment is delivered by a system that includes the Medtronic GEM III AT implantable cardioverter defibrillator (ICD) and the InCheck AT Patient Assistant. The InCheck AT Patient Assistant is a small handheld device that tells patients when their heart is experiencing atrial fibrillation. Patient's can then use the device to initiate their own atrial therapy, outside of the physician's office or clinic.
The GEM III AT ICD is Medtronic's exclusive second-generation implanted device to be FDA-approved for a new group of patients whose primary indication is symptomatic fast heart rates in the upper chambers of the heart (atrial fibrillation) and for whom antiarrhythmic drugs have been ineffective. When used with the InCheck AT Patient Assistant device, the system helps patients restore sinus rhythm at the touch of a button, allowing them to resume the activities of daily life. The GEM III AT ICD includes Medtronic's proprietary AT(TM) Trio, a suite of arrhythmia management tools that help physicians know the patient's condition, protect the patient from the effects of atrial arrhythmias, and deliver therapies to restore the patient's normal heart rhythm.
Atrial fibrillation is the world's most common sustained heart rhythm problem. Medtronic officials estimate that up to 5 percent of the 3.3 million patients in the U.S. with atrial fibrillation could potentially benefit from this new therapy. These patients typically suffer from prolonged periods of atrial fibrillation (24 hours or longer) and frequently must be hospitalized for electrical or chemical cardioversion therapy when medications have been ineffective. Severe AF symptoms include fatigue, shortness of breath, chest pains, heart palpitations and difficulty breathing, which may prevent patients from participating in activities such as shopping, climbing stairs, lifting and cooking.
"For certain AF patients, this is the right therapy," said Dr. Michael Gold, Chief of the Electrophysiology Laboratory at the University of Maryland. "There are a number of patients whose lives are severely affected by atrial arrhythmias who have not received adequate help from medications in reducing their symptoms. My patients who've needed external cardioversion therapy to end atrial arrhythmia episodes have found that this therapy results in fewer hospitalizations. They feel better after using the implanted therapy and appreciate the control the patient-activated device gives them in managing their heart rhythm."
Dr. Gold added, "Patients with severe, debilitating atrial fibrillation who have not received adequate help should see a heart rhythm specialist to determine if they are candidates for this new therapy option."
Jack Wills from Pennsylvania is one of the many patients with severe atrial fibrillation who believes this new device therapy has improved his life dramatically. "Before having the device implanted, I felt so weak and helpless. I wasn't even able to walk very well. If I had to walk up stairs, it was a huge hardship on my body. Now, with the device, I feel great. The difference in my life is unbelievable."
Another patient, Bill Luithle from New Jersey, commented, "Before I had the device I would program my life around AF. I never knew when it would make me feel badly and not be able to do normal activities. Now my life is almost continual, as opposed to a life of interruptions."
Stephen Mahle, president, Medtronic Cardiac Rhythm Management, noted that the GEM III AT ICD had received FDA approval in February for patients whose primary symptoms are too-rapid ventricular rates but who have or could develop atrial rhythm problems. "Today's FDA approval for this new indication means that a whole new group of patients who are symptomatic from their atrial fibrillation and for whom antiarrhythmic drugs have been ineffective can now achieve an improved quality of life with the GEM III AT's comprehensive atrial management capabilities."
In addition to the GEM III AT ICD, Medtronic offers physicians and their patients the greatest variety of therapy options for managing atrial fibrillation, including innovative ablation technologies, surgical tools and implanted devices.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.
Source: Medtronic, Inc.
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