An advisory panel to the US Food and Drug Administration (FDA) today took a first step to facilitate use by US cardiologists of emerging therapeutic options to help many Americans suffering from atrial fibrillation, the world's most common heart rhythm disorder.
The panel, made up of physicians, other scientists and consumer members, voted to recommend that the FDA approve expansion of indications for the use of the Medtronic Jewel® AF implantable cardioverter defibrillator, which was approved by the agency for US commercial release in June 2000. The system constantly monitors its wearer's heart rhythm and provides therapy to restore a normal pattern when needed. In addition to conventional automatic therapies, the Jewel AF offers a unique new patient-activated therapy option to interrupt troublesome arrhythmias. This option allows patients to control when and where they receive corrective therapy, increasing patient empowerment and convenience.
At present, the device is indicated only for patients with conditions that combine too-rapid atrial arrhythmias with similarly fast heart rhythms in the lower chambers of the heart (ventricles) or who have rapid-rhythm problems in the ventricle only. Approval by the FDA, which usually follows positive recommendations of its advisory panels, would allow US physicians to prescribe the Jewel AF device for a new group of patients who have significant symptoms from their AF disease and for whom antiarrhythmic drugs have been ineffective. The panel's action was accompanied by recommendations concerning medical management of these patients and for a study of patient outcomes to follow FDA approval of market release. On approval, it would be the only FDA-approved device for its designated patient population.
About 250,000 Americans are estimated to be in the latter group, many of whom now face regular, inconvenient, and costly hospital visits for electrical cardioversion therapy.
Meeting in Rockville, MD, the panel heard two physicians describe positive experience with device-based therapy in clinical evaluations involving patients with only an atrial fibrillation indication. Drs. Michael Gold, of the University of Maryland Hospital in Baltimore, and David Schwartzman, of the Atrial Arrhythmia Center at the University of Pittsburgh, also answered panelists' questions.
"A device-based strategy for atrial rhythm control using the Jewel AF device is a significant step," Dr. Schwartzman commented. "In my experience, this approach has reliably improved the quality of life of patients who were quite severely affected by atrial arrhythmias."
Data presented at the hearing indicated that patients in the clinical trial had a significant improvement in quality of life as measured by standard questionnaires, as well as reduced symptoms associated with arrhythmias in the heart's upper chambers.
Atrial fibrillation, which is associated with increased risk of death from stroke along with increased cost to healthcare systems, is estimated to affect 5.5 million persons worldwide. Prevalence of the disease increases with age, doubling in each decade of age after 50. In atrial fibrillation, the heart rhythm loses its coordination and the upper chamber races ineffectively at 300-600 beats per minute rather than the normal 60-100. Pumping power of the heart is cut by a third, as blood stagnates and can even clot, elevating the risk of stroke fivefold.
Stephen H. Mahle, president, Medtronic Cardiac Rhythm Management, commented, "The panel's endorsement is a significant milestone, but only the beginning. Medtronic is committed to providing effective atrial therapy solutions to reduce the frequency and severity of atrial arrhythmia symptoms for the thousands of patients who haven't received adequate help. We are confident that the FDA will recognize and share this objective."
The Medtronic Jewel AF device for atrial fibrillation only patients is approximately the size of a small pager and is typically implanted in the pectoral region of the chest. By using an accessory, the system's handheld activator, a patient can non-invasively administer the system's atrial therapy when needed.
The Medtronic Jewel AF is the first implantable device to offer therapeutic capabilities for detecting and treating arrhythmias of the atria (upper chambers), in addition to the ventricles (lower chambers). The device also offers new atrial pacing algorithms and a broad selection of both atrial pacing and cardioversion therapies.
Building on capabilities of the Jewel AF and offering new patient-friendly features is the Medtronic GEM III AT system, the world's most comprehensive ICD for managing tachyarrhythmias in the upper chamber of the heart as well as in the lower chambers. The new defibrillator, not yet approved for commercial marketing in the United States, offers the InCheckÔ AT Patient Assistant designed to provide ambulatory symptom marking and heart rhythm status to the patient as well as the hand-held activator that allows convenient, out-of-the-office treatment. The GEM III AT has elicited positive reports from physicians evaluating it in Europe.