This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product name: ALERT® System
Manufacturer: EPMedSystems, Inc.
Address: 575 Route 73 N., West Berlin, NJ 08091
Approval Date: November 27, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p990069a.pdf
What is it? The ALERT® System is a new treatment for atrial fibrillation that uses a special catheter to shock the inside of the heart. In atrial fibrillation, the upper chambers of the heart (the atria) beat very quickly or irregularly. Low-energy shocks from the ALERT® System help return the heartbeat to a normal rhythm.
The system consists of two parts: (1) a catheter and (2) the ALERT® Companion. The catheter is a thin tube with 2 narrow bands of electrodes (used to deliver the shocks). The Companion is a computer-controlled heart monitor and defibrillator that provides the energy for the shock.
How does it work? A doctor makes a small incision in the arm, neck, or groin and threads the catheter through blood vessels to the heart. Once in position, the catheter is attached to the Companion. The Companion monitors the heart’s internal electrical signals and delivers low-energy shocks to the heart wall. The ALERT® System can also pace the heart temporarily to help restore a normal heartbeat. After the procedure, the doctor removes the catheter.
When is it used? The ALERT® System is an alternative to external defibrillation (cardioversion) for patients with atrial fibrillation. Since the defibrillation shock is delivered inside the heart, rather than through the patient’s chest, it requires less energy. This treatment may be especially helpful for certain groups of patients, including those who are overweight.
What will it accomplish? The ALERT® System helps restore an irregular heartbeat to a normal rhythm. It is often combined with medication to help maintain normal (sinus) rhythm. If the heart can return to its normal rhythm, the symptoms associated with atrial fibrillation should improve.
When should it not be used? The ALERT® System should not be used in patients whose conditions make them unsuitable candidates for temporary pacemakers or internal atrial defibrillation.
Additional information: Summary of Safety and Effectiveness is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p990069