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: St. Jude Medical® Epic™ HF Defibrillator Model V-338, St. Jude Medical® Atlas® + HF
Defibrillator Model V-340; Aescula™ Left Heart Lead Model 1055K; QuickSite™ Left Heart Lead Model
1056K; Model 3307 Version 4.5m Programmer Software
Manufacturer: St. Jude Medical, Inc.
Address: 701 E. Evelyn Ave., Sunnyvale, CA 94086
Approval Date: June 30, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030054a.pdf
What is it? The Epic HF and Atlas + HF ICD Systems are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT) if you are a patient with advanced heart failure.
The systems consist of two parts:
- a pulse generator containing a battery and electronic circuitry, and
- three insulated lead wires that connect to the pulse generator.
How does it work? The pulse generator is usually implanted below the collarbone, just beneath the skin. One lead is placed in an upper heart chamber (the right atrium) and the two other leads are placed in each of the lower heart chambers (the ventricles). When the device is functioning as an ICD, it senses dangerous abnormal heart rhythms and shocks the heart back into a normal rhythm. The CRT portion of the device coordinates the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body.
When is it used? The Epic™ HF and Atlas® + HF Systems should be used only if you are at risk for life-threatening heart rhythm problems and also have symptoms of advanced heart failure despite taking heart failure medication. Symptoms of heart failure such as fatigue, shortness of breath and difficulty performing daily activities, are caused by the heart not pumping enough blood to meet the body's needs. If your lower heart chambers do not contract together, CRT helps coordinate the beating of the heart.
What will it accomplish? The Epic™ HF and Atlas® + HF Systems will deliver a life-saving shock to return the heart to a normal heart rhythm and prevent sudden cardiac death. The systems may also relieve some of the symptoms associated with heart failure, including shortness of breath and fatigue during exercise, which may result in a better quality of life.
When should it not be used? The Epic™ HF and Atlas® + HF Systems should not be used if your heart failure or life-threatening heart rhythm abnormality are reversible or temporary. The systems also should not be used if you are not on the appropriate drugs for heart failure.
- Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030054