This is a brief overview of information related to FDA’s approval of a new indication for an existing device. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its complete indications for use, and the basis for FDA’s decision
Product Name: Guidant Ventak Implantable Cardioverter Defibrillators (ICDs)
Manufacturer: Guidant Corporation
Address: 4100 Hamline Avenue North, St. Paul, MN 55112
Approval Date: July 18, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P910077S037a.pdf
What is it? Guidant Ventak Implantable Cardioverter Defibrillators (ICDs) are implanted devices that detect life-threatening heart rhythms (ventricular arrhythmias) and shock the heart back to a normal rate. Each device consists of a pulse generator (a battery and electronic circuitry) connected to one or two insulated wires (leads). The pulse generator is usually implanted under the collarbone, just beneath the skin. The main lead is inserted into the lower right heart chamber (the right ventricle). A second lead may be placed in the upper right heart chamber (the right atrium).
When is it used? Guidant Ventak ICDs are used to treat patients who have had, or who are at risk of developing, life-threatening ventricular arrhythmias. These patients have an increased chance of sudden cardiac death (when the heart stops pumping blood to the body).
What is the new use? Guidant Ventak ICDs are now also approved as a preventative treatment for patients who have had a prior heart attack and whose heart can no longer pump blood normally with each heartbeat. These patients can sometimes develop ventricular arrhythmias.
How does it work? The ICD continuously monitors the patient’s heartbeat through the implanted leads. When it detects a dangerous, abnormal heart rhythm, it shocks the heart back to a normal rhythm.
What will it accomplish? This treatment reduces the risk of sudden cardiac death by detecting an abnormal heart rate and delivering life-saving shocks to return the heart to a normal rhythm.
When should it not be used? ICDs should not be used in patients whose abnormal heart rhythms are considered to be temporary or reversible. They should not be used in patients who have single lead (unipolar) pacemakers.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p910077S037