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: Response™ CV Catheter System
Manufacturer: St. Jude Medical, Daig Division, Inc.
Address: 14901 DeVeau Place, Minnetonka, MN 55345
Approval Date: May 7, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p020052a.pdf
What is it? The Response™ Catheter is a cardiac catheter that is used to evaluate cardiac conditions and electrically restore the heart’s normal rhythm when the upper chambers of the heart (the atrium) are beating in a fast and/or non-normal rhythm.
How does it work? The Response™ Catheter is placed inside a small vein within the heart called the coronary sinus. The catheter has two functions: it can detect the electrical activity of the heart and apply electrical energy like an implantable pacemaker and it can also electrically restore the top chamber of the heart to a normal rhythm if necessary. In use, the catheter helps the health care practitioner to evaluate the heart’s electrical activity. If necessary, it can administer a small electrical shock, causing the top portion of the heart to contract.
For a drawing of the heart please go to: http://www.nlm.nih.gov/medlineplus/ency/imagepages/1056.htm
When is it used? The Response™ CV electrophysiology catheter is used to detect abnormal cardiac electrical activity and is used for the restoration of the heart to normal rhythms from within the heart when fast, abnormal rhythms are present in the upper chambers of the heart.
What will it accomplish? The Response™ CV system successfully returned the heart to a normal rhythm in 96% of the patients in the clinical study. Side effects were similar to those seen during electrophysiology catheterization procedures, such as nausea, vomiting, low blood pressure, fluid retention in the lungs, and rapid contractions of the lower chambers of the heart.
When should it not be used? The Response™ CV system should not be used
- when the patient’s abnormal heart rhythms are caused by chemical imbalances,
- when unstable cardiac conditions are present,
- directly in the left side of the heart,
- in patients that cannot tolerate blood thinning therapies,
- for cardioversion or defibrillation of abnormal rhythms in the ventricles (lower chambers) of the heart.
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=p020052