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: NaviStar DS and Celsius DS Diagnostic/Ablation Catheters, Stockert 70 RF Generator and accessories
Manufacturer: Biosense Webster Inc.
Address: 3333 Diamond Canyon Road, Diamond Bar, CA 91765
Approval Date: September 27, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010068a.pdf
What is it? A catheter is a flexible plastic tube about the thickness of a piece of spaghetti, that is placed into a body cavity. An “ablation catheter” for the heart has no inner hollow space. Instead, it has wires running on the inside. The wires are connected to an electrical system that allows a physician to view the heart’s action on a viewing screen. The heart ablation catheter is also connected to a generator that delivers radiofrequency (RF) energy to the tip of the catheter in the heart. The RF energy generates heat, which is used to destroy abnormal heart tissue responsible for causing an abnormal heart beat (tachycardia).
How does it work? The catheter is put into the femoral vein -- a vein near the groin at the top of the leg. The catheter is then threaded through the vein into the chambers of the heart. The catheter end outside the body is connected to the electrical system that allows the physician to view the beating heart on a screen. By watching the screen, the doctor can place the catheter in exactly the correct spot to treat the abnormal heart beats. Once the catheter is in place, the doctor turns on the energy from the generator to heat the tip of the catheter. This heat destroys a small part of the heart that causes the abnormal heart beat. This destruction of heart tissue is called ablation.
When is it used? The ablation catheter system is used in patients who have atrial flutter -- a specific kind of fast heart beat (tachycardia).
What will it accomplish? The destruction of a small amount of heart tissue (ablation) will block the abnormal electrical pathways in the heart that cause the atrial flutter. The procedure has been shown to cure atrial flutter in approximately 90% of patients.
When should it not be used? The catheter should not be used in patients who have:
- an infection in the blood
- a tumor or blood clot in the left side of the heart
- an artificial tricuspid valve
Additional information - Summary of Safety and Effectiveness and Labeling is available at:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P010068