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™ and CELSIUS™ THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter
Applicant: Biosense Webster, Inc.
Address: 3333 Diamond Canyon Road, Diamond Bar, CA 91765
Approval Date: November 5, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030031a.pdf
What is it? The NAVISTAR™ and CELSIUS™ THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter is used to destroy (ablate) abnormal heart tissue that causes an abnormal heart beat (tachycardia). A catheter is a flexible plastic tube about the thickness of a piece of spaghetti, which is placed into a body cavity. An irrigated ablation catheter such as the NAVISTAR™ and CELSIUS™ THERMOCOOL® has wires running on the inside as well as a tube to deliver fluids. The wires are connected to an electrical system that allows a physician to view the heart’s action on a viewing screen. The 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 ablate abnormal heart tissue that causes tachycardia. The tube is used to deliver fluids to the ablation site in order to cool the tip of the catheter so that a larger amount of heart tissue can be destroyed.
How does it work? The ablation catheter is put into a vein near the groin at the top of the leg (femoral vein). The catheter is then threaded through the vein into the chambers of the heart. The ablation 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 ablation catheter in exactly the correct spot to treat the abnormal heart beats. Once the ablation catheter is in place, the doctor turns on the energy from the generator to heat the tip of the ablation catheter. This heat destroys a small part of the heart that causes the abnormal heart beat.
When is it used? The ablation catheter is used in patients who have atrial flutter -- a specific kind of fast heart beat (tachycardia).
What will it accomplish? The ablation of a small amount of heart tissue 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 85% of patients.
When should it not be used? The catheter should not be used:
- In patients who have a clot inside the heart
- In patients who have an infection in the blood
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=p030031