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U.S. Department of Health and Human Services

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NAVISTAR® THERMOCOOL® and EZ Steer THERMOCOOL® Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation - P030031S011

photo of NAVISTAR® THERMOCOOL® and EZ Steer THERMOCOOL® Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation - P030031S011This 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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.


Product Name: NAVISTAR® THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter
PMA Applicant: Biosense Webster, Inc.
Address: 3333 Diamond Canyon Road, Diamond Bar, CA 91765
Approval Date: February 6, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030031S011a.pdf

What is it? The NAVISTAR® THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter is used to destroy (ablate) abnormal heart tissue that causes an intermittent abnormal heartbeat in the upper chambers of the heart (paroxysmal atrial fibrillation).

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® 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 paroxysmal atrial fibrillation. 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 ablated.

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 catheter in exactly the correct spot to treat the abnormal heartbeats. Once the 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 heartbeat.

When is it used? The irrigated ablation catheter system is used in patients who continue to experience symptoms of paroxysmal atrial fibrillation despite treatment with drugs intended to normalize the heart beat. While atrial fibrillation is a major risk factor related to stroke, no conclusive evidence exists relating treatment of symptoms by ablation to a reduction in stroke. Therefore, the FDA agrees with doctor’s associations recommendations to continue blood thinning medications for patients at risk for stroke after ablation procedures for paroxysmal atrial fibrillation.

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 fibrillation. The procedure has been shown to be effective in treating symptoms related to atrial fibrillation for up to one year in approximately 60% of patients.

Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.