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 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:

• THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter
• THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter
• SMARTABLATE Generator or Stockert 70 Generator
• SMARTABLATE Pump, nGEN™ Pump, or COOLFLOW® Pump
• SMARTABLATE Tubing or COOLFLOW Tubing

PMA Applicant: Biosense Webster, Inc.
Address: 33 Technology Drive Suite 200, Irvine CA 92618
Approval Date: September 30, 2020
Approval Letter: Approval Order

What is it?

The THERMOCOOL SMARTTOUCH ablation catheter is a long, flexible wire with a metal electrode at its tip that can be heated and used to treat atrial fibrillation, an abnormal heart rhythm causing fast and irregular heartbeats.

This approval expands the indications for use to treat patients with atrial fibrillation episodes that last for more than seven days but less than 12 months (persistent atrial fibrillation duration less than 12 months) that have not been corrected by medicine.

How does it work?

A doctor inserts the catheter through a vein in the upper leg (groin). The catheter tip is positioned at the opening of a vein that carries blood from the lungs to the heart, called a pulmonary vein. The doctor then turns on the catheter tip, heating up, or ablating, the heart tissue in order to block abnormal electrical signals from the pulmonary vein to the heart, which is what causes the abnormal heart rhythm. The catheter is then moved to the next pulmonary vein. The process is repeated until all pulmonary veins are treated.

When is it used?

A doctor uses the catheter together with other parts of the same system to treat paroxysmal, or intermittent, atrial fibrillation as well as persistent atrial fibrillation, when these conditions do not get better with medicine.

What will it accomplish?

In a clinical study, doctors used this catheter to treat 333 patients with persistent atrial fibrillation of less than 12 months and atrial fibrillation-related symptoms for whom medicine failed to correct the heart rhythm. The patients were followed for 15 months after the first treatment and the abnormal heart rhythm did not return in 59.3% of patients. The treatment was also associated with reported improvements to quality of life.

When should it not be used?

The device should not be used in patients who:

• Had valve surgery or heart surgery in the last eight weeks
• Have tumors or clots inside their hearts
• Have artificial heart valves
• Have infections in their bloodstreams (active systemic infections)

The device should be used in limited ways for patients who:

• Have some types of heart patches (repairs)
• Had their aortic valve repaired

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness
• Physician Labeling
• Physician Labeling Part 2
• PMA Database Entry