This is a brief overview of information related to the 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 the FDA's approval.
Product Name: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
PMA Applicant: Abbott Medical
Address: 5050 Nathan Lane North, Plymouth, MN 55442
Approval Date: November 23, 2021
Approval Letter: Not Yet Available
What is it? The TactiCath 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 groin (upper leg). The doctor positions the catheter tip 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 doctor moves the catheter to the next pulmonary vein. The process is repeated until all pulmonary veins are treated. The doctor also uses the catheter to heat or ablate other areas in the heart's upper chambers that cause atrial fibrillation.
When is it used? A doctor uses the TactiCath Contact Force Ablation Catheter together with other parts of the 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 the TactiCath Contact Force Ablation Catheter to treat 223 patients with persistent atrial fibrillation of less than 12 months duration and atrial fibrillation-related symptoms. The patients were followed for 15 months including a six-month period for medication adjustments and re-treatment. The abnormal heart rhythm did not return in 133 out of the 223 (60%) of the patients. The treatment was associated with reported improvements to quality of life.
When should it not be used? The device should not be used in patients who:
- Had a heart surgery where an incision was made into at least one of the four heart chambers within the preceding four weeks
- Have tumors or clots inside their heart
- Have artificial heart valves
- Have active systemic infections (bloodstream infections)
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness (Not Yet Available)
- Physician Labeling (Not Yet Available)
- PMA Database Entry (Not Yet Available)