Catheter ablation procedures to treat cardiac arrhythmias are delicate procedures requiring the surgeon to ablate just enough, but not too much of offending tissue. This is typically done by measuring the changing ECG and impedance, indicators that don’t provide a direct indication of how the catheter is affecting cardiac tissue.
Biosense Webster just received FDA approval to offer physicians in the U.S. the only ablation catheter that provides real-time contact force information where the tip meets cardiac tissue. The THERMOCOOL SMARTTOUCH catheter is paired with the company’s CARTO 3 System that delivers the energy to the device and provides a control interface.
More about the latest study of the device from the announcement:
Without this technology, catheter tip-to-tissue contact has to be estimated through other indirect measures such as electrogram parameters and impedance but they have been shown to be poor predictors of contact force.
The safety and effectiveness of the THERMOCOOL® SMARTTOUCH® Catheter were evaluated as part of a prospective, multicenter study called the SMART-AF Trial in patients with drug-resistant symptomatic paroxysmal atrial fibrillation. One-year results from the trial showed that patients experienced a 74 percent overall success rate after treatment with the THERMOCOOL® SMARTTOUCH® Catheter. Importantly, data from the trial showed higher success rates the longer physicians stayed within a targeted contact force range, with one-year results demonstrating an 88 percent success rate when physicians stayed within a targeted range greater than or equal to 85 percent of the time. The trial demonstrated for the first time that it is the consistent and stable application of contact force on the heart wall that positively impacts the efficacy of the procedure in this patient population.