Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster subsidiary said it won pre-market approval from the FDA for its ThermoCool SmartTouch force-sensing ablation catheter, making it the 1st such device to hit the U.S. market.
The device uses radiofrequency energy to blast interior portions of the heart muscle to prevent an irregular heart rhythm called atrial fibrillation. The ThermoCool SmartTouch device differs from other ablation catheters in that it gives direct, real-time feedback about the degree of contact between the ablation electrode and the heart wall.
Biosense Webster cited data from the Smart-AF trial showing that "it is the consistent and stable application of contact force on the heart wall that positively impacts the efficacy of the procedure" in patients with drug-resistant symptomatic paroxysmal atrial fibrillation. One-year data from the study showed a 74% "overall success rate" with the ThermoCool SmartTouch device. That number rose to 88% when physicians stayed within a targeted range at least 85% of the time, according to a press release.
"The ThermoCool SmartTouch Catheter is an important new device that will benefit the electrophysiology community, as it will enable us to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation," principal investigator Dr. Andrea Natale of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Cente said in prepared remarks. "Data from the SMART-AF Trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes. The use of contact force-sensing technology has emerged as a critical tool in delivering optimal outcomes in the treatment of patients with atrial fibrillation and represents a major advancement for the clinical community."
"We are pleased to be able to introduce this important advancement to help clinicians enhance the quality of care they deliver for the thousands of U.S. atrial fibrillation patients in need of alternative treatments to drug therapy," added Biosense Webster president David Shepherd. "The burden of atrial fibrillation on quality of life, morbidity and mortality is well-documented and we are committed to developing life-enhancing therapies to continue addressing unmet needs in this space."
St. Jude Medical (NYSE:STJ) is chasing Biosense Webster in the force-sensing ablation game, hoping the TactiCath technology it acquired along with Endosense last August will win an FDA nod.
