Biosense Webster , a subsidiary of Johnson & Johnson Medical Devices Companies, has secured the US Food and Drug Administration (FDA) approval for its HERMOCOOL SMARTTOUCH SF Ablation Catheter for the treatment of persistent atrial fibrillation (AF).
AF is considered to be one of the important public health issues that affects the health of millions of people and increases the critical burden on healthcare systems.
Persistent AF is said to be a continuous AF that lasts for over seven days and up to one year. The management of persistent AF intends to stop AF recurrence and associated disabilities while minimising the side effects of treatment.
The approval for HERMOCOOL SMARTTOUCH SF Ablation Catheter is based on the data from the PRECEPT trial, which examined the safety and efficacy of the catheter in persistent AF patients.
It is the first prospective, multi-centre investigational device exemption study to assess a radiofrequency (RF) catheter ablation in patients with persistent AF.
It was found in the study that 80% of persistent AF patients experienced clinical success at 15 months after ablation therapy, using the THERMOCOOL SMARTTOUCH SF catheter with the CARTO VISITAG Module.
Biosense Webster worldwide president Uri Yaron said: “This approval and data from the PRECEPT study help to further our commitment to advancing AF treatment, providing electrophysiologists with state-of-the-art options for their patients.”
According to the company, Radiofrequency ablation with the THERMOCOOL SMARTTOUCH SF Catheter resulted in ‘clinically meaningful’ improvement in the quality of life (QOL) and decrease in antiarrhythmic drug (AAD) use, cardioversion and hospitalisation in persistent AF patients.
Last year, Biosense Webster started enrolling and treating patients in a US Investigational Device Exemption study of its QDOT MICRO Radiofrequency (RF) Ablation Catheter.
In 2018, the company successfully treated AF in the first patient who participated in a study of its new QDOT MICRO catheter.