Projects

THERMOCOOL SMARTTOUCH SF Ablation Catheter

The THERMOCOOL SMARTTOUCH® Surroundflow (SF) is a cardiac ablation catheter indicated for the treatment of atrial fibrillation (AF), including paroxysmal AF and persistent AF.

Project Type

Cardiac ablation catheter

Developer

Biosense Webster

Module

CARTO VISITAG™

Application

Atrial fibrillation

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The THERMOCOOL SMARTTOUCH® Surroundflow (SF) is a cardiac ablation catheter indicated for the treatment of atrial fibrillation (AF), including paroxysmal AF and persistent AF.

Developed by Biosense Webster, a subsidiary of Johnson & Johnson, the catheter is the only approved device, which combines contact force sensing with advanced irrigated porous tip ablation for improved efficiency.

The US Food and Drug Administration (FDA) approved the THERMOCOOL SMARTTOUCH SF ablation catheter for paroxysmal AF in August 2016.

Marketed as both unidirectional and bidirectional device in the US and Europe, the catheter received FDA approval for persistent AF in October 2020 based on the results of a prospective PRECEPT study.

Details of THERMOCOOL SMARTTOUCH SF ablation catheter

THERMOCOOL SMARTTOUCH SF ablation catheter features surround flow catheter porous tip and electrodes that deliver thermal energy to the specific region of the heart to treat AF by creating lesions.

The catheter’s stable contact force transmits exact location reference signal through location sensor and transmitter coil, promoting persistent lesion formation and reducing ablation time. It is integrated with the CARTO® 3 system to combine the contact force technology with 3D mapping, and improved navigation tools to measure stable contact force and position of the catheter tip.

The catheter provides uniform cooling at half the flow rate of previous generation irrigated catheters, facilitating the process of fluid management.

Benefits of THERMOCOOL SMARTTOUCH SF

THERMOCOOL SMARTTOUCH SF ablation catheter improves outcomes with a more stable catheter-tissue contact force.

The catheter reduces the procedure time by 19% and fluoroscopy time by 55%. It also improves the manoeuvrability and handling for exceptional control.

The catheter with the CARTO 3 system can facilitate personalised ablation approach for patients, resulting in high effectiveness for long-term in persistent AF patients.

CARTO 3 system

CARTO® 3 system is an innovative imaging technique that uses electromagnetic technology for 3D real-time mapping of the patient’s cardiac anatomy.

The system assists electrophysiologists by creating a precise 3D map and locating the exact position and direction of catheters in the heart during diagnostic and therapeutic procedures.

“The catheter received FDA approval for persistent AF in October 2020 based on the results of a prospective PRECEPT study”

3D image generated by the device helps doctors to direct the catheter to the site in the heart where RF energy administration is required.

CARTO 3 system employs fast anatomical mapping (FAM) technology that enables clinicians to easily construct a CT-like resolution map of the heart, reducing the need for fluoroscopy radiation during catheter ablation procedures.

It can run software modules that incorporate more innovative features and current innovations of the electrophysiology field.

PRECEPT study

PRECEPT trial is a prospective, non-randomised, multi-centre study on 381 patients with symptomatic persistent AF to assess the safety and efficacy of the THERMOCOOL SMARTTOUCH SF ablation catheter.

The trial took place at 27 sites across the US and Canada. The catheter with CARTO VISITAG® Module was utilised to conduct specific ablation strategies tailored to the individual patient.

All patients underwent pulmonary vein isolation of all veins, while 44.5% of them received additional left atrium ablation.

Approximately 80.4% patients treated with the THERMOCOOL ablation catheter with the CARTO VISITAG™ Module experienced freedom from symptomatic persistent AF at 15 months after treatment, while 86% of the patients experienced freedom from repeat procedures at 15 months.

In persistent AF patients, radiofrequency ablation with the catheter led to a clinically significant improvement in the quality of life (QOL), as well as a decrease in the use of antiarrhythmic drugs (AAD), cardioversion, and hospitalisation.

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