NICE has developed a medtech innovation briefing (MIB) on the ThermoCool SmartTouch catheter for percutaneous radiofrequency ablation in atrial fibrillation.
ThermoCool SmartTouch is a single-use cardiac ablation catheter with a deflectable distal section and a contact force sensor at the tip. It is used to treat cardiac arrhythmias, such as atrial fibrillation, by mapping the electrical activity of the heart, delivering radiofrequency energy during ablation procedures, and confirming electrical isolation. ThermoCool SmartTouch differs from standard ablation catheters by providing a real-time measurement of the contact force applied by the catheter tip to the heart wall during the ablation procedure. This briefing includes 10 studies of mixed quality, including 2 randomised controlled trials and 2 large comparative studies. The studies reported a higher mean contact force, fewer pulmonary reconnections and shorter procedural, ablation and fluoroscopy times with ThermoCool SmartTouch compared with radiofrequency ablation with contact force measurements blinded or with conventional catheters. The list prices for the ThermoCool SmartTouch uni- and bi-directional catheters are £1,675 and £1,750 (excluding VAT) respectively, but additional components are needed for the ablation procedure.
MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.