Johnson & Johnson MedTech’s Dual Energy THERMOCOOL SMARTTOUCH SF Catheter has gained the European CE mark approval for treating cardiac arrhythmias.

This approval is backed by the SmartfIRE study, which evaluated the catheter in treating paroxysmal atrial fibrillation (PAF).

Powered by the TRUPULSE Generator, the irrigated, contact-force sensing catheter integrates with the CARTO 3 System for electro-anatomical mapping and tag indexing.

The company anticipates TRUPULSE Generator hardware compatibility by the first half of this year.

Designed on the same platform as the radiofrequency THERMOCOOL SMARTTOUCH SF Catheter, the Dual Energy version's safety and efficacy were investigated in the SmartfIRE trial.

When fully approved, the platform claims to enable electrophysiologists to switch between radiofrequency and pulsed-field energy within a single integrated device. The catheter is not currently approved in the US.

Johnson & Johnson MedTech electrophysiology president Jasmina Brooks said: “The Dual Energy THERMOCOOL SMARTTOUCH SF Catheter offers the benefit of both energy modes in one familiar device.

“We are pleased to bring forward this innovation to enable electrophysiologists to deliver safe and effective procedures for patients in Europe impacted by AFib [atrial fibrillation].”

The company noted that it is working to introduce the catheter to additional worldwide markets. In the US, enrolment for the SmartPulse trial was completed that involved 250 subjects with PAF across 27 sites, to assess the safety and effectiveness of the catheter.

The PulseSmart trial, which includes 136 subjects with drug-refractory PAF across seven sites in Australia and Canada, has also completed enrolment.

Catheter ablation is stated to be a minimally invasive procedure used by electrophysiologists. It disrupts irregular electrical pathways in the heart to treat cardiac rhythm disorders such as AFib.

Last November, the company announced an exclusive commercial distribution agreement in the US with Responsive Arthroscopy to expand sports soft tissue repair solutions.