Arrhythmia management company Acutus Medical has secured CE mark approval for its suite of next-generation EP products for commercialisation in Europe.

The approved EP products consist of AcQCross family of universal transseptal crossing devices, the next generation AcQGuide MAX and VUE large bore delivery sheaths and the next generation AcQMap mapping catheter.

Acutus’s new products have been developed to streamline procedural workflow in all left heart procedures and further enhance ease-of-use of the firm’s non-contact mapping to help electrophysiologists rapidly and precisely map the complex atrial arrhythmias within minutes.

Acutus Medical president and CEO Vince Burgess said: “Our R&D investments are translating into meaningful clinical innovations, as we build a comprehensive portfolio of therapy management solutions that make procedures safer, simpler and more effective.”

Transseptal crossing devices are suitable for use in a range of electrophysiology and structural heart procedures such as atrial fibrillation ablation, left atrial appendage occlusions, and transcatheter mitral valve repair.

The new AcQCross family of catheters comprise versions that are length, diameter and tip-matched and designed to lock into the hub of sheaths currently used in various left heart procedures.

AcQGuide MAX and VUE steerable sheaths will help enhance handling and deliverability, as well as facilitate quicker anatomy reconstruction and mapping acquisition times when used along with Acutus’ AcQMap 3D imaging and mapping system.

Expected to be available by the end of this year, the VUE sheath features tip electrodes that will facilitate catheter localisation and improved workflow in procedures intended to minimise the use of fluoroscopy.

The next-generation AcQMap 3D imaging and mapping catheter is the only integrated high-resolution ultrasound-based imaging and non-contact mapping catheter that can capture cardiac imaging information.

Its cardiac electrical activation mapping is enhanced with improved torque response, handling, and manoeuvrability.

The advanced transducer and electrode design of AcQMap catheter enable to combine with the AcQMap system to help electrophysiologists create an anatomical map of the atrial chambers of the heart.

In addition, it will help map simple and complex electrical patterns of the heart in sinus and complex arrhythmias.