Acutus Medical has secured approval for its AcQMap High Resolution Imaging and Mapping System and the AcQMap 3D Imaging and Mapping Catheter in Japan.
The AcQMap System can define the most complicated arrhythmias throughout the entire atrial chamber by mapping the electrical conduction of each pulse in a unique way.
The US-based firm said that the AcQMap 3D Imaging and Mapping Catheter are the world’s first integrated ultrasound-based imaging and non-contact mapping catheter.
A part of Acutus’ mapping platform, both the products can collect cardiac imaging data and cardiac activation mapping without contacting the heart.
The ability to map every heartbeat enables the doctor to see the activity of the heart chambers during irregular rhythms, complex flutters and tachycardias, and clinically significant, transient.
Earlier it was difficult to see with traditional contact-based systems that depend on probing the heart sequentially over many heartbeats to create diagnostic maps.
AcQMap’s ability to comprehend these intricate arrhythmias enables doctors to customise a diagnosis and treatment plan for every patient, producing better results.
Acutus Medical president and CEO David Roman said: “The AcQMap System and Catheter clearance represents a major advancement in the tools available to EPs in Japan.
“This approval uniquely enables electrophysiologists in Japan to employ a fully non-contact system to aid in the personalised diagnosis and treatment of patients suffering from cardiac arrhythmias.
“We view Japan as one of several key growth drivers to accelerate long-term performance. We look forward to entering Japan with BIOTRONIK given its established and respected position in the market.”
Acutus Medical and its International Alliance partner BIOTRONIK started training and early market development initiatives for their combined activities in 2023.
Last month, the company secured FDA approval to include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Watchman LAAC Device.
