Acutus Medical this week announced it received regulatory approval in Japan for its AcQMap high resolution imaging and mapping system and the AcQMap 3D imaging and mapping catheter.
The approval represents a new era of non-contact arrhythmia management in Japan. Acutus Medical and its international alliance partner Biotronik have commenced training and early market development activities to prepare for additional innovations in 2023.
“We are excited to bring this innovative technology to Japan,” said Hans-Jürgen Wildau, segment head of EP and sensors for Biotronik. “These approvals represent another successful milestone in the market readiness work we’ve done with Acutus over the past 24 months. We believe Japanese physicians specifically will appreciate the innovation the Acutus platform brings to the diagnosis of complex arrhythmias, especially in mapping non-pulmonary vein triggers which is a significant unmet need in the treatment for atrial fibrillation.”
Carlsbad, California-based Acutus Medical designed the AcQMap 3D ultrasound-based imaging and non-contact mapping system to capture cardiac imaging information and cardiac activation mapping. The AcQMap system uniquely maps the electrical conduction of each heartbeat to characterize the most complex arrhythmia in the atrial chamber of the heart.
The ability to map every beat allows physicians to visualize global chamber activity of irregular heart rhythm conditions such as atrial fibrillation, complex flutters and tachycardias. The non-contact procedure helps personalize diagnosis and treatment for heart rhythm conditions.
“The AcQMap system and catheter clearance represents a major advancement in the tools available to EPs in Japan,” said David Roman, president & CEO of Acutus Medical. “This approval uniquely enables electrophysiologists in Japan to employ a fully non-contact system to aid in the personalized 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.”