Acutus Receives Approval for AcQMap System & AcQMap 3D Imaging & Mapping Catheter in Japan

Acutus Medical Inc., an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, has achieved approval of its AcQMap High Resolution Imaging and Mapping System and the AcQMap 3D Imaging and Mapping Catheter in Japan.
 
Japan is the 2nd largest medical device market in the world and the EP Mapping and Ablation market is estimated to exceed $1.4 billion in 2022 with more than 150,000 procedures performed and grow to an estimated $1.8 billion by 2025¹.
 
Acutus’ International Alliance partner BIOTRONIK has commenced training and early market development activities in collaboration with Acutus Medical in preparation for more significant activities in 2023.
 
“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.”
 
“We are excited to bring this innovative technology to Japan,” said Dr. Hans-Jürgen Wildau, segment head EP & Sensors, BIOTRONIK SE & Co. KG. “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.”
 
The AcQMap 3D Imaging and Mapping Catheter are the cornerstones of Acutus’ innovative mapping platform as the world’s only integrated ultrasound-based imaging and non-contact mapping catheter capable of capturing cardiac imaging information and cardiac activation mapping, all without touching the heart. The AcQMap System can uniquely map the electrical conduction of each heartbeat to characterize the most complex arrhythmias across the entire atrial chamber.
 
The ability to map every beat allows the physician to visualize global chamber activity of irregular rhythms like atrial fibrillation, complex flutters and tachycardias, and clinically relevant, fleeting rhythms such as non-sustained tachycardia which are all burdensome with conventional contact-based systems that rely on probing the heart sequentially over many heartbeats to create diagnostic maps. The unique capability of AcQMap to understand these complex arrythmias helps physicians to personalize a diagnosis and treatment strategy for each individual patient leading to superior outcomes.^2,3,4
 
References:
¹ Millennium Research Group: 2021 Electrophysiology Mapping and Ablation Devices | Market Insights | Japan | 2021
² Shi R, et al, An Individualised Ablation Strategy to Treat Persistent Atrial Fibrillation: Core-to-Boundary Approach Guided by Charge-Density Mapping, Heart Rhythm 2021
³ Shi R, et al. Novel aggregated multiposition noncontact mapping of atrial tachycardia in humans: From computational modeling to clinical validation. Heart Rhythm. 2022
⁴ Gagyi R, et al. New Possibilities in the Treatment of Brief Episodes of Highly Symptomatic Atrial Tachycardia: The Usefulness of Single-Position Single-Beat Charge Density Mapping. Circulation: Arrhythmia and Electrophysiology 2021