CARLSBAD, CA—May 4, 2016—Acutus Medical, an electrophysiology company committed to transforming how electrophysiologists (EPs) image, diagnose and treat complex arrhythmias, today announced CE Mark approval for its AcQMap™ High Resolution Imaging and Mapping System and AcQMap™ Catheter, enabling the company to initiate commercial activities.
"The CE Mark approval of our AcQMap System marks a significant milestone for the company and for the EP community. AcQMap will provide for the first time, the ability to unlock the mysteries of cardiac activation by truly mapping complex arrhythmias in real-time, enabling clear identification of mechanisms, and providing an accurate guide for ablation therapy," said Randy Werneth, President and Chief Executive Officer of Acutus. "This approval comes on the heels of our $75 million Series C financing, which will be instrumental in building out our commercial operations in the European community and beyond."
About AcQMap High Resolution Imaging and Mapping System
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The AcQMap High Resolution Imaging and Mapping System is the first and only system to detect and display both standard voltage-based and higher resolution charge-source (dipole density) maps. The system is also able to generate real-time, 3D images of the heart chamber using ultrasound with quality comparable to a CT or MRI in a matter of minutes. Dipole, non-contact mapping creates a highly accurate, instantaneous global view that captures the activation pattern of every heartbeat making it uniquely capable of mapping and displaying both stable and unstable cardiac arrhythmias.
"During a recent AcQMap procedure, we were able to systematically map atrial fibrillation (AF) and eliminate the identified sites of interest, ultimately restoring the patient to their native rhythm," said Andrew Grace, M.D., Ph.D., from Cambridgeshire, UK-based Papworth Hospital. "The ability to map and quickly re-map after each set of ablations makes it possible to truly visualize AF and to achieve sinus rhythm."
The AcQMap High Resolution Imaging and Mapping System is not available for sale in the U.S.
Heart Rhythm Society Meeting
AcQMap will be the subject of two poster presentations at the Heart Rhythm Society Meeting in San Francisco, May 4-7. Presentations are both scheduled for May 5th as follows:
Date: Thursday, May 5, 2016 from 2:00 – 5:00 p.m.
Title: Noncontact Dipole Density Mapping of Complex Atypical Flutters Using an Ultrasound-Electrode Array Catheter: Comparison to Conventional Contact
