Acutus Medical said today it won CE Mark approval in the European Union for its AcQMap high resolution imaging and mapping system designed for use with its AcQMap catheter.
The company’s AcQMap imaging and mapping system is designed to detect and display standard voltage-based and higher resolution charge-source maps, and is able to generate real-time, 3D images of the heart chamber using ultrasound.
“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. 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,” CEO Randy Werneth said in a press release.
Acutus Medical said the maps and 3D images of the heart chamber are on par with CT or MRI generated images in a period of minutes.
“During a recent AcQMap procedure, we were able to systematically map atrial fibrillation and eliminate the identified sites of interest, ultimately restoring the patient to their native rhythm. 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,” Dr. Andrew Grace of Cambridgeshire’s Papworth Hospital said in a prepared statement.
In March, Acutus Medical said it closed a Series C funding round worth $75 million for the AcQMap 3D cardiac mapping technology it’s developing – including a contribution from an unnamed strategic investor.
Carlsbad, Calif.-based Acutus said participants in the round included new backers Deerfield Management, Xeraya Capital and the undisclosed strategic; prior investor Advent Life Sciences also participated.