Acutus Medical said today it launched a trial of its AcQMap high resolution imaging and mapping system designed to guide ablation procedures for treating persistent atrial fibrillation.
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 Carlsbad, Calif.-based company said the 1st patient has been treated in its Uncover-AF clinical trial, which is currently enrolling patients at centers across Europe and Canada.
“The AcQMap System ushers in a new standard of care allowing EPs who until now, have never been able to fully visualize all the electrical mechanisms combined with the functional mechanism of AF. Being able to truly see each heart beat in real-time, with CT quality imaging and full-chamber electrical-conduction maps has the potential to more accurately inform treatment decisions and improve patient outcomes,” Dr. Andrew Grace, who performed the 1st procedure in the trial, said in prepared remarks.
Early clinical results from trials of the AcQMap System showed more accurate left atrial reconstruction compared with CT/MRI and dipole density mapping led procedures.
“The initiation of this study marks another major milestone for the company and furthers our mission to improve the lives of patients living with persistent AF. We believe the clinical outcomes from UNCOVER-AF will confirm what we set out to achieve with this system—to allow EPs to obtain real-time images of the heart chamber and identify the true source of the arrhythmia, thus leading to improved patient outcomes and improved quality of life,” Acutus prez & CEO Randy Werneth said in a press release.
In May, Acutus Medical said it won CE Mark approval in the European Union for its AcQMap system designed for use with its AcQMap catheter.
In March, the company 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.
