News | EP Mapping and Imaging Systems | October 27, 2016

Acutus Medical Announces First Patient Procedure in UNCOVER-AF Atrial Fibrillation Trial

European and Canadian clinical study evaluates AcQMap high-resolution imaging and mapping system

Acutus Medical, AcQMap High Resolution Imaging and Mapping System, atrial fibrillation, UNCOVER-AF trial, first procedure

October 27, 2016 — Acutus Medical announced the completion of the first patient procedure in the “Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation” (UNCOVER-AF) clinical study. The study will evaluate the incidence of device and procedure-related safety, effectiveness and efficiency using the AcQMap High Resolution Imaging and Mapping System to guide ablation in persistent atrial fibrillation (AF) patients.

Acutus Medical received CE Mark approval for the AcQMap System and AcQMap Catheter in May 2016. Patients are currently being enrolled in the UNCOVER-AF clinical study at electrophysiology (EP) centers of excellence throughout Europe and Canada. The first procedure was successfully completed by Andrew Grace, M.D., Ph.D. and Sharad Agarwal, M.D., at Papworth Hospital in Cambridge, United Kingdom.

“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,” said Grace. “Being able to truly see each heart beat in real-time, with CT [computed tomography]-quality imaging and full-chamber electrical-conduction maps has the potential to more accurately inform treatment decisions and improve patient outcomes.”

Persistent AF is a complex, heterogeneous, patient-specific arrhythmia with limited treatment options that consist of oral medications, electric shocks to convert the heart rhythm and empiric ablation strategies. Outcomes, regardless of treatment options, have been disappointing. The AcQMap System combines a real-time CT quality anatomy with an ability to map the electrical conduction of each heartbeat to precisely visualize electric sources across the entire chamber thus enabling the pinpointing of sites crucial for driving and maintaining AF. Following guided treatment, the next heartbeat can be remapped in seconds to confirm successful ablation and define additional treatment, if needed. This progressive treatment strategy of mapping, ablating and remapping to systematically break down the complexity of the AF frequently leads to spontaneous termination with conversion to sinus rhythm.

Early clinical results using the AcQMap System have demonstrated accurate left atrial reconstruction when compared with CT/magnetic resonance imaging (MRI) and dipole density mapping offering a significantly higher resolution than voltage-based mapping.

The AcQMap High Resolution Imaging and Mapping System is not available for sale in the United States.

For more information: www.acutusmedical.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD
Technology | Implantable Cardioverter Defibrillator (ICD)| September 22, 2017
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Overlay Init