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Acutus Medical receives FDA clearance for AcQGuide Steerable Sheath

Press releases may be edited for formatting or style | May 03, 2017
CARLSBAD, Calif.--(BUSINESS WIRE)--Acutus Medical®, a company committed to transforming the lives of millions of patients with complex arrhythmias, today announced the FDA clearance of the AcQGuide™ Steerable Sheath. The company will also feature several international presentations highlighting the AcQMap® High Resolution Imaging and Mapping System at the Heart Rhythm Society’s 38th Annual Scientific Sessions from May 10-12 in Chicago, IL.

The clearance of AcQGuide marks the first U.S. regulatory milestone for the company. The AcQGuide Steerable Sheath is a percutaneous catheter introducer designed to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chambers of the heart.

Acutus is currently pursuing FDA clearance for the AcQMap High Resolution Imaging and Mapping System, including the AcQMap 3D Imaging and Mapping Catheter. Both products received CE Mark in May of 2016.

Heart Rhythm Society Meeting Participation

Dr. Stephan Willems of University Heart Center, Hamburg, Germany will present initial results of the international DDRAMATIC SVT study evaluating the AcQMap system in patients with supraventricular tachycardia on May 12 at 2:00pm CT. A total of six additional presentations will be featured at the meeting highlighting the use of ElectroFunctional™ procedures in patients with both atrial fibrillation and supraventricular tachycardia.

“Acutus has seen incredible momentum over the past twelve months with significant clinical and regulatory milestones under our belt,” said Randy Werneth, President and Chief Executive Officer of Acutus. “As we build our differentiated portfolio of products, we are thrilled to have had data accepted for several presentations that underscore the positive impact of our technology. We believe these data and case studies will shed more light on the unmet need AcQMap can fill by offering patient-specific therapy guidance for people with complex arrhythmias.”

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