Acutus Medical wins FDA nod for AcQGuide steerable sheath

Acutus Medical said today it won FDA 510(k) clearance for its AcQGuide steerable sheath percutaneous catheter.

The AcQGuide steerable sheath is designed to provide additional maneuverability to catheters which are advanced through the sheath and into the right or left chambers of the heart, the Carlsbad, Calif.-based company said.

“Acutus has seen incredible momentum over the past twelve months with significant clinical and regulatory milestones under our belt. 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,” prez & CEO Randy Werneth said in a press release.

Acutus said that it is currently pursuing FDA clearance for its AcQMap high resolution imaging and mapping system, including its AcQMap 3D imaging and mapping catheter.

The company won CE Mark approval for the AcQMap last May, and launched a trial of the device in October.

The 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.

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