US FDA approval for second generation AcQMap system

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Acutus Medical has announces US Food and Drug Administration (FDA) 510(k) clearance of the second-generation AcQMap 3D imaging and mapping catheter which builds on its predecessor, improving handling and deliverability. The 3D mapping and navigation catheter combines 48 ultrasound transducers responsible for creating the anatomical geometry and 48 engineered electrodes which enable electrical activation patterns to be displayed along the inner surface of the heart. Compatible with an 0.035” guidewire, the AcQMap catheter is designed to be inserted into the left and right atrium.

The AcQMap catheter is an integrated high-resolution ultrasound-based imaging and non-contact mapping catheter capable of capturing cardiac imaging information in addition to cardiac activation mapping. This second-generation catheter carries additional benefits such as improved anatomy reconstruction, faster acquisition times and the potential for enhanced procedural efficiencies. The catheter also comes with a reusable and sterilisable cable that can be used up to 10 times.

Customer feedback during development suggested that users perceived anatomy reconstruction to be faster than our generation one catheter, Acutus Medical said in a press release. Anil Rajendra, Grandview Medical Center, Birmingham, USA, commented: “The new ergonomic handle and catheter deployment mechanism has the potential to allow me to maneuver the catheter with greater speed, ease and control.”

The versatility of the AcQMap System allows physicians to map all types of atrial arrhythmias—simple and complex, spontaneous, repetitive and chaotic, Acutus Medical’s press release adds. The high definition maps provided by the AcQMap catheter allow physicians to identify ablation targets outside the pulmonary veins and strategically plan a patient-specific ablation strategy. Physicians can efficiently map any arrythmia in under three minutes, ablate and then remap again to evaluate therapy effectiveness.

“At Acutus, we pride ourselves on our continued and rapid cadence of bringing innovative, differentiated technologies to the market,” said Vince Burgess, president & CEO of Acutus Medical. “We are committed to partnering with physicians to continually provide products and solutions to address physicians unmet needs.”


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