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Acutus Medical reports first cardiac procedure with AcQMap system in US

MDBR Staff Writer Published 09 May 2018

Acutus Medical announced that the first cardiac procedure with AcQMap high resolution imaging and mapping system has been performed in US patients.

The firm also started new clinical study for the assessment of technology during atrial fibrillation retreatment ablation procedures in Europe and Canada.

According to the company, the AcQMap system has been used to perform more than 500 procedures at 15 European centers.

AcQMap high resolution imaging and mapping system detects and shows both standard voltage-based and higher resolution dipole density-based maps of the heart.

The system aggregates ultrasound anatomy construction with an ability to map the electrical-conduction of each heartbeat to detect complex arrhythmias across the entire atrial chamber

Acutus Medical chairman, president and CEO Vince Burgess said: "Enabling physicians to see complex, irregular arrhythmias in real-time should provide important new insights and enable truly personalized and individualized ablation therapy planning. 

“We hope that this unique capability, combined with the ability to quickly re-map after each ablation, will lead the way to further improvements in clinical outcomes for patients suffering from complex arrhythmias.”

Acutus recruited first patient in the Recover AF clinical study, which is a prospective, single-arm and multi-center trial designed to offer clinical data related with the use of AcQMap system during first or second atrial fibrillation retreatment ablation procedures. 

The company is planning to recruit up to 100 patients in Europe and Canada.

The first procedure with the system was performed by Dr Tim Betts at John Radcliffe Hospital, Oxford University Hospitals in Oxford, UK.

Acutus Medical secured approval from the US Food and Drug Administration (FDA) for its AcQRef introducer sheath for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and to sense intravenous signals.

Strategically placed electrodes along the introducer shaft will serve as a cardiac electrical reference when used in conjunction with the AcQMap system.