Acutus Medical has announced that the AcQMap High-Resolution Imaging and Mapping System has been utilised for the first time in US patients. The company also revealed initiation of a new clinical study to evaluate the technology during atrial fibrillation retreatment ablation procedures in Europe and Canada.
“Enabling physicians to see complex, irregular arrhythmias in real-time should provide important new insights and enable truly personalised and individualised 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,” said Vince Burgess, Chairman, president and CEO, at Acutus Medical. “Together with institutions across the country, we hope to transform the lives of people suffering from complex arrhythmias through our innovative technology and are pleased that US patients now have access to AcQMap.”
The AcQMap System has been used in Europe in 15 centres and in more than 500 procedures.
Clinical Trials
Acutus also announced the first enrollment in the RECOVER AF clinical study. The study is a prospective, single-arm, multi-center trial designed to provide clinical data regarding the use of the AcQMap System during first or second atrial fibrillation retreatment ablation procedures. The RECOVER AF study will enroll up to 100 patients in Europe and Canada.
The first procedure was successfully completed by Tim Betts at John Radcliffe Hospital, Oxford University Hospitals in Oxford, United Kingdom.
“In patients undergoing re-do ablation for persistent AF we often need to look beyond simple pulmonary vein isolation and identify additional electrophysiological mechanisms driving the arrhythmia,” said Betts. “In this particular patient, I was able to map both the left and right atriums, direct my ablation strategy at rotational activity and focal firing and acutely terminate the longstanding persistent AF back to sinus rhythm. Seeing the System’s immediate impact has made me optimistic that this patient will now be free of AF.”
FDA Clearance
The FDA has also cleared the 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 can be used as a cardiac electrical reference when used in conjunction with the AcQMap System.
