Imaging, mapping system cleared for use in catheter ablation
Acutus Medical announced that its high-resolution imaging and mapping system and catheter have been cleared by the FDA for use in electrophysiology procedures.
The technology (AcQMap high resolution imaging and mapping system, and AcQMap 3-D imaging and mapping catheter) uses ultrasound to enable operators to visualize cardiac anatomy and dipole density, and to map the pathway of each heartbeat, according to a press release from the company.
Operators can re-map the heart in seconds after each ablation treatment to see any changes from the prior mapping, according to the release.
Clearance was supported by safety results from the DDRAMATIC-SVT trial, and the technology has been cleared for use in Europe for 2 years, the company stated in the release.
“The AcQMap system is able to provide global dipole density mapping of irregular and chronic activation in the atrial chambers, whereas conventional sequential mapping may struggle to provide us with the information that is required,” Tom Wong, MD, consultant cardiologist and electrophysiologist at Royal Brompton Hospital in London, said in the release. “In the cases we have performed thus far, real-time mapping of complex arrhythmias has allowed us to focus on the areas of interest and terminate the arrhythmia using ablation therapy. We can now offer individualized, tailored therapy, and are one step closer to identifying the mechanisms of complex arrhythmias.”
The technology will be commercially available in the U.S. in early 2018, according to the release.
Disclosure: Wong reports no relevant financial disclosures.