Catheter for mapping, imaging before ablation receives FDA clearance
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Acutus Medical announced that a second-generation 3D imaging and mapping catheter for atrial arrhythmias received 510(k) clearance from the FDA.
The catheter (AcQMap) produces high-definition maps to help clinicians identify ablation targets and plan an ablation strategy, according to a press release from the company. This technology allows clinicians to map an arrhythmia under 3 minutes with 48 ultrasound transducers to create anatomical geometry and 48 engineered electrodes to display electrical activation patterns of the inner surface of the heart. This catheter is also compatible with a 0.035-inch guidewire for insertion into the left and right atrium.
This catheter can capture cardiac imaging information and cardiac activation mapping, according to the release. The second-generation catheter also allows faster acquisition times, improved anatomy reconstruction and the potential for enhanced procedural proficiencies.
“The ergonomic handle and catheter deployment mechanism has the potential to allow me to maneuver the catheter with great speed, ease and control,” Anil Rajendra, MD, cardiologist at Grandview Medical Center in Birmingham, Alabama, said in the release.
A reusable and sterilizable cable for the catheter can be used up to 10 times, which contributes to cost savings for health care systems.
“We pride ourselves on our continued and rapid cadence of bringing innovative, differentiated technologies to the market,” Vince Burgess, president and CEO of Acutus Medical, said in the release. “We are committed to partnering with physicians to continually provide products and solutions to address physicians’ unmet needs.”
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