Acutus Medical Announces FDA Clearance of Second-Generation AcQMap 3D Imaging & Mapping Catheter
September 17 2020 - 4:01PM
Acutus Medical (Nasdaq: AFIB) today announces FDA 510(k) clearance
of the second-generation AcQMap® 3D imaging and mapping catheter
which builds on its predecessor, improving handling and
deliverability. This flagship 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 the cornerstone of Acutus’
innovative mapping platform. It is the world’s only 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 sterilizable cable that can be used up to
10 times, resulting in greater cost savings for health care
systems.
Customer feedback during development suggested that
users perceived anatomy reconstruction to be faster than our
generation one catheter*. Dr. Anil Rajendra from Grandview Medical
Center in Birmingham, Alabama 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. 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 3 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, Inc. “We are
committed to partnering with physicians to continually provide
products and solutions to address physicians unmet needs.”
*Acutus Medical data on file.
About Acutus Medical Acutus Medical is an
arrhythmia management company focused on improving the way cardiac
arrhythmias are diagnosed and treated. Acutus is committed to
advancing the field of electrophysiology with a unique array of
products and technologies which will enable more physicians to
treat more patients more efficiently and effectively. Through
internal product development, acquisitions and global partnerships,
Acutus has established a global sales presence delivering a broad
portfolio of highly differentiated electrophysiology products that
provide its customers with a complete solution for catheter-based
treatment of cardiac arrhythmias in each of its geographic markets.
Founded in 2011, Acutus is based in Carlsbad, California.
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