Acutus Medical Announces CE Mark and European Launch of AcQCross™ Transseptal System, a Fully Integrated Family of Transsep...
December 10 2020 - 8:00AM
Acutus Medical (Nasdaq: AFIB), an arrhythmia management company
focused on improving the way cardiac arrhythmias are diagnosed and
treated, today announced CE Mark and European launch of their
integrated family of transseptal crossing products, designed to
deliver safe and efficient access to the left atrium. Coupled with
their previously received FDA clearance, Acutus now has regulatory
approval to gain access to key global geographies in the large and
growing market for transseptal crossing products.
The AcQCross Transseptal System includes the AcQCross Qx
packaged with either the fixed AcQGuide™ MINI or steerable AcQGuide
FLEX introducer sheath. The AcQCross Qx is comprised of an
integrated needle and dilator that supports the passthrough of an
0.032” guidewire, allowing the guidewire to always be loaded during
left atrial access. Physicians now have the ability to position,
reposition, and cross the atrial septum without removing the
guidewire, thereby reducing the number of exchanges required for a
variety of electrophysiology and structural heart procedures,
including: atrial fibrillation ablations, left atrial appendage
closure, and transcatheter mitral valve repair and replacement.
This versatile system not only offers manual and safe crossing
with a spring-tension needle but also provides the option to use RF
energy to facilitate septal crossing in patients with challenging
anatomy. The system is compatible with Valleylab® generators which
are already present in most labs and operating rooms, eliminating
the need for and cost associated with proprietary RF
generators.
“The AcQCross Transseptal System greatly enhances
my procedural efficiency by reducing the number of exchanges,”
commented Dr. Jose Osorio from Grandview Medical Center in
Birmingham, Alabama. “I particularly appreciate the ability to
quickly reposition the catheter tip to allow for optimizing the
septal crossing location on the fossa, as angle of approach can
have an important impact on the speed and quality of ablations and
implants.”
“This is a terrific product line and we are seeing
really impressive demo-to-conversion rates across the full spectrum
of customer segments,” said Vince Burgess, President and CEO of
Acutus Medical, Inc. “As we mentioned on our last quarterly update,
our US transseptal crossing sales have been growing steadily.
Despite the continuing Covid headwinds, we remain encouraged by
adoption trends in the US and, with our CE Mark now in hand, we
look forward to building sales in additional geographies.
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.
Follow Acutus Medical
on:
- Twitter: @AcutusMedical
- LinkedIn: www.linkedin.com/company/acutus-medical-inc-/
- Facebook: @AcutusMedical
US Media ContactsLevitate(260)
408-5383acutus@levitatenow.com
Holly Windler619-929-1275holly.windler@acutus.com
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