Acutus Medical Announces CE Mark and European Launch of AcQCross™ Transseptal System, a Fully Integrated Family of Transseptal Crossing Products

Rhea-AI Summary

Acutus Medical (Nasdaq: AFIB) announced the launch of its AcQCross Transseptal System in Europe following the CE Mark approval, enhancing access to the left atrium for cardiac procedures. This system reduces the need for multiple exchanges during procedures like atrial fibrillation ablation, improving efficiency and safety. It is compatible with existing Valleylab generators, further lowering costs for healthcare facilities. The product demonstrates strong demo-to-conversion rates and shows promise in global sales growth despite ongoing challenges from Covid.

Positive

• Successful CE Mark and European launch of the AcQCross Transseptal System.
• Product designed to improve procedural efficiency by reducing exchange requirements.
• Strong demo-to-conversion rates noted across various customer segments.
• Continued sales growth in the US transseptal crossing market.

Negative

• None.

Designed to Improve Safety and Efficiency in Any Procedure Requiring Left Heart Access

CARLSBAD, Calif., Dec. 10, 2020 (GLOBE NEWSWIRE) -- 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.

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• Twitter: @AcutusMedical
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US Media Contacts
Levitate
(260) 408-5383
acutus@levitatenow.com

Holly Windler
619-929-1275
holly.windler@acutus.com

FAQ

What is the AcQCross Transseptal System launched by Acutus Medical?

The AcQCross Transseptal System is designed to improve access to the left atrium and enhance procedural efficiency during cardiac interventions.

What regulatory approval has Acutus Medical received for its transseptal crossing products?

Acutus Medical has received CE Mark approval for its transseptal crossing products, enabling its launch in Europe.

How does the AcQCross System benefit cardiac procedures?

The system allows for fewer exchanges during procedures, enhancing safety and efficiency for electrophysiology and structural heart interventions.

What is the stock symbol for Acutus Medical?

The stock symbol for Acutus Medical is AFIB.