Acutus Medical Launches AcQBlate® Force Sensing Ablation System in Europe

Rhea-AI Summary

Acutus Medical has received CE Mark approval for its AcQBlate^® Force Sensing Ablation System, which includes the first commercially available gold-tipped, irrigated, force-sensing catheter. This innovative system enhances real-time contact force measurements during cardiac ablation procedures, potentially improving patient outcomes. The AcQBlate FORCE system integrates the Qubic RF generator and Qiona irrigation pump, offering a comprehensive electrophysiology solution. Acutus aims to advance cardiac arrhythmia treatment with this cutting-edge technology across Europe.

Positive

• CE Mark approval for AcQBlate Force Sensing Ablation System expands product portfolio in Europe.
• Features the first gold-tipped, force-sensing ablation catheter, enhancing treatment efficacy.
• Real-time contact force sensing may improve patient outcomes during cardiac procedures.
• Integration with Qubic RF generator and Qiona irrigation pump provides a complete setup for electrophysiologists.

Negative

• AcQBlate Force Sensing Catheter is not available for sale in the United States, limiting market access.

Gold-Tipped Force Sensing Ablation Catheter Earns CE Mark, Expanding Acutus’ Comprehensive Electrophysiology Portfolio

CARLSBAD, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the launch of the AcQBlate^® Force Sensing Ablation System in Europe after securing CE Mark for the company’s AcQBlate FORCE ablation catheter and the Qubic Force Sensing Module (Qubic Force). The AcQBlate Force Sensing Ablation System, which incorporates the first and only commercially available gold-tipped, irrigated, force-sensing radiofrequency ablation catheter on the market (AcQBlate Force^®), also integrates two state-of-the-art components made available through Acutus Medical’s international alliance with BIOTRONIK:

• the Qubic Radiofrequency Generator (Qubic RF)
• the Qiona Irrigation Pump

When combined with AcQMap^®, Acutus’ proven ultra-high resolution, 3D cardiac imaging and mapping system, the AcQBlate Force Sensing Ablation System represents a complete and highly differentiated solution for the electrophysiologic (EP) mapping and RF ablation of cardiac arrhythmias.

Designed specifically to provide innovative therapeutic solutions during cardiac ablation procedures, AcQBlate FORCE shows physicians, in real time, how much contact is being applied to the heart during ablation procedures. Studies have shown the utility of real-time contact force information in helping physicians guide safe and effective therapy, which may improve patient outcomes¹. AcQBlate FORCE also uses an innovative single optical fiber-based force sensor in an isolated tip with active temperature compensation that results in accurate and reliable contact force measurements at all contact angles during an ablation procedure.

“It is important that physicians know how much force is being applied to the wall of the heart during ablation procedures,” said Dr. Tamas Szili-Torok of Erasmus Medical Center in Rotterdam, Netherlands. “AcQBlate FORCE is a unique and differentiated product that will easily surpass expectations in providing a therapeutic solution. The AcQBlate FORCE catheter combines the benefits of optical force sensing technology, a gold ablation electrode, and a novel irrigation design to enable effective lesion formation at lower irrigation rates.”

In addition to contact force sensing technology, the AcQBlate FORCE gold-tip technology may improve workflow efficiency through greater thermal conductivity compared to conventional platinum-iridium electrodes. This superior thermal property results in more efficient energy delivery and decreased tip temperature at half the irrigation rates of conventional force sensing catheters. Gold-tip catheters can create the same lesion characteristics in less time compared to platinum-iridium tips.^2,3

The AcQBlate FORCE ablation catheter is paired with the Qubic Force Module that translates the contact force signal into an intuitive real-time display of contact force and contact force angle that a physician may use to navigate the cardiac anatomy and deliver therapy with confidence. The Qubic RF generator and the Qiona irrigation pump, available through Acutus Medical’s partnership with BIOTRONIK, complete the AcQBlate Force Sensing Ablation System. The Qubic RF generator has the smallest footprint of any radiofrequency ablation generator in its class and a unique control interface that minimizes the number of steps and settings required to start an ablation procedure. The Qubic RF generator integrates with the Qiona irrigation pump to automatically deliver the right amount of irrigation flow through the catheter during RF ablation. The AcQBlate Force Sensing Ablation System may also operate in a “standalone” manner, enabling physicians the benefit of contact force sensing technology even in simple ablation cases where sophisticated 3D diagnostic mapping may not be required.

Dangerous and potentially life-threatening cardiac arrhythmias are often treated with cardiac ablation procedures that require robust tools including access, diagnostic, and therapeutic technologies. Acutus Medical offers a full suite of EP solutions on an open platform, including transseptal access and advanced cardiac imaging and mapping, in addition to the new Force Sensing Ablation System.

“We are excited to offer this innovative and fully integrated therapeutic solution,” said Vince Burgess, CEO of Acutus Medical. “AcQBlate FORCE’s capabilities reflect everything we’re trying to accomplish at Acutus – the creation and delivery of EP products that are both state-of-the-art and designed to work in virtually any setting due to their open platform design. Open platforms help accelerate innovation and drive cost effective solutions that ultimately benefit all. We look forward to offering the benefits of a comprehensive, force sensing ablation system to electrophysiologists in Europe and, ultimately, around the world.”

AcQBlate Force Sensing Catheter is not for sale in the United States

References
¹ Ariyarathna N. et al., Role of Contact Force Sensing in Catheter Ablation of Cardiac Arrhythmias: Evolution or History Repeating Itself? JACC: Clinical Electrophysiology (2018); 707-723
² Tibor Balázs et.al, Ablation time efficiency and lesion volume. Journal of Interventional Cardiac Electrophysiology (2012), (36).
³ Linhart M. et al., Superiority of Gold Compared to Platinum Tip Irrigated Catheter Ablation of the Pulmonary Veins and the Cavotricuspid Isthmus: A Randomized Study Comparing Tip Temperatures and Cooling Flow Requirements. J Cardiovasc Electrophysiol. 2012 Jul; 23(7): 717–21

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 Contacts
Levitate
(260) 408-5383
acutus@levitatenow.com

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

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/5e31a3d6-9679-4d6b-9931-914215641e0e

https://www.globenewswire.com/NewsRoom/AttachmentNg/b1caea43-b941-4c6f-ac16-feb80962085c

FAQ

What is the significance of the CE Mark for Acutus Medical's AcQBlate system?

The CE Mark allows Acutus Medical to market its AcQBlate Force Sensing Ablation System in Europe, enhancing its product portfolio.

How does the AcQBlate FORCE system improve cardiac ablation procedures?

The system provides real-time contact force measurements, which can lead to safer and more effective ablation therapy.

What are the components of the AcQBlate Force Sensing Ablation System?

The system includes the AcQBlate FORCE catheter, Qubic RF generator, and Qiona irrigation pump.

Is the AcQBlate Force Sensing Catheter available in the United States?

No, the AcQBlate Force Sensing Catheter is not for sale in the United States.

What is the expected impact of the AcQBlate system on electrophysiology practices?

The AcQBlate system is expected to enhance workflow efficiency and improve patient outcomes in electrophysiology practices.