Acutus Medical Announces FDA Clearance of AcQCross™, a Full Suite of Universal Transseptal Crossing Devices

Rhea-AI Summary

Acutus Medical announced FDA clearance for the AcQCross™ family of universal transseptal crossing devices, targeting over 300,000 annual U.S. electrophysiology and structural heart procedures. This is the first system designed for seamless compatibility with both Acutus and other manufacturers' sheaths. The product aims to enhance procedural efficiency by eliminating wire and needle exchanges, simplifying transseptal crossing for atrial fibrillation and related procedures. The full U.S. commercial launch is set to begin shortly.

Positive

• FDA clearance obtained for AcQCross devices, allowing access to a significant market of over 300,000 annual procedures.
• Unique product features streamline procedures by eliminating wire and needle exchanges, enhancing efficiency.
• Designed for compatibility with a wide range of existing sheaths, facilitating widespread adoption by physicians.

Negative

• None.

Product Family Targets Over 300,000 Annual US Electrophysiology and Structural Heart Procedures

CARLSBAD, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the FDA clearance of the AcQCross™ family of universal transseptal crossing devices. This is the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ own suite of sheaths and with sheaths sold by other manufacturers. In the United States, there are over 300,000 electrophysiology (EP) and structural heart procedures per year involving the use of transeptal crossing devices^1,2,3. The company will initiate its full US commercial launch of AcQCross in the coming weeks.

Crossing the septum to gain access to the left atrium of the heart is a critical and required step in any atrial fibrillation or left sided tachycardia ablation procedures as well as in many left sided structural heart procedures (such as left atrial appendage closure device implants or percutaneous mitral valve repair). Achieving the proper crossing angle and location of septal crossing can significantly impact the efficiency of the entire procedure.

The new and expanded family of AcQCross catheters include versions that are length-, diameter- and tip-matched and designed to lock into the hub of sheaths now used in the vast majority of left heart procedures, including those provided by Acutus and by other vendors. This unique compatibility allows physicians to utilize AcQCross with their sheath of choice during virtually any left heart procedure.

AcQCross enables mechanical septal crossing with a spring-loaded needle that can also be enhanced with concurrent delivery of radiofrequency (RF) energy. AcQCross further streamlines procedural workflow by eliminating the need for wire and needle exchanges, as it incorporates a retained .032 guidewire within the hollow crossing needle.

“The elimination of guidewire and needle exchanges is an important step in facilitating transseptal crossing procedures,” said Dr Peter Weiss MD, MSC, Director of Ventricular Arrythmia Management and Robotics, Assistant Professor of Medicine, Banner University of Arizona Medical Center Phoenix. “The optimal septal crossing location and angle differs depending on the procedure – be it Cryoablation, RF ablation, non-contact mapping or left atrial appendage implant – so the unique ability to easily reposition without cumbersome catheter withdrawals and exchanges are benefits that cannot be overstated. As physicians, we rely on meaningful device innovation that fits into our existing procedural workflow and provides improvement. Acutus is delivering that with AcQCross.”

“This product is absolutely unique in the industry. We are giving physicians an immensely adaptable and versatile product family developed to provide an enhanced and more precise transseptal approach – and still allow them to continue to use their sheath of choice for the remainder of the procedure,” said Vince Burgess, President and CEO of Acutus Medical. “We expect that this product will be quickly and widely adopted by electrophysiologists and interventional cardiologists.”

AcQCross is now commercially available in the United States. For more information, visit www.acutusmedical.com/us/.

References
¹2019 Millennium Research Group: Electrophysiology Mapping and Ablation Devices | Market Analysis |US | 2019
²American College of Cardiology – The NCDR Left Atrial Appendage Occlusion Registry
³Transcatheter Cardiology Therapeutics (TCTMD), American Heart Association Database

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

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

Investor Contact
Caroline Corner
415-202-5678
caroline.corner@westwicke.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/34afae1d-86f9-41a4-a8d4-50411cc4787c

FAQ

What is the AcQCross™ family of devices?

The AcQCross™ family consists of universal transseptal crossing devices designed for seamless use with various sheaths in electrophysiology and structural heart procedures.

When did Acutus Medical receive FDA clearance for AcQCross?

Acutus Medical announced the FDA clearance for the AcQCross™ family of devices on April 13, 2021.

How many procedures does the AcQCross target annually in the U.S.?

The AcQCross targets over 300,000 annual electrophysiology and structural heart procedures in the United States.

What benefits does AcQCross provide for medical procedures?

The device eliminates the need for wire and needle exchanges, simplifying transseptal crossing and enhancing procedural efficiency.

When will AcQCross be commercially available?

The AcQCross is now commercially available in the United States, with a full launch expected soon.