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Acutus Medical FDA Clearance

Acutus Medical Announces FDA Clearance, Commercial Launch of AcQCross™ Line Extension Compatible with Watchman™ Delivery System

CARLSBAD, Calif., June 27, 2022 (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 commercial launch of an expanded suite of left-heart access products to now include the AcQCross™ Qx system for use with the TruSeal (TM) and FXD(TM) delivery system for the Watchman™ LAAC Device.

Gaining access to the left atrium requires physicians to cross the septum, a multi-step process that often involves the exchange of wires and needles while trying to achieve the proper angle and location on the septum. AcQCross is the first and only transseptal system engineered with an integrated needle and dilator to reduce these exchanges. US Left-atrial appendage closure procedures are expected to total over 50,000 in 2022, according to the Millennium Research Group. With this clearance, Acutus now offers sheath-compatible transseptal access devices that cover 409,000 electrophysiology and structural heart procedures in the US.

“Crossing the septum at the proper location is important when doing any left-sided heart procedure, but it can be especially critical to the success of delivering Watchman to the left atrial appendage,” said Dr. Tom Waggoner, DO, FACC, FSCAI, FSVM, RPVI, Director, Structural Heart Program and Cardiovascular Research, Tucson Medical Center, Tucson, Arizona. “With AcQCross, I can easily reposition without withdrawing or exchanging needles or wires, so its new compatibility with Watchman has made my procedures much safer for my patients and far more efficient for me and my team.”

AcQCross features an array of catheters that are length-, diameter- and tip-matched and designed to lock into the hub of market-leading sheaths used in the vast majority of left-heart procedures, including delivery of the Watchman. With the expanded product offering, physicians can utilize AcQCross with their preferred sheaths during virtually any left-heart access procedure.

“The AcQCross system provides interventional cardiologists and electrophysiologists with unique benefits of broad compatibility with market-leading access sheaths while also enhancing procedure versatility and workflow,” said David Roman, interim Chief Executive Officer and Chief Financial Officer, Acutus Medical. “The expanded AcQCross product line allows us to bring this innovative technology to a wider range of procedure categories that should drive sustained growth in this portfolio.”

AcQCross and its entire line of catheters are commercially available in the United States. For more information, visit www.acutusmedical.com/us/.

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.

Sale of Left-Heart Access Portfolio to Medtronic
On April 27, 2022, Acutus announced a definitive agreement to sell its left-heart access portfolio to Medtronic. Under the terms of the agreement, Medtronic will make an upfront cash payment to Acutus of $50 million upon the initial closing of the transaction, subject to the satisfaction of customary closing conditions, including expiration or early termination of all applicable waiting periods (and any extensions thereof) under applicable antitrust laws, and the closing of the Company’s debt refinancing, as well as contingent consideration payments over time based on the achievement of certain milestones and future sales.

Follow Acutus Medical on: Twitter, LinkedIn, YouTube and Facebook. 

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

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

Acutus Medical Announces FDA Clearance

Source: Acutus Medical, Inc.

2022 GlobeNewswire, Inc., source Press Releases

Disclaimer: This content is only intended for informational purposes. Before making any investment, you should always do your own research and analysis.
 
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