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Acutus Medical Announces CE Mark Approval for Suite of Next Generation EP Products in Europe | ||
By: GlobeNewswire - 12 May 2021 | Back to overview list |
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Expanded and Product Portfolio Strengthens Offering in Access and Therapy Guidance CARLSBAD, Calif., May 12, 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 CE Mark Approval for a broad suite of EP products that includes the AcQCross™ family of universal transseptal crossing devices, the next generation AcQGuide® MAX and VUE large bore delivery sheaths and the next generation AcQMap® mapping catheter. These products are designed to streamline procedural workflow in all left heart procedures and further improve ease-of-use of Acutus’ proprietary non-contact mapping technology, which allows electrophysiologists to quickly and accurately map the most complex atrial arrhythmias in minutes. “Our R&D investments are translating into meaningful clinical innovations, as we build a comprehensive portfolio of therapy management solutions that make procedures safer, simpler and more effective,” said Vince Burgess, President and CEO of Acutus Medical. “We remain steadfast in our commitment to improve the treatment of complex atrial arrhythmias, and the European launch of our next generation access and diagnostic technologies is another step in that direction.” Today’s approvals expand on the company’s extensive therapy guidance and ablation product lines already approved in Europe. Newly CE marked products include:
In Europe, there are approximately 350,000 cardiac ablations annually. This procedure volume is expected to grow to 475,000 by 20252. The increasing prevalence of complex arrythmias and the associated burden on patients and healthcare providers requires new solutions from access to diagnosis to therapy. The AcQCross Universal Transseptal Access System and the second-generation AcQMap 3D imaging and mapping catheter are now commercially available in Europe and the United States. The AcQGuide VUE and second generation AcQGuide MAX are approved in Europe but are not cleared for sale in the United States. For more information, visit www.acutusmedical.com/us/. References About Acutus Medical Follow Acutus Medical on: Twitter, LinkedIn, and Facebook. US Media Contacts Levitate Investor Contact Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/037e4658-63c8-499f-9572-e54765e04d53 https://www.globenewswire.com/NewsRoom/AttachmentNg/0c34648d-d949-485a-a4a8-78c649033f67 https://www.globenewswire.com/NewsRoom/AttachmentNg/e5148113-e900-4341-8481-d656011cb7b1 |
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