Abbott’s Volt PFA system gains CE Mark for AFib treatment

Published 27/03/2025, 14:06
Abbott’s Volt PFA system gains CE Mark for AFib treatment

ABBOTT PARK, Ill. - Abbott (NYSE: ABT), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $219.58 billion, has received CE Mark approval for its Volt PFA System, designed to treat atrial fibrillation (AFib), and has initiated commercial cases in the European Union (EU). According to InvestingPro data, the company maintains a strong financial health score of GOOD, supporting its continued innovation in medical technology. Physicians who participated in Abbott’s clinical studies are the first to use the system, with broader EU market expansion planned for the second half of the year.

The Volt PFA System is part of Abbott’s electrophysiology portfolio and offers a single-catheter approach to cardiac ablation, a procedure for AFib treatment. The system aims to improve workflow and ensure effective treatment by enabling mapping, pacing, and ablating with a single catheter.

Approval was based on the Volt CE Mark study, showing a 99.1% success rate in achieving pulmonary vein isolation with fewer energy applications than other PFA systems on the market. Initial cases were conducted by leading physicians across Europe, including Austria, Germany, Belgium, and the Netherlands.

The system integrates with Abbott’s EnSite X EP system, enhancing procedural workflow, energy delivery, and procedural flexibility. It allows for real-time contact visualization, which helps with accurate catheter positioning.

Abbott’s electrophysiology business CMO, Christopher Piorkowski, M.D., emphasized that the Volt PFA System incorporates improvements from first-generation devices and has demonstrated fewer ablation attempts and therapy applications in clinical data, leading to better patient outcomes. This innovation contributes to Abbott’s robust business performance, with the company generating $41.95 billion in revenue over the last twelve months. InvestingPro analysis reveals 10+ additional insights about Abbott’s market position and growth potential.

The Volt PFA System is also under study in the VOLT-AF Investigational Device Exemption (IDE) Study, which completed enrollment ahead of schedule last year. Additionally, Abbott has made progress in clinical studies for its focal PFA technology and recently received regulatory approval in the U.S. and Europe for a new sizing of its Agilis NxT Steerable Introducer, enhancing compatibility with larger catheters used for PFA therapy.

Abbott, a global healthcare leader, offers a wide range of technologies across diagnostics, medical devices, nutritionals, and branded generic medicines. The company has maintained dividend payments for 55 consecutive years and operates with moderate debt levels, demonstrating strong financial stability. For detailed analysis and comprehensive insights, investors can access Abbott’s full Pro Research Report, available exclusively on InvestingPro, along with data on 1,400+ other top US stocks. The information in this article is based on a press release statement and InvestingPro data.

In other recent news, Abbott Laboratories has been granted an investigational device exemption by the U.S. Food and Drug Administration (FDA) for its Coronary Intravascular Lithotripsy (IVL) System, allowing the commencement of the TECTONIC clinical trial. This trial will evaluate the system’s efficacy in treating severe arterial calcification in patients with Coronary Artery Disease. Meanwhile, Abbott Laboratories continues to receive positive analyst attention, with TD Cowen maintaining a Buy rating and a $135 price target, citing the company’s compliance with new infant formula safety initiatives. Similarly, BofA Securities has reiterated its Buy rating and $150 target, emphasizing Abbott’s strong fundamentals and durable revenue growth. Citi has also maintained a Buy rating with a $160 target, despite recent legal developments involving a retrial in the Whitfield infant formula case. The company is facing its own federal multidistrict litigation scheduled for May 2025, which is being closely watched by investors. Despite these legal challenges, analysts remain confident in Abbott’s financial performance and resilience. These developments highlight Abbott’s ongoing efforts to advance its medical technologies and maintain stability in its operations.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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