ABT Stock to Gain From Early CE Mark Approval of Volt PFA System

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Abbott ABT recently announced CE Mark approval for the Volt Pulsed Field Ablation (“PFA”) system to treat patients battling atrial fibrillation (AFib). The development came earlier than expected, allowing the company to begin commercial PFA cases in the European Union (“EU”) with physicians who have already gained experience with the Volt PFA system within its PFA clinical studies.

The company will further expand the use of Volt in EU markets throughout the second half of this year.

ABT Stock’s Likely Trend Following the News

After the announcement on March 27, Abbott shares rose 3.7%, closing at $131.35. The company’s EP portfolio has been seeing well-balanced growth across the United States and international markets. The introduction of the Volt PFA system marks a pivotal moment for electrophysiology in Europe. We expect the market sentiment toward ABT stock to remain positive surrounding this development.

Abbott holds a market capitalization of $226.88 billion. The company’s earnings yield of 3.9% surpasses the industry’s average yield of 0.3%. ABT delivered an average earnings beat of 1.6% in the trailing four quarters.

Relevance of Abbott’s Volt PFA System and Latest Approval

People living with AFib face an increased risk of stroke, heart failure and death, and many rely on cardiac ablation to treat the condition effectively. A relatively new therapy option, PFA works differently from traditional ablation approaches by delivering high-energy electrical pulses to targeted areas of cardiac tissue, causing abnormal heart rhythms. As a result, it can reduce the risk of damaging adjacent tissue in patients with complex diseases or anatomy. Still, current on-market competitive PFA systems require several therapy applications with a catheter positioned in various locations due to a lack of visualization or contact assessment.

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Abbott’s Volt PFA System builds upon its electrophysiology (EP) portfolio by providing a single-catheter PFA approach, improving workflow by allowing for mapping, pacing and ablating with a single catheter to safely and effectively treat patients with AFib.

The approval is based on strong results from the Volt CE Mark study, a global clinical trial conducted at centers in Europe and Australia. The trial showed that the system achieved pulmonary vein isolation (PVI) — the method of destroying tissue causing a patient's AFib — in 99.1% of veins during ablation procedures with far fewer energy applications than on-market competitive PFA systems.