Abbott Laboratories announced that the U.S. Food and Drug Administration approved its Volt™ Pulsed Field Ablation (PFA) System on December 22, 2025, clearing the company to begin commercial use of the device in the United States. The approval follows a 392‑patient IDE study that demonstrated strong safety and effectiveness in both paroxysmal and persistent atrial fibrillation cases, with a 95% success rate and minimal complications.
The Volt PFA System is a single‑catheter platform that integrates mapping, pacing, and ablation. Its balloon‑in‑basket design delivers focused, non‑thermal energy, allowing procedures to be performed with fewer catheter exchanges and potentially under conscious sedation. The study data, presented at the 2025 Heart Rhythm Society meeting, showed that the system reduced procedure time by an average of 20 minutes compared with conventional radiofrequency ablation, and patients experienced faster recovery and fewer post‑procedure complications.
From a market perspective, the U.S. atrial fibrillation device market is projected to grow from $9.2 billion in 2024 to over $20.7 billion by 2033, a CAGR of 9.5%. Abbott’s entry with the Volt PFA System positions it to capture a share of this expanding market and to compete directly with Medtronic, Boston Scientific, and Johnson & Johnson, all of whom already offer pulsed‑field devices. The approval also strengthens Abbott’s broader electrophysiology portfolio, which has seen double‑digit growth in international ablation catheter sales in the third quarter of 2024.
Abbott’s recent financial performance underscores the strategic importance of the new device. In the fourth quarter of 2024, the company reported sales of $10.9 billion, up 3% from the prior year, and an adjusted diluted EPS of $1.34, reflecting a 23% operating margin that improved by 40 basis points from the third quarter of 2025. The company’s guidance for 2025 projects organic sales growth of 7.5%–8.5% and adjusted diluted EPS of $5.05–$5.25, indicating confidence in continued momentum across its medical device segments. The Volt PFA System is expected to contribute to this growth by expanding Abbott’s presence in a high‑margin, high‑growth specialty market.
Management emphasized the approval’s significance in a statement from Chairman and CEO Robert Ford, who noted that the device “demonstrates Abbott’s commitment to innovative, patient‑centric solutions that improve outcomes and streamline workflows.” Analysts highlighted the early‑market entry as a competitive advantage, noting that the approval arrived ahead of the expected first‑half 2026 authorization for other competitors. The market reaction reflected confidence in Abbott’s ability to capture market share and drive future revenue growth.
In addition to the regulatory milestone, Abbott’s board approved a 6.8% increase in its quarterly dividend, marking the 54th consecutive year of dividend growth. The dividend hike signals the company’s confidence in its cash‑flow generation and its commitment to returning value to shareholders while investing in growth initiatives such as the Volt PFA System.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.