2025Year12Month22Day,Global Medical Device LeaderAbbott (NYSE:ABT) Announced itsVoltPulsed Field Ablation (PFA) The system has been approved by the U.S. Food and Drug Administration (FDA) approved for the treatment of patients with atrial fibrillation.

This approval marks Abbott's official entry into the U.S. market.PFAMarket, will cooperate with Medtronic, Boston Scientific, Johnson & Johnson Medical Technologies andKardiumCompanies such as Medtronic (Shanghai) Limited and Abbott Diagnostics Medical Co., Ltd. are engaged in fierce competition.

VoltThe approval in the United States is based onVOLT - AF IDESolid data from the study. The study was large-scale, evaluating data from the United States, Europe, Canada, and Australia.40Central392Number of patients. The results of the study showed,VoltIn paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PersAF) have demonstrated significant clinical implications in terms of safety and efficacy. This outcome providesFDAThe approval provided strong evidence, and also gave the market confidence inVoltare highly anticipated.

Abbott Introduction,VoltUsing a single catheterPFAMethod, aimed at optimizing workflow and enhancing surgical flexibility. It ingeniously integrates the balloon basket catheter withEnSite X EPCombined with the cardiac mapping system.EnSite X EPThe system acts as a "transparent eye" for doctors, helping them achieve clear visualization and precise positioning within the heart.Volt PFATools such as catheters have greatly improved the precision and safety of surgeries.

VoltAs an extension of Abbott's existing electrophysiology product portfolio, it is an all-in-one product. Doctors useVoltCan safely perform mapping, pacing, and ablation operations within the same catheter, greatly simplifying the surgical process. Its balloon basket design offers multiple operation methods, facilitating efficient energy delivery for doctors, allowing direct energy transmission to the target tissue, effectively terminating abnormal cardiac signals.

VoltThe design concept is also reflected in the improvement of workflow. It integratesEnSite X EPTechnology, aimed at supporting effective first-time surgery, reducing the likelihood of repeat ablations, minimizing the risk of complications, while achieving durable lesions with fewer pulses. Additionally, patient useVoltDuring the surgery, there is no need for general anesthesia; the treatment can be performed under conscious sedation. It also helps reduce radiation exposure (fluoroscopy) and limits red blood cell destruction (hemolysis), providing patients with a higher quality and safer surgical experience.

Christopher, Chief Medical Officer of Abbott's Electrophysiology Business· Dr. Piorkowski said: "We have fully listened to the feedback from doctors, who believe that patients should undergoPFAA method that can replace general anesthesia without affecting the surgical outcome is needed during ablation surgery.Volt PFAThe system offers an ideal option for patients who prefer conscious sedation, which can not only accelerate patient recovery but also shorten operation time, benefiting millions of Americans with arrhythmia."

Executive Medical Director of the Kansas City Heart Rhythm Institute, one of the first in the U.S. to useVoltOne of the Doctors of the Ablation SystemDJ LakkireddyDr.VoltHighly appreciated: "Atrial fibrillation is a progressive disease, and timely intervention is crucial for disease control and ultimately improving patients' quality of life. When I perform cardiac ablation, I look for a tool that offers excellent patient safety and can simplify the treatment of atrial fibrillation."VoltThe ablation system is a promising option for patients. Its real-time contact visualization feature and unique balloon basket design can provide better tissue contact and more precise energy delivery, while overcoming some of the limitations of earlier pulsed field ablation systems.

PFA(Pulsed Field Ablation) The market is in a phase of rapid development, with both the global and Chinese markets showing enormous growth potential. However, it also faces multiple challenges such as technological iteration, market competition, and expansion of indications. According to the latest data from a U.S.-based authoritative institution,2025Global Pulsed Electric Field Ablation (PFA) The market size has broken through55Billion USD, compared to2024Annual Growth35%, becoming the fastest-growing technical direction in the field of cardiac electrophysiology.

Multinational companies such as Boston Scientific, Medtronic, and Johnson & Johnson have actively laid out their strategies.PFAThe market is progressing smoothly with product commercialization, and the number of industry surgeries is growing rapidly. Boston Scientific'sFarapulseThe system is the most widely used globally and has the most clinical evidence-based medical evidence.PFAProduct,2024Annual sales breakthrough10Billion dollars. Medtronic'sPulseSelectThe system is the world's first to simultaneously receiveCE、FDA, Japan Regulatory andNMPAApprovedPFAProduct.

This approval marks Abbott's official entry into the U.S. market.PFAMarket, will cooperate with Medtronic, Boston Scientific, Johnson & Johnson Medical Technologies andKardiumCompanies such as Medtronic and Abbott Diagnostics Medical Co., Ltd. are engaged in fierce competition. Previously,VoltObtained earlier this yearCECertification, taking a solid step forward in its global market layout.

Affected by this news,BTIGAnalystMarie Thibault、Sam EiberAndAlexandra PangMaintain a "Buy" rating for Abbott.Analysts pointed out that this approval was slightly earlier than expected, as they had previously anticipated it would happen2026The first half of the year received approval. They noted that doctorsVoltPositive feedback, and look forward to supporting this approval.VOLT - AF IDEMore results of the study, which may be released in2026Year'sAFSOrHRSAnnounced at the meeting.

The analyst wrote in the report:"We10Doctor Survey in [Month] Shows,2026YearPFAThe market share will change significantly, asVoltAbout to enter the U.S. market, we expect the competitive landscape to become even more intense. We remain optimistic.PFA, and believeVolt"Obtaining U.S. approval will help promote the wider application of this technology category."

Abbott said it plans to launch in the United States soon.VoltCommercializationPFA(Case of Persistent Atrial Fibrillation) Treatment and Continued Expansion into the European Market. WithVoltWith the gradual promotion in the global market, it is expected to bring new treatment hope to more patients with atrial fibrillation, and will also promote technological innovation and development in the entire atrial fibrillation treatment field. In the future, competition in the atrial fibrillation treatment market will become increasingly intense.Instrument Family will Focus onThe competition among companies in terms of technology and market share.