Source of the article:Heart NotCome;Editor:Liu XinyiReprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.On January 19, 2024, Abbott (NYSE: ABT) announced that its subsidiaryNovel Volt™ Pulsed Field Ablation (PFA) SystemFirst applied to the human body, the first surgeries have been performed globally toTreating patients with arrhythmias such as atrial fibrillationPatients.▲ Volt PFA system（Source(From the company's official website)This batch of surgeries is part of Abbott's research to obtain CE certification for the Volt™ system. The study is a pre-market, multi-center clinical trial that has recently treated more than 30 patients in Australia, and future procedures will expand to the Asia-Pacific and European regions. Additionally, Abbott anticipates that further developments regarding the Volt™ system will occur in the first half of this year.IDE (Investigational Device Exemption) clinical trial applications will receive FDA approval.。# Volt™ Pulsed Electric Field Ablation SystemThe Volt™ of this ablation systemCatheter appearsBasket-like, the basket has 8 branches and belongs to a bipolar catheter,With an expansion balloon inside, which can effectively transmit energy to the tissue. Previously, Abbott's PFA catheter was circular, requiring multiple ablations at different positions during treatment, which received poor market feedback. As a result, the second-generation PFA catheter underwent design improvements.▲ SourceFrom the company's official websiteIn addition, this ablation system integrates Abbott's advanced mapping system.EnSite™ X EP(Similar to Johnson & Johnson, emphasizing the advanced mapping system). This mapping system received CE certification in November 2020 and FDA approval in January 2022. The system features are as follows:▲ EnSite X EP System（Source(From the company's official website)Two Modes：The FirstMapping System with Two Types of Cardiac Visualization Methods，Combines single-level measurement and bipolar measurementSingle-pole measurement has advantages in direction and speed, while bipolar measurement can provide localized signal measurement to locate the target area;360° Sampling: Capable of 360° sampling of EGM, can map 1 million points of the heart;Equipped with OT Technology: The full name of OT technology is Omnipolar Technology, a new method that calculates bipolar electrograms independent of the catheter's wavefront direction. It provides real-time beat-by-beat visualization of activation direction and 360-degree computed maximum voltage for precise high-density mapping.Magnetic Control Technology: The use of magnetic control technology can help doctors manipulate catheters more precisely;3D Image Reconstruction Technology: The system can generate high-precision 3D images by collecting electrical signals and position information of the heart;Multifunctionality: This system can not only be used for the diagnosis and treatment of heart diseases, but also for operations such as the implantation and adjustment of pacemakers;Highly Extensible:The software inside the system can be upgraded, allowing access to the latest technology without replacing the device.# The Multifaceted Challenges in the PFA MarketAbbott's electrophysiology business is valued at $1.9 billion. Currently, itsDevelopment of Pulsed Electric Field Ablation TechnologyCurrently lagging behind three major rivals:Medtronic(PulseSelect System and Affera System),Boston Scientific(FARAPULSE System) andJohnson & Johnson(Varipulse System).Medtronic's PulseSelect isThe First Product Approved by the FDAThe PFA system, which is gaining momentum in the U.S. market. In addition, Medtronic has acquired Affera; Boston Scientific's FARAPULSE.First to receive CE approval, which has already taken root in the European market; Johnson & Johnson's Varipulse has also been approved in Japan and is about to break through in new regions.
Up: PulseSelect, FARAPULSE, Affera
PulseSelect System andFARAPULSESystemNone used mapping systems., while most cryoballoon ablations require the use of a mapping system.
If PFA replaces cryoballoon ablation, the use of Abbott's diagnostic catheters and mapping systems may decline.. Some analysts said,Diagnostic catheters and mapping systems account for approximately47%。
Moreover, in Abbott's electrophysiology business, radiofrequency ablation accounts for about 25%, and interventional (Access) devices account for approximately 18%. Analysts stated,Products accounting for approximately 90% of Abbott's electrophysiology sales may be affected by the market shift towards PFA.
And this Volt™ pulsed field ablation system may not be approved in the United States until 2027 or 2028.Loss of Abbott's Electrophysiology Market Share May Accelerate in 2025How Abbott will break the deadlock in the future remains to be seen.
Abbott, founded in 1888 and headquartered in Chicago, USA, has developed over a century into a diversified Fortune 500 company and an international healthcare company. Abbott's businesses are divided into four categories: pharmaceuticals, nutrition, diagnostics, and medical devices. Among them,Medical DeviceFurther divided intoHeart Rate Management、Electrophysiology、Heart Failure、Blood Vessel、Structural Heart、NeuromodulationAndDiabetesSubclasses such as。On October 18, 2023, Abbott announced its financial results for the third quarter of fiscal year 2023. The earnings report showed that Abbott's total revenue in the third quarter reached 10.1 billion US dollars, of whichSales of medical devices increased by 16.6% year-on-year.. The growth in medical device sales is mainly driven byElectrophysiology, Structural Heart, Neuromodulation, and DiabetesDriven by double-digit organic growth.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
