Enrollment completed ahead of schedule in the global IDE for Abbott's Volt™ PFA SystemGlobal FOCALFLEX trial now underway for Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, receives U.S. Food and Drug Administration clearance, begins commercial launchABBOTT PARK, Ill., Oct.

雅培Volt™PFA SystemGlobal FOCALFLEX试验的全球IDE提前完成注册，目前正在进行雅培TactiFlex™Duo消融导管，Sensor Enabled™Advisor™HD Grid X Mapping导管，Sensor Enabled™的全球FOCALFLEX试验，获得美国食品和药物管理局的批准，10月10日开始商业启动伊利诺伊州雅培公园。

10, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) announced today it has achieved new major milestones to support the company's growing suite of pulsed field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE Study supporting the Volt™ PFA System, and the launch of the FOCALFLEX trial to assess the company's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (SE), which will be used in the treatment of patients with paroxysmal atrial fibrillation.

102024/PRNewswire/--雅培（纽约证券交易所：ABT）今天宣布，它已经取得了新的重大里程碑，以支持该公司在电生理学领域不断增长的脉冲场消融（PFA）解决方案：尽早完成支持VOLT™PFA系统的VOLT-AF IDE研究的注册，并启动FOCALFLEX试验，以评估该公司的TactiFlex™Duo消融导管Sensor Enabled™（SE），该导管将用于治疗阵发性心房颤动患者。

Together, these two studies represent significant advances for the future of two Abbott PFA catheters, which are being developed as important tools for physicians treating people with abnormal heart rhythms like atrial fibrillation (AFib)..

总之，这两项研究代表了两种雅培PFA导管未来的重大进展，这两种导管正被开发为医生治疗异常心律（如心房颤动（AFib））患者的重要工具。。

In addition, Abbott also announced U.S. Food and Drug Administration (FDA) clearance of the company's Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, which will further support mapping of both PFA and radiofrequency (RF) ablation cases, where visualization of cardiac anatomy is critical to ensure the best outcomes for people undergoing ablation procedures..

此外，雅培还宣布美国食品和药物管理局（FDA）批准该公司的Advisor™HD Grid X映射导管Sensor Enabled™，该导管将进一步支持PFA和射频（RF）消融病例的映射，其中心脏解剖结构的可视化对于确保接受消融手术的人取得最佳结果至关重要。。

'It was exciting to participate in the VOLT-AF IDE Study to help assess a next-generation PFA catheter that incorporates new design concepts we believe will advance PFA technology and improve patient outcomes,' said Monica Lo, M.D., an electrophysiologist with Arkansas Heart Hospital who specializes in complex arrhythmias.

阿肯色州心脏医院专门研究复杂心律失常的电生理学家莫妮卡·洛（MonicaLo）医学博士说：“参加VOLT-AF IDE研究以帮助评估下一代PFA导管令人兴奋，该导管结合了我们认为将推进PFA技术并改善患者预后的新设计概念。”。

'Only through studies like VOLT-AF and Abbott's new FOCALFLEX trial, can we fully understand and safely deploy the next generation of AFib treatments to help people enjoy life free from complex heart rhythm conditions.'.

“只有通过VOLT-AF和Abbott的新FOCALFLEX试验等研究，我们才能充分了解并安全部署下一代AFib治疗方法，帮助人们享受没有复杂心律条件的生活。”。

New Advancement in Pulsed Field Ablation, Treating AFibHistorically, patients requiring a cardiac ablation procedure to treat conditions like AFib received RF ablation, which uses heat to destroy tissue responsible for erratic heart signals, or cryogenic ablation, which freezes tissue. Instead of heat or extreme cold, PFA uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy..

脉冲场消融治疗AFib的新进展历史上，需要心脏消融程序治疗AFib等疾病的患者接受射频消融，射频消融利用热量破坏导致心脏信号不稳定的组织，或低温消融，使组织冻结。PFA不使用高温或极冷，而是使用高能电脉冲破坏引起异常心律的细胞，这可以降低患有复杂疾病或解剖结构的患者破坏邻近组织的风险。。

PFA represents a promising opportunity to treat people with abnormal heart rhythms with new technology that may offer safety advantages* that can reduce known risks of traditional ablation therapies. However, existing early-generation PFA systems have limitations, including the lack of three-dimensional visualization and coupling with a 3D cardiac mapping system*.

PFA代表了一个很有希望的机会，可以用新技术治疗心律异常的患者，这种新技术可能提供安全优势*可以降低传统消融疗法的已知风险。然而，现有的早期PFA系统存在局限性，包括缺乏三维可视化以及与3D心脏映射系统的耦合*。

Other limitations that Abbott's PFA systems were designed to address include no indication of catheter-tissue contact and repeat ablations to ensure favorable patient outcomes*. Increased interest in Abbott's PFA system propelled enrollment in the U.S. VOLT-AF IDE Study to be completed four months ahead of the anticipated timeline, enrolling almost 400 patients in just three months..

雅培PFA系统旨在解决的其他局限性包括没有导管组织接触的迹象和重复消融以确保有利的患者结果*。对雅培PFA系统的兴趣增加，推动了美国VOLT-AF IDE研究的注册工作提前四个月完成，仅三个月就招募了近400名患者。。

Abbott's investigational Volt PFA System was designed to overcome prior limitations in PFA systems by pairing a balloon-in-basket catheter with Abbott's EnSite™ X EP System, an industry-leading heart mapping solution. The unique basket shape of the catheter's energy delivery area paired with the balloon are designed to effectively transfer Abbott's optimized waveform energy to the tissue by ensuring better catheter contact and stability during the procedure*.

雅培的研究性Volt PFA系统旨在通过将球囊篮式导管与雅培的EnSite™X EP系统（一种业界领先的心脏标测解决方案）配对来克服PFA系统的先前局限性。与球囊配对的导管能量输送区域的独特篮形旨在通过确保手术过程中更好的导管接触和稳定性，有效地将雅培优化的波形能量转移到组织*。

Another unique feature of Abbott's PFA catheter is how the platform's PFA generator and the EnSite X EP System are designed to give physicians the ability to specifically target lesions and ablate the exact area(s) of the heart that are triggering arrhythmia..

。。

In addition to the VOLT-AF IDE Study, Abbott's global FOCALFLEX Pulsed Field Ablation Study is also now underway to assess the company's TactiFlex Duo Ablation Catheter, Sensor Enabled. This catheter is designed as a dual-energy ablation solution offering both PFA and RF energy delivery, and will also be assessed in the FLEXPULSE IDE, which is expected to launch in the U.S.

除了VOLT-AF IDE研究之外，雅培的全球FOCALFLEX脉冲场消融研究也正在进行中，以评估该公司的TactiFlex Duo消融导管，该导管具有传感器功能。该导管设计为双能量消融解决方案，可同时提供PFA和RF能量输送，也将在FLEXPULSE IDE中进行评估，预计将在美国推出。

soon, with about 200 patients at 25 sites..

很快，在25个地点约有200名患者。。

Where the Volt PFA System is designed as a 'single shot' PFA approach, the TactiFlex Duo Ablation Catheter, SE is a 'focal' or 'point-by-point' approach that aims to deliver the safety and efficiency of PFA with more flexible and focused energy. Designed on Abbott's TactiFlex Ablation Catheter, Sensor Enabled, known for its stability during procedures due to its novel flexible tip, the TactiFlex Duo Ablation Catheter, SE aims to offer physicians another option for delivering PFA and/or RF to patients with greater versatility to precisely target specific areas of tissue within the heart..

。。

'There's immense value in exploring different therapy options for patients to treat abnormal heart rhythms because each case is unique,' said professor Prash Sanders, M.B.B.S., Ph.D., director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures with the TactiFlex Duo Ablation Catheter, Sensor Enabled for the FOCALFLEX trial.

澳大利亚阿德莱德大学心律失常中心主任、医学博士Prash Sanders教授说：“为患者探索不同的治疗方案来治疗异常心律具有巨大的价值，因为每种情况都是独特的。”他使用TactiFlex Duo消融导管进行了第一次手术，该导管为FOCALFLEX试验启用了传感器。

'Abbott improved upon limitations of first-generation systems and has successfully advanced its approach to PFA beyond those initial systems that have come to market.'.

“雅培改进了第一代系统的局限性，并成功地将其PFA方法推广到了已经上市的初始系统之外。”。

Abbott's Advanced Cardiac Mapping Solutions Support Improved OutcomesAs ablation innovations evolve, a key element of effective treatment continues to be the use of heart mapping. Accurate mapping for RF procedures has been critical in electrophysiology, and the adoption of mapping for PFA procedures continues to grow.

雅培的先进心脏标测解决方案支持改善结果随着消融创新的发展，有效治疗的关键因素仍然是使用心脏标测。射频程序的准确映射在电生理学中至关重要，而PFA程序映射的采用仍在继续增长。

Abbott has seen increased reliance on its mapping technology as more physicians begin to explore the use of PFA for patients..

随着越来越多的医生开始探索PFA在患者中的应用，雅培越来越依赖其绘图技术。。

With its recent FDA clearance, the Abbott Advisor HD Grid X Mapping Catheter, Sensor Enabled, offers a first-of-its-kind electrode configuration for high-density heart mapping. This design is intended to make physicians more aware of electrical signals of the heart, regardless of catheter placement during an ablation procedure..

随着最近FDA的批准，雅培顾问HD Grid X标测导管（传感器启用）为高密度心脏标测提供了首创的电极配置。这种设计旨在使医生更了解心脏的电信号，无论消融过程中导管的放置如何。。

For U.S. important safety information go to:TactiFlex™ Ablation Catheter, Sensor Enabled™https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/tactiflex-se-ablation-catheter/indications-safety-warnings.html

有关美国重要安全信息，请访问：TactiFlex™消融导管，传感器启用™https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/tactiflex-se-ablation-catheter/indications-safety-warnings.html

Advisor™ HD Grid Mapping Catheter, Sensor Enabled™https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/diagnostic-catheters/advisor-hd-grid/about.html

Advisor™HD网格映射导管，传感器启用™https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/diagnostic-catheters/advisor-hd-grid/about.html

EnSite™ X EP Systemhttps://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html

EnSite™X EP Systemhttps://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html

Investigational/Under-Development Products*Devices or products referenced are INVESTIGATIONAL and/or UNDER DEVELOPMENT. Product specifications or proposed intended uses are design goals and subject to change.

研究/正在开发的产品*引用的设备或产品是研究和/或正在开发的。产品规格或拟议的预期用途是设计目标，可能会发生变化。

About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries..

AbbottAbbott是一家全球医疗保健领导者，致力于帮助人们在生命的各个阶段都生活得更加充实。我们的生命改变技术组合涵盖了医疗保健领域，拥有诊断、医疗器械、营养品和品牌仿制药领域的领先业务和产品。我们的114000名同事为160多个国家的人民服务。。

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

请通过www.abbott.com、LinkedIn（www.LinkedIn.com/company/abbott-/）、Facebook（www.Facebook.com/abbott）和Twitter@AbbottNews与我们联系。

SOURCE Abbott

来源：雅培