Source of the article: Heart Future; Editor: Xiong Xiaoke
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Recently,Under Johnson & JohnsonBiosense WebsterAnnouncing itsFirst PFA Product——VaRipulse Pulse Field Ablation (PFA) Receives CE Approval for Market Launch, becoming the next after Medtronic and Boston Scientific,The Third PFA Product Approved by CE。
Varipulse Pulse Field Ablation (PFA)Used for treatmentSymptomatic Drug-Resistant Recurrent Paroxysmal Atrial Fibrillation. This follows the launch in Japan in January 2024,Another Milestone for Johnson & Johnson in the PFA Field. This CE approval also allows Johnson & Johnson to keep up with Medtronic and Boston Scientific.Expected to become the third company with PFA technology to receive FDA approval for the treatment of atrial fibrillation。
# Varipulse Pulse AblationVaripulse Composed of the Varipulse ablation catheter and TruPulse generator, it is also compatible with the Carto 3 cardiac 3D mapping system.Varipulse Ablation Catheter isDeveloped based on the previous Johnson & Johnson's Lasso catheter., which is the continuation of the Lasso catheter technology.The ablation catheter has 10 electrodes on its circular tip, with an adjustable circular tip size (ranging from 25 to 35mm). The catheter can be bidirectionally deflected, with one side deflecting 180° and the other side 90°, making it suitable for use in all four pulmonary veins, including the right inferior pulmonary vein.The TruPulse generator is a device used for cardiac ablation therapy.In the treatment of cardiac arrhythmiasProvide reliable power transmission and control, in order to achieve precise ablation effects。This generator is typically used in conjunction with other ablation devices and catheters forGenerate Pulse Fields Inside the Heart, to perform precise ablation treatment on cardiac tissue.It hasHighly precise energy control and regulation function, which can be customized according to the doctor's needs, thereby improving treatment efficacy and safety.Carto 3 Utilizing advanced3D Imaging Technology, which can be used to perform real-time procedures on the patient's heart in the operating room.High-resolution mapping。It can accuratelyLocating Abnormal Electrical Activity in the Heart, and provide doctors with visual navigation and positioning information to guide cardiac ablation treatment.# Data from Two Clinical StudiesInspIRE(EvaluationVaripulse Safety and Efficacy of Treatment for Drug-Resistant Paroxysmal Atrial Fibrillation, Study Locations: Europe and Canada- At 12 months postoperatively,About75.6%The patient reached the primary clinical endpoint.(i.e., no recurrence of atrial arrhythmia), Johnson & Johnson stated that 80% of participants who received optimal PFA application reached the primary effectiveness endpoint.
- Fluoroscopy time was relatively low, at 7.8 minutes.。
- Safety results showed a primary adverse event rate of 0.。
admIRE(EvaluationVaripulse Safety and Efficacy of Treatment for Drug-Resistant Paroxysmal Atrial Fibrillation, Study Location: United States (Data Disclosed for the First 20 Patients Only)- 100% of patientsAcute success was achieved through ablation.。
- 80% of patientsNo recurrence of atrial arrhythmia within one year。
- NoReportMajor Adverse Events Related to Surgery or Instruments。
- The median operation time and fluoroscopy time were respectively90.0 minutes and 3.5 minutes。
# The Global Giants' Competition in PFA
In the global medical device market,Cardiovascular is the second largest medical device market, second only to IVD. In all细分fields of cardiovascular,Electrophysiology with Continuous High Growth for Over 20 YearsKnown as the "favorite" of cardiovascular giants.
In 1998, Biosense Webster, a subsidiary acquired by Johnson & Johnson for $400 million, was launched.The World's First Cardiac Electrophysiology Radiofrequency Catheter Ablation Product，Pioneered a new branch in the field of electrophysiology — Ablation。As an incremental market, the emergence of ablation has laid the foundation for over 20 years of high growth in the electrophysiology field.Ablation Field Rapidly Becomes Battleground for Cardiovascular Giants。So far, Johnson & Johnson, Boston Scientific, Abbott, and Medtronic have occupied a globally leading position in the cardiac ablation field.Over the past two decades, radiofrequency and cryoablation have become the mainstream in the field of ablation.However, both types of energy are non-selective in terms of tissue targeting, potentially causing damage to adjacent organs such as the esophagus, phrenic nerve, or lungs. The risk of certain complications, the risk of atrial fibrillation recurrence due to insufficient ablation, and a steep learning curve have led to...The industry is eagerly anticipating a safer and more efficient ablation technology.。PFA is regarded as "the leading technology in cardiac ablation for the next decade" because it meets the aforementioned expectations.FMI data shows，From 2021 to 2022, the global pulsed field ablation market experienced a compound annual growth rate of 48.6%, reachingThe market size reached 1.3 million US dollars in 2023.。According to historical data, the market has been steadily growing with the adoption of modern technologies such as robot-assisted surgery and the reduction of invasive surgical techniques.Boston Scientific previously estimatedPFA Will Dominate the Atrial Fibrillation Treatment Market in the Next Five Years, making an early layout here.
▲Characteristics of PFA:Pulmonary thermal effect andTissue Selectivity
At present, several giants are striving to break the deadlock, respectivelyObtain approval or clinical progress for PFA products：- December 2023,MedtronicPulseSelect Pulsed Field Ablation System Receives FDA Approval, BecomingThe First Pulsed Field Ablation Technology to Receive FDA ApprovalIn November, PulseSelect PFA obtained the CE mark.
- In the same month, domestically produced PFA also made a breakthrough.Jinjiang Electronics"Single-use Cardiac Pulsed Field Ablation Catheter PulsedFA" and "Cardiac Pulsed Field Ablation System LEAD PFA" Innovative Products Officially Receive NMPA ApprovalThe First Approved Cardiac PFA Product in China。
- Subsequently,Boston ScientificPulsed Electric Field Ablation DeviceFarapulseReceived FDA Approval in January 2024; At the beginning of 2021, the Farapulse PFA System received CE approval for marketing.
Johnson & Johnson's Pulsed Electric Field Ablation Device Varipulse Obtained in January 2024Approved for marketing by Japan's Ministry of Health, Labour and Welfare (MHLW), indicated for the treatment of symptomatic drug-refractory recurrent paroxysmal atrial fibrillation. This isJapan's First Approved PFA Product。CompanyPlan to submit FDA application in 2024.A complete PFA system mainly consists of three parts: the energy unit (generator/device) + ablation catheter + mapping platform. Currently, all manufacturers’ products are used as matched sets.
▲Pulsed Field Ablation (PFA) Product
# The PFA Market in China is BroadCurrently, the potential of China's cardiac electrophysiology market is enormous: on one hand,The penetration rate of electrophysiology procedures is less than 1%., with tremendous room for development; on the other hand,Market share of Chinese brands is less than 10%., withHuge Space for Domestic Substitution。The potential of the Chinese market has triggered a surge of competitors in the pulsed electric field ablation market both domestically and internationally.Jinjiang Electronics, founded in 2002, takes the lead and has gone public.China's First PFA Cardiac Electrophysiology Product, including the LEAD-PFA Cardiac Pulsed Field Ablation System and the Pulsed FA Single-Use Cardiac Pulsed Field Ablation Catheter, characterized by magnetic navigation and integrating 3D modeling, mapping, and ablation.The market launch time is almost simultaneous with the FDA approval of Medtronic's PFA product. This was made possible by the collaboration with Bard (acquired by BD Medical) in 2004 in the field of radiofrequency ablation devices, as well as the acquisition of Cardima in 2011, which brought advanced electrophysiology interventional technology.Jinjiang Electronics PFA Clinical Trial Results Show Zero Complications in 151 Enrolled PatientsNotably, the PFA products of Medtronic, Johnson & Johnson, and Boston Scientific have all entered the NMPA Innovative Medical Device Special Review Process, and they are currently competing for the "first foreign enterprise to launch a PFA product in China."At least 50 companies in China are currently developing PFA cardiac ablation systems., PFA products from Denova (formerly Nuomao Medical), a domestic device company, and Beixing Medical have also entered the NMPA special review process. Companies such as Huitai Medical, Xuanyu Medical, Aikema Medical, Maiwei Medical, Xinlvtong, Zhoulǐng Medical, Yuanshan Medical, and Xinhanglu Medicine are also actively deploying PFA.For a blue ocean track that is starting commercial landing, with the approval of many manufacturers' PFA products, how to break through in the transition from blue ocean to red ocean has become extremely critical.
Biosense Webster is a company formed by Johnson & Johnson in 1996 after acquiring Cordis Webster for $1.8 billion and Biosense for $400 million.Specializing in Johnson & Johnson's electrophysiology business, dedicated to the research and development of electrophysiology interventional diagnosis and treatment products., providing a comprehensive solution for arrhythmia diseases to physicians and patients across the country. At that time, Cordis Webster's core products, catheters and angioplasty balloons, helped further enrich Johnson & Johnson's cardiac stent product line. Biosense, with its excellent and innovative technology, is a global leader in 3D mapping systems and software. It is also the inventor of the world’s first deflectable catheter.
The company's products are divided into six categories:3D Navigation System, Diagnostic Catheter, Therapeutic Catheter, Ultrasound Equipment, Interventional Devices, Generator。
# Global Leading Cardiovascular Device CompanyEdwards Lifesciences | AbbottAbbott｜
# Cardiovascular Device Companies Listed in China
# Innovative Medical Devices Approved in China in 2023#2023 Medical Devices Entering China's Innovation PathwayXinQing Medical (NyokAssist Interventional Ventricular Assist System)
Beixins Life (Cardiac Pulse Field Ablation)
Hanling Medical (Transcatheter Aortic Valve)
# Other Unlisted/Start-up Cardiovascular Companies
Artivion| HVR Cardio | CardiacSense | Lydus Medical | Volta Medical |Cardiac Dimensions
