Johnson & Johnson announces its new PFA productOmnypulseCompletion of Enrollment in Clinical Study (Omny-IRE). Omny-IRE is a prospective, multi-center, non-randomized clinical trial that enrolled 188 patients in Europe and Canada to evaluateOmnypulseSafety and Efficacy of Treating Symptomatic Paroxysmal Atrial Fibrillation."In the cases I conducted as part of the Omny IRE clinical study, the integrationThe Omnypulse platform enables me toCapable of drawing and transmitting pulse field energy in a seamless manner.Omnypulse"The contact force data of the catheter gives me confidence in tissue contact before ablation, and then calculates the PF index during energy delivery."---Mattias Duytchaever AZ Sint-Jan Hospital"It is exciting to play a role in advancing the PFA field through clinical studies like Omny IRE. Based on my experience in...OmnypulsePlatform"As part of my experience in the study, I found the PF index and contact force feedback to be very valuable in tailoring treatment decisions for patients during surgery."
---Johan Vijgen Jessa Hospital"With the full enrollment of the Omny IRE clinical study, we continue to make significant progress in advancing the collective knowledge and understanding of PFA."We hope to integrate theOmnypulsePlatformWill become an exciting new tool in Johnson & Johnson's advancing PFA solution multifunctional portfolio, providing electrophysiologists with a set of tools they need to deliver the best surgical outcomes for their patients.”---Jennifer Currin, Vice President of Scientific Affairs, Johnson & Johnson Cardiovascular and Professional SolutionsSince 2021, Boston ScientificSince Farapulse received CE approval for marketing, the entire electrophysiology market has entered the PFA era. Three years later,Medtronic, Johnson & Johnson, CardioFocus, Denovo EP and other enterprises in China and abroad have successively obtained approvals from regulatory authorities such as CE, FDA, and NMPA for market launch. As the current leader in the electrophysiology field, Johnson & Johnson is facing unprecedented competitive pressure. Boston Scientific and Medtronic are both eyeing to seize Johnson & Johnson's market share, while smaller PFA participants are also hoping to get their share.Fortunately, Johnson & Johnson has a strong foundation and quickly developed several P products in a short period of time.FA product. And let the first PFA---Varipulse has obtained CE approval and is also expected to receive FDA approval this year. This allows Johnson & Johnson to keep up with Boston Scientific and Medtronic, while leveraging its deep technical expertise in catheters and mapping to quickly launch the next generation of PFA products, fend off competitors, and maintain its leading market share in electrophysiology.OmnypulseIt is one of the next-generation PFA products that could help Johnson & Johnson regain market share.
OmnypulsePlatformByOmnypulseThe catheter and Johnson & Johnson's universal energy generator TRUPULSE are components, and they can be used in conjunction with the world's most advanced three-dimensional mapping system, CARTO 3.OmnypulseGuideThe catheter has a diameter of 7.5Fr and is a steerable ablation catheter. Its distal end features an expandable basket design, which can expand to 12mm.Distal end of the catheterThe net basket consists of six strips, each with two electrodes distributed on it.OmnypulseIn addition to a different design from traditional catheters, Johnson & Johnson has equipped the Omnypulse with two cutting-edge technologies. The first is tactile feedback, and the second is an enhanced mapping function (TRUEref).Strong mapping capabilities (TRUEref), previously Johnson & Johnson inMapping catheters OPTRELL and OCTARAY haveClose application,TRUEref allows the catheterWith higher precision and detailed map drawing capabilities, as well as improved signal quality.In additionOmnypulseWhen used with the TRUPULSE generator, the catheter can achieveOmnypulseThe catheter's twelve electrodes deliver bipolar, biphasic pulses. When used in conjunction with CARTO 3, it allows physicians to obtain the Pulse Field (PF) index value for each ablation, a calculation based on real-time contact force feedback combined with the number of pulse field applications.
Biosense Webster Biosense, a professional medical device company under Johnson & Johnson, is dedicated to the research and development of electrophysiological interventional diagnosis and treatment products, providing comprehensive solutions for arrhythmia diseases to physicians and patients. Biosense holds a leading position in the global market for 3D mapping systems and software with its excellent and innovative technology.It is also the inventor of the world's first curved catheter.
