Johnson & Johnson's VARIPULSE PFA Platform Receives FDA Approval for Irrigation Flow Rate Enhancement

Johnson & Johnson announces FDA approval of itsVARIPULSETheIrrigation FlowUpgrade Solution. This technological upgrade reflects Johnson & Johnson's commitment to advancing PFA technology innovation based on real-world clinical practice.

Executive Evaluation

"By drawing on real clinical experience and collaborating closely with medical experts, we continuously optimize our technology to enhance patient care. The upgrade of the VARIPULSE platform demonstrates our unwavering commitment to lead the development of PFA technology through meaningful, data-driven improvements, thereby enhancing product performance and procedural confidence."

---Michael Bodner  Global President of Electrophysiology and Neurointervention, Johnson & Johnson Medical Technology

Last yearVARIPULSEFirst FDA approval for marketing, currentlyVARIPULSE has been in the United States,Over 10,000 surgeries have been completed in regions such as Europe, Canada, Japan, Hong Kong, China, mainland China, South Korea, Taiwan, China, and Australia.VARIPULSE has completed over 10,000 surgeries in about a year since its market launch, demonstrating Johnson & Johnson's commercial capabilities.

Of course, Johnson & Johnson faced challenges at the beginning of the year.Neurovascular adverse events, which have worried doctors and patients. This time, Johnson & Johnson alsoJohnson & Johnson Discloses Response to Incidence of Neurovascular Adverse EventsVARIPULSENeurovascular Adverse EventsIncidence RateAlways keep it below 0.5%.

Recently, Johnson & Johnson has made a series of advancements in the PFA field, aside from the FDA approval of this new technology. Earlier this month, the companyLaunch in the Asia-Pacific RegionVARIPULSEAblation Platform, and AppointmentNewChief Medical Science Officer. These advancements will rapidly propel Johnson & Johnson's layout in the PFA field. Combined with Johnson & Johnson's strong foundation in electrophysiology, it will accelerate the pace to catch up with Boston Scientific and Medtronic, significantly increasing the chances of surpassing them in the future.

VARIPULSEThe ablation catheter was developed after Johnson & Johnson's previous mapping catheter, the LASSO catheter.Continuation of LASSO Catheter Technology. This also demonstrates Johnson & Johnson's capabilities in the catheter fieldProfound Technical Reserve。

VARIPULSEThe ablation catheter has 10 electrodes on its circular tip, and the size of the circular tip is adjustable (from 25 to 35mm). MeanwhileVARIPULSEThe ablation catheter can be bidirectionally deflected, with one side deflecting 180° and the other side 90°, making it suitable for all four pulmonary veins, including the right inferior pulmonary vein. PFA is applied in a bipolar configuration between skipped electrodes (i.e., electrode 1 to electrode 3) as well as between each pair of adjacent electrodes (i.e., electrode 1-2 and 2-3) at an energy level of 1800 V. Each PFA application consists of a sequence of microsecond-long biphasic pulses delivered across all three bipolar configurations, with a total application duration of approximately 250 milliseconds.

Johnson & Johnson has always been committed to addressing the most complex health challenges globally. For a century, we have driven the advancement of surgical care through innovative products such as wound closure, hemostatic assistance, surgical stapling devices, robotics, and digital solutions. Collaborating with clinical experts worldwide, we continue to revolutionize surgical techniques to better meet patient needs in metabolic diseases, cardiovascular diseases, oncology, and plastic reconstruction.