CANADA – Johnson & Johnson MedTech has achieved a major milestone in the treatment of atrial fibrillation (AFib) in Canada.
The company recently announced the completion of the first commercial case using its innovative Varipulse platform, performed at the Ottawa Heart Institute.
This marks a significant step forward in managing AFib, utilizing the advanced pulsed field ablation (PFA) technology.
The Varipulse system represents a cutting-edge approach to treating AFib. It features the Varipulse catheter, a variable-loop multielectrode device designed to isolate the pulmonary veins.
The system also includes the TruPulse generator and the Carto 3D cardiac mapping system, which work together to offer a seamless, reproducible workflow with real-time visualization and feedback.
This integration enables more precise, effective procedures for cardiac arrhythmia management.
“We’re excited to bring this groundbreaking treatment to Canada,” the company wrote, expressing gratitude to the Ottawa Heart Institute for their partnership in advancing cardiac care.
Johnson & Johnson MedTech emphasized its commitment to helping patients live better lives through innovative medical technologies.
Pulmonary vein isolation with enhanced versatility
Varipulse offers several key features that set it apart from other PFA technologies.
Its versatile catheter loop, user-friendly generator interface, and intuitive mapping system simplify the procedure for physicians, while contact indicators and pulsed field tagging mechanisms enhance the precision of the ablation process.
This system allows doctors to more accurately target and treat the areas of the heart causing AFib, improving patient outcomes.
FDA approval on the horizon
Johnson & Johnson MedTech is also aiming to bring Varipulse to the U.S. market. The company submitted the system for FDA approval in March 2024.
If authorized, Varipulse would become the third PFA technology approved for AFib treatment in the U.S., following similar systems by Medtronic and Boston Scientific.
J&J’s Varipulse system has already shown promise in clinical trials. The Inspire study, conducted in Canada and Europe, enrolled 272 participants with paroxysmal AFib.
After 12 months, more than 75% of patients remained free from atrial arrhythmia recurrence, with the figure rising to 80% among those receiving optimal levels of PFA application.
Comparing performance with competitors
The Inspire trial results have outperformed pivotal studies from other leading PFA systems. Boston Scientific reported 73% of patients were free from AFib recurrence after 12 months, while Medtronic’s trial showed just over 66% of patients achieving the same outcome.
However, analysts caution that cross-study comparisons can be misleading due to differences in trial designs and patient populations.
Notably, J&J’s trial participants were younger, with an average age of 59 years compared to 62 and 63 years in Boston Scientific’s and Medtronic’s studies, respectively.
Expanding AFib market and future prospects
With the successful launch of Varipulse in Canada, Johnson & Johnson is positioning itself to compete in the growing AFib market, which RBC Capital Markets analysts predict will reach US $5.8 billion by 2026.
Analysts anticipate a “rapid shift to PFA” as the preferred treatment for AFib, although concerns about the higher cost of PFA compared to traditional radiofrequency ablation could slow its adoption.
Physicians have noted that PFA procedures currently cost twice as much as radiofrequency ablation in Europe.
However, they expect pricing to decrease as PFA technology becomes more widely used. Additionally, integrating ablation and mapping capabilities into a single catheter, as J&J has done with Varipulse, may help lower overall treatment costs by reducing the need for multiple catheters.
