The U.S. Food and Drug Administration (FDA) has granted approval to Johnson & Johnson MedTech for its Varipulse device, designed to treat a specific heart condition that causes abnormal rhythms. This announcement was made on November 7, 2024.
The Varipulse system is a pulsed field ablation (PFA) platform aimed at addressing drug-refractory paroxysmal atrial fibrillation (AFib). This condition is characterized by intermittent episodes of irregular heartbeats that can last from a few minutes to several hours. The approval positions Johnson & Johnson alongside other medical device manufacturers, such as Boston Scientific and Medtronic, which also offer devices for treating atrial fibrillation.
The FDA’s decision was informed by the results of the admIRE clinical trial, which involved 277 patients across various U.S. centers. The trial demonstrated that the Varipulse system achieved acute procedural success in all patients, with a primary effectiveness rate of 75%.
Notably, adverse events were reported in only 2.9% of participants, and nearly half were able to return home on the same day as their treatment.
The Varipulse platform is unique as it integrates seamlessly with the Carto 3 electroanatomical mapping system, allowing electrophysiologists to visualize the heart in real-time during procedures. This integration is expected to enhance the efficiency and accuracy of AFib treatments.
Jasmina Brooks, president of electrophysiology at Johnson & Johnson MedTech, expressed enthusiasm about the approval.
She highlighted that the Varipulse platform is tailored for effective AFib procedures and will significantly benefit both physicians and patients in the U.S., where nearly eight million individuals are affected by this condition.
This approval marks an important milestone for Johnson & Johnson MedTech as it expands its offerings in the growing market for atrial fibrillation treatments. The Varipulse system joins other recently approved PFA devices from competitors, including Boston Scientific’s Farapulse and Medtronic’s PulseSelect systems.
In summary, the FDA’s approval of Johnson & Johnson’s Varipulse device represents a significant advancement in the treatment of atrial fibrillation, providing healthcare professionals with a powerful tool to improve patient outcomes in this common heart rhythm disorder.
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