Dive Brief:
- Johnson & Johnson said Thursday it has received Europe’s CE mark for its Varipulse pulsed field ablation (PFA) device to treat atrial fibrillation (AFib), a common form of irregular heartbeat that can increase stroke risk.
- The approval positions J&J to take on Medtronic and Boston Scientific in a market share battle for a promising new technology to treat the heart rhythm disorder, in which the upper and lower chambers beat out of sync. The Varipulse device also recently gained approval in Japan.
- J&J said the safety and effectiveness of its platform was studied in the Inspire clinical trial that included 186 patients in Canada and Europe.
Dive Insight:
PFA, which uses electrical pulses to ablate the heart tissue causing the abnormal rhythm, has generated strong interest from physicians because of its potential to avoid complications associated with traditional thermal energy-based ablation.
The catheter-based treatment can selectively ablate the tissue to reduce the risk of damage to surrounding structures such as the esophagus and pulmonary vein.
PFA systems from Medtronic and Boston Scientific that are already in use in Europe have received positive feedback, according to those companies. Both Medtronic and Boston Scientific have also recently gained Food and Drug Administration approval to launch their PFA devices in the U.S.
J&J said it presented one-year follow-up data from the Inspire trial this month at the AF Symposium in Boston that showed 80% of patients who received the optimal PFA treatment achieved freedom from recurrence without primary adverse events.
The study’s main effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence was 75.6%.
“Most importantly, the recent published data on the [Varipulse] Platform demonstrates the safety using pulsed field ablation for patients being treated for AF,” Tom De Potter, associate director of the Cardiovascular Center at OLV Hospital in Aalst, Belgium, said in a statement from J&J.
J&J has said it plans to submit the Varipulse catheter to the FDA for review this year.