Dive Brief:
- Johnson & Johnson said Tuesday it is introducing the Varipulse Pro pulsed field ablation device in Europe, where it has received CE mark approval.
- The atrial fibrillation treatment has a lower temperature profile compared to the current version of Varipulse and competitive devices, J&J said. Ablation is five times faster than the previous Varipulse sequence, while achieving equivalent lesions, according to the company. The new pulse sequence is designed to streamline procedures and improve workflow efficiency.
- The improvements reflect the company’s commitment to applying real-world learning and continuous innovation to advance its PFA platforms, J&J said.
Dive Insight:
J&J’s Varipulse device competes with Boston Scientific’s Farapulse and Medtronic’s PulseSelect PFA systems for treating atrial fibrillation, or AFib, a common form of irregular heartbeat that can lead to inefficient blood pumping.
PFA is becoming the preferred ablation technique to treat AFib for its safety and effectiveness and reduced procedure times. In a PFA procedure, electrical energy is used to destroy the tissue causing the irregular heartbeats.
Amid the intense competition, J&J has prioritized growth in its electrophysiology business, with executives committing to releasing a new PFA catheter every year through the end of the decade.
Varipulse Pro, which is not approved in the U.S., integrates with the company’s Carto 3 heart mapping system to support delivery of precise lesions. J&J said initial cases were performed in the VARIPURE multicenter, prospective postmarket follow-up study, and additional clinical studies are planned.
The company will showcase Varipulse Pro at the upcoming European Heart Rhythm Association annual meeting in Paris with live case demonstrations and training sessions. Twelve-month interim results from the VARIPURE study also will be presented at the meeting.
