Varipulse treats symptomatic drug-refractory recurrent paroxysmal AFib using pulsed field ablation (PFA). The platform features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system.
Biosense Webster says this marks the first and only PFA system approval in Japan.
According to a news release, Varipulse is the first and only Carto-integrated PFA system. It enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.
Biosense Webster’s inspIRE trial’s early clinical results demonstrated a one-year clinical success of 78.9% with Varipulse. The trial defined success as freedom from documented symptomatic atrial arrhythmia recurence. inspIRE also demonstrated a notable safety profile with zero primary adverse events.
The company reported a simplified workflow and minimal fluoroscopy time (7.8 minutes), plus efficient procedures (70 minutes). Biosense Webster attributed this to the platform’s proprietary pulse sequence, catheter design and Carto 3 integration.
PFA competition continues to heat up. Last month, Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib. Boston Scientific just last week said it expects FDA approval for its Farapulse PFA system in the first quarter of 2024.
Varipulse is pending CE mark in Europe and remains unavailable for sale in the EU and U.S.
“We are excited to continue to advance PFA clinical studies globally and look forward to the positive impact this innovation will deliver to patients everywhere,” said Jasmina Brooks, president, Biosense Webster.