Business
J&J MedTech gets Japanese regulatory approval for Varipulse PFA (NYSE:JNJ)
Johnson & Johnson (NYSE:JNJ) MedTech unit Biosense Webster said that Japanese regulators have approved its Varipulse Pulsed Field Ablation Platform, its first such approval for the product.
The platform was approved for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation, or AFib, using pulsed field ablation, or PFA. The system consists of the Varipulse Catheter, a variable loop multi-electrode catheter; the Trupulse Generator, a multi-channel PFA generator; and the Carto 3 System, a 3D cardiac mapping system.
Biosense Webster said the Varipulse Platform is the only PFA system approved in Japan. The system is not commercially available in the EU or US.
More on Johnson & Johnson
Source link