Shanghai MicroPort EP MedTech Co., Ltd. (“MicroPort EP”) obtained FDA(Food and Drug Administration)approval in U.S.A for its in-house developed PathBuilder™ Steerable Introducer.This is the first MicroPort EP product to receive FDA approval.
Arrhythmia is a common disease of cardiovascular diseases, and RF ablation is an important treatment for arrhythmia. The PathBuilder™ is specially indicated for the RF ablation of cardiac arrhythmias. It is used to enter the femoral vein and establish a vascular access, and guide the diagnostic catheter or ablation catheter to enter each cardiac chamber,assist catheter to target position and provide support.
FDA is one of the internationally recognized authorities. The approval of the PathBuilder™ Steerable Introducer by FDA marks the safety and effectiveness,which lays a solid groundwork for the company’s further exploration in North America market.
In the future, MicroPort EP will continue to build a differentiated product portfolio and expand its global reach, offering comprehensive solutions for diagnosis and therapy of EP interventions for doctors and patients worldwide.