Shanghai, China – On August 11, Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP") obtained the regulatory approval from China Food and Drug Administration ("CFDA") for its in-house developed PathBuilder™ Transseptal Guiding Introducer and Needle ("PathBuilder™").
PathBuilder™ is comprised of introducer (including a sheath, dilator and guide wire as its components) and needle (including needle body and stylet). The device 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, including introducing the guiding catheter to left atrium by the atrial septal puncture.
The CFDA approval of PathBuilder™ marks the official launch of MicroPort® EP's first passive appliance in the domestic market and signifies another solid step of MicroPort® EP in becoming the provider of "a complete solution platform combining active and nonactive, device and equipment."