Shanghai, China – On October 13, Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP") obtained the registration certificate of China Food and Drug Administration ("CFDA") for its in-house developed FireMagic® Irrigated Ablation Catheter ("FireMagic® Cool Catheter").
Combined with radio frequency ablation device, FireMagic® Cool Catheter is indicated for use in treating ECG proven arrhythmia with definite clinical symptoms, including AVRT and AVNRT.
The catheter has a high-torque shaft with a deflectable curve section containing an array of the platinum electrodes. Tip deflection is controlled at the proximal end by a handle. The high-torque shaft also allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. It is a unidirectional catheter with four specifications of different curved shapes to meet patients' requirements.
At the proximal end of the catheter, a saline input port with a standard luer servers to permit the injection of normal saline to irrigate the tip eletrode. With connection to the irrigation pump, normal saline passes through the lumen of the catheter and come out from the saline irrigation holes at the surface of the tip electrod to irrigate and cool the ablation site, which to reach the purpose of deep ablation.
The CFDA approval of FireMagic® Cool Catheter signifies that the device officially enters in the China market to offer more choices to domestic patients.