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Recently, after review, the State Medical Products Administration approved the registration application
for the innovative product "disposable pressure monitoring magnetic positioning radiofrequency ablation catheter" produced by Shanghai MicroPort Electrophysiological Medical Technology Co.
, Ltd.
for the innovative product "disposable pressure monitoring magnetic positioning radiofrequency ablation catheter" produced by Shanghai MicroPort Electrophysiological Medical Technology Co.
, Ltd.
The product consists of
a radiofrequency ablation catheter, a connecting tail and a tail connection box.
The catheter body contains a high-torque tube body and a bendable head with platinum-iridium electrodes, 1 head terminal electrode and 3 ring electrodes
.
The product is used in medical institutions with the three-dimensional cardiac electrophysiological mapping system and cardiac radiofrequency ablation instrument produced by Shanghai MicroPort Electrophysiology Medical Technology Co.
, Ltd.
for the treatment
of drug-refractory, recurrent and symptomatic paroxysmal atrial fibrillation.
a radiofrequency ablation catheter, a connecting tail and a tail connection box.
The catheter body contains a high-torque tube body and a bendable head with platinum-iridium electrodes, 1 head terminal electrode and 3 ring electrodes
.
The product is used in medical institutions with the three-dimensional cardiac electrophysiological mapping system and cardiac radiofrequency ablation instrument produced by Shanghai MicroPort Electrophysiology Medical Technology Co.
, Ltd.
for the treatment
of drug-refractory, recurrent and symptomatic paroxysmal atrial fibrillation.
The product adopts pressure sensing technology, magnetic field positioning technology, head porous saline perfusion technology and three-dimensional electrophysiological mapping system based on the principle of strain gauges, which can provide an overall solution for the treatment of patients with atrial fibrillation, and is the first cardiac radiofrequency ablation catheter
with pressure sensing function in China.
Compared with the traditional cardiac radiofrequency ablation catheter, this product can measure the contact pressure value between the catheter tip and the heart wall in real time, which can better assist the surgeon to complete the operation, effectively prevent the incomplete ablation caused by excessive adhesion force between the catheter and the tissue during the operation, shorten the learning curve of doctors, and achieve a better long-term treatment success rate
.
with pressure sensing function in China.
Compared with the traditional cardiac radiofrequency ablation catheter, this product can measure the contact pressure value between the catheter tip and the heart wall in real time, which can better assist the surgeon to complete the operation, effectively prevent the incomplete ablation caused by excessive adhesion force between the catheter and the tissue during the operation, shorten the learning curve of doctors, and achieve a better long-term treatment success rate
.
The approval of this product is conducive to the clinical application and promotion of this technology and the reduction of clinical treatment costs, benefiting more patients with atrial fibrillation
.
.
The drug administration department will strengthen the post-marketing supervision of the product to protect the safety of
patients.
patients.
