Recently, the innovative product Disposable Radiofrequency Atrial Septal Puncture Needle of Hangzhou Nuosheng Medical Technology Co., Ltd. is approved for marketing by China NMPA.

The Disposable Radiofrequency Atrial Septal Puncture Needle consists of a catheter with a radiofrequency puncture electrode tip and a control handle. It is used in conjunction with the radiofrequency generator and the steerable catheter sheath produced by the same company via the femoral vein approach. It is indicated for patients who are planned to undergo interventional treatment in the department of cardiology through the transseptal puncture route. It helps to perform atrial septal puncture from the right atrium to the left atrium and establish a passage between them, facilitating the smooth entry of subsequent interventional treatment devices into the left atrium.

Compared with traditional mechanical atrial septal puncture products, this product uses radiofrequency energy for puncture, requiring less mechanical force and making the puncture process more controllable. The distal end is made of a flexible and bendable material. When used in combination with other adjustable devices, it can precisely adjust the angle to reach the target tissue and avoid causing damage to non-target tissues. The outlet of the fluid channel is closer to the electrode tip, making the puncture more precise and safer. The handle is equipped with an energy control switch, which has a shorter response time than a foot pedal switch, thus improving the success rate and safety of atrial septal puncture surgeries.

The NMPA will strengthen the post-marketing surveillance of these products to protect the safety of medical devices used by patients.