Health & Beauty

Recently, the State Drug Administration has reviewed and approved the registration application of two innovative products: the "Laparoscopic Endoscopic Surgery System" produced by Suzhou Kangduo Robot Co., Ltd. Sexual use of cryoablation balloon catheters".

The "Laparoscopic Endoscopic Surgery System" produced by Suzhou Kangduo Robot Co., Ltd. consists of a doctor's console, a patient's operating table, surgical instruments and accessories. The physician uses the master-slave control system to control the minimally invasive surgery and is used for laparoscopic surgery of the upper urinary tract in urology. The product doctor console is the core part of the laparoscopic surgery system. The doctor controls the 3D endoscope and surgical instruments through two main hand controllers and a foot pedal device to achieve surgical operations on patients. The patient operating platform is the operating part of the laparoscopic surgical system, and its main function is to support surgical instruments and laparoscopic equipment. With the operation of the main hand controller and the foot pedal device on the doctor's console, the robotic arm system performs corresponding operations. The joints of each robotic arm have multiple degrees of freedom of movement, which can improve the flexibility and precision of surgery, and filter out Human hands tremble naturally. Surgical instruments assist in the completion of surgical cutting, suturing, clipping, etc. The product has independent intellectual property rights. Compared with traditional laparoscopic surgery, this product can improve the quality of the operation and ensure the safety of the operation. Compared with imported products, it can reduce the cost of treatment and reduce the economic burden of patients.

Application for registration of innovative products of "disposable cryoablation balloon catheter" produced by Ningbo Shengjie Kang Biotechnology Co., Ltd. It is composed of balloon, catheter main body (vacuum outer tube, vacuum inner tube, return gas tube, intake tube, buffer tube, protection tube) and handle (handle seat, loop connection tube, vacuum connection tube, joint). Used in conjunction with a specific cryoablation device for adjuvant cryoablation after first transurethral resection of the bladder tumor (TURBt) in adult patients with T1 non-muscle invasive bladder cancer (NMIBC). At present, there is no bladder tumor cryotherapy medical device in China. Domestic probe-type cryo-medical device products are limited to the application of solid tumors, and imported balloon-type cryo-medical device products are limited to the application of cardiovascular system. The core technology of this product is that the catheter tip adopts an innovative balloon structure design, and the distal end of the balloon is concave, which can effectively freeze the side and distal end of the balloon. A buffer unit is also designed at the distal end of the balloon to increase product safety and facilitate the delivery of the catheter. The product has independent intellectual property rights, and the working principle is the first in China.