Four Innovative Medical Devices Approved in China, Including Iliac Vein Stent System and Spinal Cord Stimulation Test Electrode

On April 21, the National Medical Products Administration approved the listing of four products, namely, the iliac vein stent system, knee joint replacement surgery navigation and positioning system, spinal cord nerve stimulation test electrode, and knee joint replacement surgery navigation and positioning system.

1. Iliac Vein Stent System (Suzhou Tianhong Shengjie Medical Device Co., Ltd.)

This product is composed of an iliac vein stent and a delivery system. The iliac vein stent is made of nickel-titanium alloy. The delivery system consists of components such as a delivery sheath assembly, push rod assembly, tip, and handle. This product is used within the common iliac vein to treat non-thrombotic iliac vein compression syndrome.

The special design of this product can reduce the impact of the stent on the blood reflux of the contralateral iliac vein, improve the accuracy of stent positioning and release, better solve the problem of iliac vein compression, and increase the flexibility of the product.

2. Knee Joint Replacement Surgery Navigation and Positioning System (Gu Sheng Yuan Hua Robotics (Shenzhen) Co., Ltd.)

This product is composed of a robotic arm system, a navigation system, a main control console system, and surgical electric tools. When used in conjunction with verified knee prostheses and positioning tools, it is utilized for the navigation and positioning of knee prostheses and surgical tools during adult total knee replacement surgeries.

The core technologies of this product include registration and alignment algorithms, navigation osteotomy safety control algorithms, and robotic arm intraoperative motion tracking algorithms, among others. In total knee arthroplasty, a gear-driven, seven degrees-of-freedom robotic arm system holds the surgical electric tools, assisting doctors in completing the procedure. The surgical navigation and positioning accuracy meets clinical requirements, reducing X-ray radiation exposure to both doctors and patients.

3.Spinal Cord Stimulation Test Electrode (Beijing Pins Medical Co., Ltd.)

This product is composed of electrodes, guidewires, puncture needles, and steel wires. When used in conjunction with compatible external test stimulators, programmers, and multi-electrode test cables, it is utilized to evaluate the therapeutic effect of spinal cord nerve stimulation systems on chronic intractable pain in the trunk and limbs.

This product can automatically invoke pre-set stimulation parameters based on the patient's posture, allowing the patient to achieve a satisfactory therapeutic state. It also supports remote programming, providing a method for parameter adjustment without the need for patients to visit the hospital, thereby reducing the number of hospital visits.

4. Knee Joint Replacement Surgery Navigation and Positioning System (Suzhou Minimally Invasive Changxing Robotics Co., Ltd.)

This product is composed of a navigation console (navigation cart, optical navigation device, display), surgical platform (robotic arm, surgical cart), surgical assistance tools, optical positioning markers, foot pedal switch, and cables. When used in conjunction with verified knee prostheses, it is utilized for the navigation and positioning of knee prostheses and surgical tools during adult total knee replacement surgeries.

The core technologies of this product include robotic osteotomy positioning technology under navigation guidance and a multi-margin safety protection mechanism. In total knee arthroplasty, a 6-degree-of-freedom robotic arm is used to hold the bone plate, which, compared with traditional knee replacement surgery, can reduce patient trauma. The surgical navigation and positioning accuracy meets clinical usage requirements and reduces X-ray radiation exposure to both patients and doctors.