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Four Neurological Devices Receive NMPA Innovation Approvals in January

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The NMPA granted Innovation Approval to four neurological devices in January 2022:

  • Beijing Pinchi: Dual-channel Implantable Deep Brain Stimulation System
  • Beijing Pinchi: Implantable Spinal Cord Stimulation System
  • Beijing Pinchi: Implantable Rechargeable Spinal Cord Stimulation System
  • Huake Precision: Neurosurgery Navigation and Positioning System

NMPA issued the list of 142 innovation approvals since the pathway established in 2014. For an English copy of the list, please email us at info@ChinaMedDevice.com to enquiry our translation services.

Download the NMPA Innovation Approval Procedure

Why They Are Approved

NMPA gives explanations for each approval:

Dual-channel Implantable Deep Brain Stimulation System

The Pulse Generator Kit, Electrode Lead Kit and Extension Lead Kit products need to be used together to generate electrical stimulation pulses to stimulate the subthalamic nucleus (STN) for the treatment of advanced levodopa-responsive paroxysmal symptoms that cannot be effectively controlled by drugs. Combination therapy in patients with Kinson’s disease.

The above products have anti-interference design, can accept 3.0T field strength magnetic resonance imaging examination, have complete independent intellectual property rights, and are the first medical devices in China. Electrode lead kits and extension lead kits are manufactured using a braided composite conductive shielding structure that coats the electrode leads, which can significantly reduce the temperature rise caused by radio frequency fields. Patients implanted with this type of product can not only perform MRI scans safely under 1.5T MRI equipment, but also scan under 3.0T MRI equipment, thereby obtaining high-quality MRI image data.

Implantable Spinal Cord Stimulation System

One of the implantable spinal cord nerve stimulation electrode products consists of implantable spinal cord nerve stimulation electrodes, electrode anchors, tunneling tools, simulation electrodes, surgical electrode channelers, torque screwdrivers and spare electrode anchors. Another implantable spinal cord nerve stimulation electrode product consists of implantable spinal cord nerve stimulation electrodes, electrode anchors, tunneling tools, guide wires, puncture needles, steel wires, torque screwdrivers and spare electrode anchors. The implantable spinal cord nerve stimulation extension lead is composed of an extension lead, a sleeve, a backup screw, a tunneling tool, and a torque screwdriver. The above products are used in conjunction with a suitable implantable spinal cord nerve stimulator for patients aged 18 and above (except pregnant women) for the adjuvant treatment of chronic intractable pain in the trunk and limbs.

The implantable spinal cord nerve stimulation electrodes and implantable spinal cord nerve stimulation extension wires mainly adopt high-density connection and anti-bending fatigue core technology, and use the new sandwich electrode anchors, which can enhance the fixation force of the electrodes and reduce the electrode displacement rate. It is the first medical device in China.

Implantable Rechargeable Spinal Cord Stimulation System

The product is composed of pulse generator, torque screwdriver and plugging head. It is used in conjunction with the suitable implantable spinal cord nerve stimulation electrodes and implanted spinal cord nerve stimulation extension leads for patients aged 18 years and above (except pregnant women) for the adjuvant treatment of chronic intractable pain in the trunk and limbs.

The core technologies of the above products mainly include adaptive stimulation technology, multi-site synchronous stimulation technology, remote monitoring and program control technology, among which the implantable rechargeable spinal cord nerve stimulator has wireless charging technology. The product has complete independent intellectual property rights and is the first medical device in China. The preset stimulation parameters can be automatically called according to the patient’s posture, so that the patient can achieve a satisfactory treatment state. With remote program control function, it can adjust parameters remotely and reduce the number of patients going to and from the hospital.

Neurosurgery Navigation and Positioning System

The product consists of infrared camera, workstation, bracket, positioning components (probe, reference frame, connector, reflective ball, surgical instrument adapter), laser probe, hand-held laser sight, foot switch, automatic positioning device. For navigation and orientation positioning of neurosurgical instruments and implants.

This product mainly adopts core technologies such as multi-modal image fusion, laser surface registration, automatic positioning device, and has automatic positioning device. The product can improve the efficiency of surgery on the basis of ensuring the positioning accuracy, and can realize the basic functions of the robotic arm.

For any inquiries surrounding the NMPA’s Innovation Approval in January 2022, please contact us.

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