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Two Additive Manufactured Devices Gain Innovation Approvals in November

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The NMPA granted Innovation Approval to five medical devices in November 2023, including two additive manufactured devices:

  • Additive manufactured polyetheretherketone skull defect repair prosthesis
  • Additive manufactured customized knee joint prosthesis
  • Proton therapy system
  • Single photon emission and X-ray computed tomography system
  • Single-Incision laparoscopic surgery system
  • Disposable intracardiac echocardiography catheter
  • Collagen-Polydioxanone bilayer gingival repair membrane
  • Transcatheter mitral valve clip system

For an English copy of the “Tech Guide on Customized Additive Manufactured (3D Printing) Medical Device (Draft)”, please click HERE

Read more on Customize-designed additive manufactured (3D-printed) medical device technical review draft guideline

What are the Devices

Additive manufactured polyetheretherketone skull defect repair prosthesis

Based on the imaging data of patients with cranial defects, this product utilizes polyether ether ketone medical powder, processed through selective laser sintering additive manufacturing. It can match the patient’s defect site and achieve cranial defect replacement through three-dimensional embedding, restoring the original curvature of the patient’s cranial bone for three-dimensional reconstruction of the defect area.

This product is suitable for surgical treatment in the repair and reconstruction of cranial defects. Its use of additive manufacturing technology allows for the printing of more complex craniofacial bone morphologies. Additionally, the printing texture of the cranial defect repair prosthesis has no mechanical cutting effect on the scalp, eliminating the risk of the prosthesis penetrating through. Furthermore, the product addresses the issue of recycling polyether ether ketone powder in selective laser sintering, improving material utilization and reducing production costs while maintaining equivalent clinical effectiveness. The market availability of this product provides a new choice for patient treatment.

Additive manufactured customized knee joint prosthesis

The product includes a femoral condyle prosthesis, tibial plateau prosthesis, and meniscus prosthesis. The femoral condyle and tibial plateau prostheses are manufactured using cobalt-chromium-molybdenum powder through laser additive manufacturing, while the meniscus prosthesis is made from ultra-high molecular weight polyethylene material. The product features a personalized design for the entire knee joint prosthesis, and its biomechanical design of the joint surface can reconstruct normal patellofemoral joint movement.

The product is used in conjunction with bone cement and is suitable for knee joint prosthesis replacement, accommodating patients with osteoarthritis and other special cases. The product provides excellent coverage on various bone surfaces, effectively addressing issues of mismatch and excessive coverage. The market availability of this product will offer a new choice for patient treatment.

Proton therapy system

This product consists of an accelerator subsystem and a treatment subsystem. The accelerator subsystem includes the main accelerator system, energy selection system, and beam delivery system, while the treatment subsystem comprises three treatment rooms, including a 360-degree rotational beam therapy system and a treatment planning system. This product provides proton beam radiotherapy and is suitable for treating malignant tumors throughout the body and certain benign conditions. The specific indications are determined by the clinical physician based on the individual case.

It is the first approved proton therapy system to utilize superconducting cyclotron accelerator technology and a 360-degree rotational gantry. The mentioned technologies ensure a compact product design and the ability to perform treatments from multiple angles. At the same time, this product can effectively reduce patient treatment time while ensuring treatment effectiveness.

Single photon emission and X-ray computed tomography system

The product consists of a Single Photon Emission Computed Tomography (SPECT) system host (including two SPECT detectors), a CT system host frame, examination bed, PDU server, acquisition client workstation, SPECT acquisition server workstation, CT acquisition reconstruction workstation, image processing workstation, patient positioning monitor, SPECT collimator, and other components.

This product is clinically used for imaging examinations and assessments of tumors, the cardiovascular system, the urinary system, and neurological diseases. The SPECT component can also perform independent imaging. As the first domestic variable-angle, dual-head, general-purpose SPECT/CT integrated machine, this product not only fills a gap in the domestic market but also meets international advanced standards in various performance indicators. Its clinical applications can further enhance the diagnostic capabilities for tumors, ischemic heart disease, and kidney diseases in China, contributing to saving clinical resources and reducing medical costs.

Single-Incision laparoscopic surgery system

The product consists of a doctor’s control console, patient surgical platform, image processing unit, three-dimensional electronic laparoscope, surgical instruments, and accessories. This laparoscopic surgery system is designed for single-incision laparoscopic procedures and features surgical instruments with multiple degrees of freedom and a shoulder-elbow-wrist flexible hinge joint, enabling flexible and precise operation with a substantial load capacity.

In the implementation of laparoscopic surgery through a single incision, the laparoscope and surgical instruments have multiple active degrees of freedom. The surgery can be completed solely by the movement of the surgical instruments within the patient’s abdominal cavity, while the external positioning arm remains stationary during remote operation. This design helps to avoid the risk of collisions during surgery, enhances the precision of surgical operations, reduces the number of incisions in the patient’s abdomen, and minimizes surgical trauma.

Disposable intracardiac echocardiography catheter

This product consists of a catheter body, an operating handle, and a connector. When used in conjunction with the company’s portable color ultrasound diagnostic instrument, it is suitable for medical institutions to conduct ultrasound imaging of the heart, major blood vessels, and intracardiac anatomical structures.

The product utilizes high-frequency ultrasound waves to perform two-dimensional imaging and three-dimensional modeling of the heart, enabling accurate, rapid, and efficient ultrasound procedures. It provides real-time and precise anatomical images while monitoring hemodynamic changes. It exhibits excellent display of cardiac tissue characteristics and subtle structures, allowing for real-time monitoring and timely detection of surgery-related complications. This maximizes surgical safety, contributes to reducing clinical treatment costs, and facilitates timely intervention.

Collagen-Polydioxanone Bilayer Gingival Repair Membrane

This product is a white, membranous material with a fibrous layer structure. It is a three-layer composite membrane made through electrospinning technology, consisting of collagen and polydioxanone (PDO). The upper and lower layers are composed of collagen, while the middle layer is made of polydioxanone, and there is no distinction between the front and back sides. The collagen fiber layer is in contact with the wound surface, assisting in widening the keratinized gingiva, while the polydioxanone fiber layer adds mechanical strength to the composite membrane, facilitating manipulation and removal without direct contact with human tissues.

This product is suitable for widening keratinized gingiva in the oral cavity, deepening the vestibular sulcus. The appropriate model can be chosen based on the expected repair area.

Transcatheter Mitral Valve Clip System

This product consists of two components: a guiding sheath and the mitral valve clip system. The mitral valve clip system includes a mitral valve clip and a delivery system. The elastic central sealing mesh structure of the mitral valve clip enhances the sealing integrity, reduces central residual regurgitation, and lowers the closing force of the valve leaflets. Additionally, the mitral valve clip features functions such as individual leaflet capture and repetitive positioning and capturing, contributing to increased procedural accuracy and reduced risks of mitral valve clip detachment and leaflet perforation.

This product is suitable for patients with degenerative mitral regurgitation (MR ≥ 3+) whose anatomical structure is deemed appropriate for transcatheter intervention, especially when a heart team determines a high surgical risk.

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