The NMPA granted Innovation Approvals to the following devices in July 2022:
Cardiovascular
- Transcatheter prosthetic pulmonary valve system
- Implantable left ventricular assist system
Radiology
- Gamma beam stereotactic radiation therapy system
Ear, Nose, and Throat
- ENT dual-source cone beam computed tomography equipment
The NMPA also issued the list of 167 innovation approvals since the pathway established in 2014.
The NMPA issued the list of 167 innovation approvals since the pathway established in 2014. For an English copy of the list, please email us at info@ChinaMedDevice.com
Download the NMPA Innovation Approval Procedure
Why These Devices Granted Innovation Approval July
The NMPA gives explanations for each approval:
Transcatheter prosthetic pulmonary valve system
The product consists of a pulmonary valve and a delivery system, which includes a delivery catheter system and a compression loading system. The pulmonary valve consists of a self-expanding nickel-titanium alloy stent, porcine pericardium leaflets and skirts, and sutures.
The design can make the anchoring of the valve stent more stable, suitable for patients with a wider range of pulmonary valve annulus of different anatomical shapes, while making the stent delivery safer and blood flow smoother. The design of the delivery system allows the valve to be compressed uniformly and uniformly. Improved loading efficiency and reduced risk of radial collapse during valve release.
This product is suitable for postoperative patients with congenital heart disease (age ≥ 12 years old, body weight ≥ 30kg) with severe pulmonary regurgitation (≥3+) with autologous right ventricular outflow tract, and needs to meet certain clinical use conditions (see the product for details). scope of application). The launch of the product will bring new treatment options to patients.
Implantable left ventricular assist system
This product consists of implanted parts (blood pump, ventricular sewing ring, artificial blood vessel protective frame), surgical tools (cardiac opening tool, screwing tool, percutaneous wire pulling tool, inlet tube protective cap, percutaneous wire extension for surgery) cable), external components (controller, controller power extension cord, AC power adapter, lithium-ion battery, battery charger, monitor (optional), monitor data cable, patient backpack and shower bag.
This product is used in conjunction with specific artificial blood vessels to provide mechanical support for the blood circulation of patients with advanced refractory left heart failure and is used for transitional treatment before heart transplantation or to restore cardiac function.
It is intended for use by medical institutions with heart transplant conditions and comprehensive post-operative care capabilities. Medical staff, out-of-hospital nurses and patients must pass corresponding training. Contraindicated in patients with intolerance to anticoagulant therapy.
This product adopts the main core technologies such as pump-machine integrated design, magnetic-fluid suspension, internal flow channel optimization, and double-redundancy drive, all of which have independent intellectual property rights. The key technical indicators of the ventricular assist system have reached the same international level.
Gamma beam stereotactic radiation therapy system
The product consists of host system, electrical control system, radiation therapy planning system software, therapy control system software, image guidance system and portal verification system. It is used for image-guided head stereotactic radiation therapy for solid tumors and lesions, Radiosurgery and Body Stereotactic Radiation Therapy.
This product integrates KV-level CBCT image guidance technology and real-time orthogonal imaging image guidance technology and has independent intellectual property rights. It is the first image-guided gamma ray stereotactic radiotherapy equipment in China.
The product adopts a drum structure design, and the KV-level X-ray image guidance module and MV-level EPID module are installed on the drum, which are coaxial and coplanar with the focusing treatment head in the structural layout, which can realize the CBCT imaging technology and orthogonal imaging technology. Image-guided setup verification and real-time image guidance based on orthogonal imaging technology.
The product can perform image-guided positioning verification based on CBCT imaging technology and orthogonal imaging technology for patients before treatment. The imaging system detects the patient’s positioning deviation before treatment and informs the control system to make necessary position adjustments to ensure that the correct The planned treatment target area is sent into the treatment area; real-time image guidance based on orthogonal imaging technology can be performed during the treatment process.
The real-time image guidance technology can monitor the changes of the patient’s position in real time, and adjust the patient position error beyond the clinical acceptable range in real time, to ensure the position accuracy of the target area of radiotherapy, improve the clinical efficacy of radiotherapy, avoid unnecessary irradiation of normal tissues, and ensure the position accuracy of patients during treatment.
In addition, the product is based on the EPID field verification system, which optimizes the daily quality control workflow. It can be used to measure the size and position of the collimator output field during the daily quality control process, verify the collimator position accuracy, and ensure irradiation. Dosage accuracy, improve product reliability, and provide basic guarantees for precise treatment.
ENT dual-source cone beam computed tomography equipment
The product consists of a large field of view imaging system, a small field of view imaging system, a control device, a scanning bed, a head support, a frame, a laser positioning light, and a workstation. X-ray cone beam tomography for ear, nose, throat airways, oral and maxillofacial area.
This product is the world’s first oral CBCT product with dual-source and dual-detector. Its core technology is dual-source imaging technology. It adopts small focus, high-power X-ray tube head and high-resolution detector to improve the spatial resolution.
Based on the needs of oral and maxillofacial imaging, X-ray cone beam tomography can be provided for ENT diseases. Its large field of view imaging system is used for routine imaging examinations of the oral and maxillofacial, nose and throat airways, and its small field of view imaging system has high spatial resolution for imaging examinations of the internal organs of the ear (middle ear, inner ear).