We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on an iliac vein stent system. Both technical and clinical requirements are outlined below. In the end, it is the risk and benefit analysis that got its NMPA approval. Through this case, you will know which are typically required to obtain the China NMPA approval. We hope that you will find our best practice sharing helpful for your implant device submissions in China. We have successfully registered different types of stents such as intracranial stent, thoracic aortic stent, drug eluting coronary stent, intestinal stent, ureteral stent, etc.
Non-Clinical Stent China NMPA
Product structure and composition
The iliac vein stent system consists of an iliac vein stent and a delivery system. The delivery system consists of components such as delivery sheath assembly, push rod assembly, tip and handle. Sterilized by ethylene oxide, single use.
Intended use
The product is intended for use in the common iliac vein for the treatment of non-thrombotic iliac vein compression syndrome.
Work mechanism
The iliac vein stent is delivered to the lesion site through the delivery system, and the stent expands naturally. The stent will exert an abduction force on the lumen surface of the blood vessel to provide support for the compressed vein, thereby improving venous return.
Product performance evaluation
Product performance evaluation mainly includes in vitro simulation performance, fatigue performance, MRI compatibility research, hemodynamic research, finite element analysis research and other related research on product technical requirements. The results show that the product meets the design input requirements.
Biocompatibility
The product consists of two parts, a stent and a delivery system. The stent is an implanted device, which is in long-term contact with circulating blood; the delivery system is an external access device, which is in short-term contact with circulating blood. The biocompatibility evaluation of the external access devices was carried out respectively, based on the GB/T 16886 series of standards.
For specific Biocompatibility evaluation items, please contact us or email info@ChinaMedDevice.com.
Sterilization
This product is sterilized with ethylene oxide and is provided in a sterile state. Sterility assurance level is 10-6.
Product expiration date and packaging
The shelf life of this product is two years. Accelerated aging verification test and real-time aging verification test were carried out, and research projects included product stability and packaging integrity verification. A transport stability verification study was carried out.Animal research
An animal experimental study using pig as a model was carried out. The operability and immediate safety and efficacy of the device were evaluated by device operation and DSA imaging, and the safety and efficacy after stent implantation (30 days, 60 days, 90 days, and 180 days) were analyzed by histopathological sections and DSA imaging.
Clinical Stent China NMPA
The clinical trial was a multi-center, randomized controlled, parallel, non-inferiority design, carried out in 19 clinical institutions, and plans to include 256 subjects to verify the safety and efficacy of the product.
The primary efficacy indicator was the patency rate of the iliac vein (defined as the degree of lumen stenosis <50%) at 12 months after surgery.
The secondary efficacy indicator and the safety indicators include: device success rate, minimum lumen diameter of iliac vein at 12 months after operation, degree of stenosis of iliac vein diameter at 12 months after operation, surgical success rate, venous clinical symptoms at 3/12 months after operation Changes in severity (VCSS) score, CEAP grade at 3/12 months postoperatively, and incidence of adverse events (AEs) and serious adverse events (SAEs).
For the results of the clinical trial, please email info@ChinaMedDevice.com
Risk-benefit Analysis
The main benefit brought by the product is: treatment of common iliac vein stenosis or occlusion through stent implantation. Iliac vein stenting is a common method for the treatment of iliac vein stenosis or occlusion. Stent implantation solves the stenosis or occlusion of the iliac vein outflow tract therefore the venous return obstruction of the pelvis and lower extremities can be improved.
The main risks are pulmonary embolism, stent thrombosis, severe postoperative bleeding and the need for secondary intervention.
For the labeling with handling instruction and precautions, please email us at info@ChinaMedDevice.com.
About China Med Device, LLC
China Med Device, LLC provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.
