| Product Name | Transcatheter aortic valve and retrievable delivery system |
| Classification | Class III |
| Review Division | Center for Medical Device Evaluation of NMPA |
| Applicant Name | Shanghai MicroPort CardioFlow Medtech Co. Ltd. |
| Registration Pathway | Domestic Device Innovation Pathway |
| Product Description | Transcatheter aortic valve and retrievable delivery system consists of valve, delivery system, loading tool and guide wire. •The valve is composed of three leaflets (bovine pericardium), skirt (PET), clip (NiTi) and self expanding stent (NiTi) through suture (PTFE). •The delivery system which includes battery is mainly composed of conduit and handle. •The loading tool comprises a guide seat, a guide cover, a protective tube and tweezers. •The guide wire is composed of winding wire and core wire. The valve is sterilized with chemical liquid and is disposable with shelf life of 1 year. The delivery system, loading tools and guide wires are sterilized with ethylene oxide and are disposable with shelf life of 2 years. |
| Indications for Use | The product is intended for patients with severe degenerative autogenous aortic stenosis with symptomatic calcification and not for patients aged 70 years or older who underwent conventional surgical valve replacement |
| Summary of Non-Clinical Testing | The applicant submitted the following non-clinical research materials: •Product performance research •Biocompatibility •Bio-safety •Sterilization •Product shelf-life and packaging •Animal study •Safety index of active equipment Contact us to learn more about how to prepare the non-clinical study of this type of product |
| Summary of Clinical Evaluation | Clinical pathway: Combined CER pathway and clinical trail pathway •CER pathway: Select the listed products of the same manufacturer as the predicate. The main difference between the declared products and the predicate is that the delivery system is changed to a retrievable delivery system. •Clinical trail pathway: The study is a prospective, multicenter, single group target value clinical trial. It is planned to include 145 subjects to verify the safety and effectiveness of the product. Contact us to learn more about the clinical evaluation of this type of product |
| Product Risk/Benefit Analysis | Major benefits brought by the clinical use of the product to the applicable population are: •Improving the patient’s cardiac function; •Improving the patient’s quality of life; •Adjusting the valve release position through recycling operation. The major risks that the clinical use of the product may bring to the applicable population are the potential clinical risks brought by the retrievable function compared with the non retrievable delivery system. In addition to the known adverse events of transcatheter aortic valve, the potential risks of retrievable delivery system include: •Injury to aortic root; •Calcified plaque of vascular wall falls off; •Increase the incidence of calcified plaque embolism or cerebrovascular time. Contact us to learn more about the risk/benefit analysis of this type of product |
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