{"id":601674,"date":"2024-05-30T00:17:25","date_gmt":"2024-05-30T04:17:25","guid":{"rendered":"https:\/\/platohealth.ai\/nmpa-review-report-released-for-medtronics-renal-denervation-device\/"},"modified":"2024-05-30T08:04:09","modified_gmt":"2024-05-30T12:04:09","slug":"nmpa-review-report-released-for-medtronics-renal-denervation-device","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/nmpa-review-report-released-for-medtronics-renal-denervation-device\/","title":{"rendered":"NMPA Review Report Released for Medtronic\u2019s Renal Denervation Device","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The NMPA granted innovation approvals to Medtronic\u2019s renal denervation device and issued a review report.<\/p>\n

This is the sixth report published this year for imported devices, after those from Medtronic (Implantable deep brain stimulation directional lead), CarboFix Orthopedics, Intuitive Surgical, Abbott and Ivantis.<\/p>\n

The published review reports like this one serve as important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review the relevant ones for our clients\u2019 specific products to gain more clarity and be more efficient in their submission and approval process. As NMPA standardizes and streamlines the review process for fast-track approval, domestic and overseas players can benefit from our expertise and experience.<\/p>\n

Product overview<\/a><\/h3>\n

(I)Product structure and composition<\/p>\n

(II)Intended Use<\/p>\n

The product is intended for use in medical institutions and is designed to be used in conjunction with the renal artery radiofrequency ablation device produced by Medtronic (Model: RDNG3A, Software Release Version: 2). It is suitable for assisting in the treatment of resistant hypertension and hypertension in patients who are intolerant to medication.<\/p>\n

Resistant hypertension is defined as patients whose blood pressure is not adequately controlled despite the use of three or more antihypertensive drugs (including a diuretic) for more than three months.<\/p>\n

Medication intolerance refers to patients who cannot tolerate medication due to contraindications or adverse drug reactions.<\/p>\n

(III)Model\/Specification<\/p>\n

(IV)Working principle<\/p>\n

Pre-clinical<\/h3>\n

(I) Product Performance Research<\/p>\n

The applicant has provided documentation on product performance research and the development of product technical requirements, outlining the basis for determining functional and safety indicators such as physical properties, chemical properties, sterility, bacterial endotoxins, electrical performance, temperature measurement accuracy, electrical safety, and electromagnetic compatibility. The technical requirements for the product reference relevant national and industry standards, including YY 0285.1-2017 and YY 0778-2018.<\/p>\n

(II) Biocompatibility<\/p>\n

The applicant evaluated the biocompatibility of the catheter, which directly contacts the patient, according to GB\/T 16886.1-2011. The evaluation materials have brief contact with the human circulatory system and included biological tests (cytotoxicity, sensitization, intradermal reaction, acute systemic toxicity, pyrogen, hemolysis, complement activation, coagulation, in vivo thrombosis). A biological test report issued by an overseas testing institution was submitted, meeting the relevant requirements.<\/p>\n

(III) Sterilization<\/p>\n

The product is sterilized by the manufacturing enterprise through irradiation, with a sterility assurance level of 10^-6. The applicant has specified the sterilization method and parameters, and sterilization verification was conducted according to ISO 11137-1 standards. A sterilization verification report was submitted, and residual toxicity studies are not involved.<\/p>\n

(IV) Product Shelf Life and Packaging<\/p>\n

The product is for single use, with a shelf life of 3 years. The applicant conducted accelerated aging tests to verify the shelf life, testing the product and packaging under equivalent aging conditions. Post-aging tests on temperature measurement accuracy, power accuracy, working length, and sterility showed results that meet the requirements. The applicant also provided research data related to storage and transportation.<\/p>\n

(V) Animal Studies<\/p>\n

The applicant provided a total of four animal study reports:<\/p>\n