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Boston Scientific’s First-of-its-Kind Sentinel Cerebral Protection System Gains NMPA Approval

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The NMPA granted innovation approval to Boston Scientific for the Sentinel Cerebral Protection System on November 2, 2022. The device belongs to “first-of-its-kind in China” scenario.

CMDE released the review report for Sentinel Cerebral Protection System. Below is the outline of the report, from the perspectives of product overview, preclinical research, clinical evaluation, and Benefit-risk determination.

For review reports on other devices, please ask info@ChinaMedDevice.com

Product Overview of the NMPA Sentinel Cerebral Protection System

Product Structure and Composition

The product consists of a 6F catheter with releasable proximal and distal filters, a connecting sheath, and a handle assembly. Electron beam sterilized, single use.

Intended use

This product is intended for use during transcatheter aortic valve replacement to capture and remove thrombus/tissue debris. The product filter should be placed at the brachiocephalic artery diameter of 9-15mm and the left common carotid artery diameter of 6.5-10mm.

Working principle

The Brain Protector is a percutaneously delivered, dual-filter protection device designed to capture and remove dislodged debris during transcatheter aortic valve replacement. The brain protector system works with one filter delivered to the brachiocephalic artery (proximal filter) and another filter delivered to the left common carotid artery (distal filter). After the procedure is complete, the filter and debris are put back into the catheter and removed from the patient.

Overview of Preclinical Research

Product Performance Research

The applicant provided product performance research materials and research on product technical requirements. The indicators in the product technical requirements refer to relevant national and industry standards, including: YY 0285.1-2017, GB/T 1962.1-2015 and GB/T 1962.2-2001, etc.

Biocompatibility

According to GB/T 16886.1-2011, the applicant has conducted a biocompatibility evaluation on the materials in the finished product that are in contact with patients, and the evaluated materials are short-term contact with circulating blood < 24 hours

Sterilization process research

Product is electron beam sterilized to a sterility assurance level of 10-6

Product expiration date and packaging

The product is for one-time use, and the shelf life is two years

Animal research

The applicant provided the animal research data of the previous generation of the declared product based on the pig in vivo model. Compared with the previous generation, the declared product has changed the control handle, the angle of the proximal filter support tube, the material of the outer sheath tube, the coating of the release wire, and the position of the grooved connecting tube.

After evaluation, the declared product does not need to carry out animal research again. In this study, a total of 4 animals were studied on the device according to the expected clinical use. The results of the study showed that all animals survived, no complications occurred during the study, and the device could be released and retrieved as expected.

Adverse events of the research procedure or device, the filter of the device contains tiny blood clots, etc., and the product meets the requirements for the intended use.

Overview of Clinical Evaluation

The applicant conducts clinical evaluation through the overseas clinical trial route. This overseas clinical trial adopted a prospective, multi-center, single-blind, randomized, and controlled trial design, and carried out clinical trials in 19 clinical research centers in the United States and Germany. A total of 363 subjects were enrolled in this overseas clinical trial.

In addition to the primary safety and efficacy endpoints, histopathological and histomorphology analysis of fragments were performed.

The applicant’s pooled analysis of overseas post-marketing clinical literature shows that it may benefit patients in terms of reducing 30-day mortality, stroke incidence, major bleeding, severe kidney injury, and severe vascular complications after TARV.

The declared product in normal use under the expected scope of application may generate additional clinical risks, and the product does not claim to reduce stroke occurrence or stroke severity and other related clinical effects, so the risk-benefit of the declared product is considered acceptable.

Benefit-risk Determination

The applicant has taken risk control measures for the currently known and predictable risks. It believes that the benefits to the applicable population outweigh the risks. To ensure the safety of the equipment, it is indicated in the IFU:

  1. Intended use
  2. Warnings and Precautions
  3. Contraindications