NIH Reporter #1IU1RD000665-01A2

Preclinical Testing Support for VA-Patented flexSTIM Implantable Pattern Generator

This opportunity is issued by a government agency in Cleveland, Ohio, focused on advancing medical device innovation for Veterans with spinal cord injury (SCI). - Government Buyer: - Agency: U.S. Department of Veterans Affairs (VA) - Location: Cleveland, Ohio - Project Scope: - Preclinical testing support for the VA-patented flexSTIM biomimetic implantable pattern generator (IPG) - Goal: Obtain a full Investigational Device Exemption (IDE) for a first-in-human clinical feasibility study - Device will be used with industry-standard intramuscular electrodes - Products/Services Requested: - Benchtop testing of the flexSTIM device - Good Laboratory Practice (GLP) biocompatibility testing - Long-term in-vivo testing - Collaboration with the FDA for regulatory compliance - Unique/Notable Requirements: - Device is a VA-patented technology (flexSTIM IPG) - Focus on pressure injury prevention for individuals with limited mobility, especially Veterans with SCI - No specific OEMs, part numbers, or purchase quantities provided - OEMs: - The flexSTIM device is a VA-patented technology; no commercial OEMs are named - No specific vendors or resellers are identified in the opportunity

Description

This project involves the development and testing of the VA-patented flexSTIM biomimetic implantable pattern generator (IPG) combined with industry-standard intramuscular electrodes. It aims to support preclinical testing for a full Investigational Device Exemption (IDE) to enable a first-in-human clinical feasibility study. The project addresses decreased muscle quality and the need for regular weight-shifting for persons with limited mobility, especially Veterans with spinal cord injury (SCI). Milestones include benchtop testing, GLP biocompatibility testing, and long-term in-vivo testing, with collaboration involving the FDA to improve health and quality of life for Veterans with SCI.

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