Registry Assessment of Peripheral Interventional Devices (RAPID) ‐ Superficial Femoral and Popliteal Evidence Development (SPEED) as First Device Evaluation Project

  • Overview

    Registry Assessment of Peripheral Interventional Devices (RAPID) is a program that developed a global case report form that will allow for total product life cycle (TPLC) regulatory decisions. Under the RAPID program we aim to run a series of projects and studies (i.e. SPEED). The SPEED project is the first project under the RAPID program and it was designed to develop objective performance criteria (OPC) for devices used for the treatment of peripheral arterial disease (PAD) with the aim to support and likely accelerate label expansions of Peripheral Vascular Intervention (PVI) devices. More information about RAPID is available on the Journal of Vascular Surgery (JVS) or J-STAGE website.

  • Impact for NESTcc

    Use of Real-World Data (RWD) to develop Objective Performance Criteria (OPCs) which once available could accelerate regulatory decisions for PVI Devices.

  • Organizations

    MDEpiNet Executive Operations Committee, Over 36 organizations including 3 registries/societies, 7 federal agencies, 12 device manufacturers, and 16 other related companies/organizations (A list of partnering organizations can be found under ‘Phase I’)

  • Principal Investigators

    Jose Pablo Morales, MD, U.S. Food and Drug Administration, Jack Cronenwett, MD, Society for Vascular Surgery, and Robert Thatcher, MBA, 4C Medical Technologies

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NESTcc's Test-Case study protocol on synthetic mid-urethral slings for stress urinary incontinence in women is open for public comment through June 12. More: bit.ly/2RM654T pic.twitter.com/fk4ore1Kmg 1 day ago

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: bit.ly/2RM654T pic.twitter.com/5owFLFq1Fl 1 week ago

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