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.

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