ElectroPolishing for Cost Effective, High Yield Nitinol Stent Fabrication

DESCRIPTION (provided by applicant): Faraday Technology proposes to develop the FARADAYIC [ElectroPolishing Process, based on pulse reverse electrolytic polishing of stents, fabricated from nitinol and other materials of interest to industry, for rapid, cost-effective surfce finishing] in a simple aqueous electrolyte. This process will minimize the process control difficulties and high reject rates associated with [conventional electropolishing of stents using mixed high concentration acid electrolytes, including sulfuric, phosphoric, hydrofluoric and perchloric acids. The presence of strong acids presents a serious issue in terms of surface contamination and worker exposure. Furthermore, the lack of robustness of the current electropolishing process resultsin high stent reject rates, approaching 40- 50%.] Compared to conventional electropolishing, FARADAYIC ElectroPolishing will provide a uniformly smooth surface using a simple 17 wt% sulfuric acid electrolyte. The specific aims of the Phase II effort are to optimize the [ElectroPolishing process], transition to an -scale pilot manufacturing apparatus, and work with our industrial collaborators to prepare this technology for full-scale industrial implementation. The measures of merit for the Phase II project will include: [1) surface finish, based on industrial stent specifications, 2) polishing rate, 3) dimensional tolerance, and ) corrosion resistance]. Faraday will be assisted by Dr. Lyle Zardiackas and Dr. Michael Roach of the University of MississippiMedical Center. The proposed project meets the NIH mission by developing an innovative stent manufacturing process with the overall aim of addressing technological innovation in the U.S. manufacturing economy consistent with Executive Order Encouraging Innovation in Manufacturing . This technology will enable a rapid, high yield, cost-effective manufacturing process for nitinol stents, [and will be compatible with stents and other medical devices fabricated from a wide variety of materials. Stents represent one of the fastest growing segments of the medical device market. From their introduction in 1990, the stent market has grown to over 5 billion in 2011.] To achieve the objectives of the Phase II, Faraday will complete tasks that include optimizing the FARADAYIC [ElectroPolishing process], transitioning to tubular stents, evaluating the FARADAYIC Processes for other materials of interest to industry, designing and building an -scale pilot manufacturing apparatus for demonstration of continuous, industrial-scale processing of Nitinol stent tubes, and completing manufacturing process flow, economic assessment, quality plan, and development of documentation, processes and procedures for compliance with FDA regulations. This effort is designed to move intoa Phase III program, in which the technology would be transitioned to our industrial collaborators. PUBLIC HEALTH RELEVANCE: The proposed program will enable high yield, high precision manufacturing of expandable vascular endoprostheses devices,or stents. Increasing the yield and precision of the stent will lower the cost and failure rate of these devices, with immediate benefit to the public health. Furthermore, this manufacturing technology is compatible with [stents and other implants manufactured from a wide range of biocompatible materials].