Technology evolution is a slow process, developing over many years before FDA approval. Even promising prototypes39,40 may stall in any stage of the regulatory or financial hurdles required to implement new stroke technologies. Although many concepts for new stroke intervention devices originate in the United States, difficulty in overcoming FDA regulation has resulted in the testing and use of more products in European countries. As a result, the United States is losing its leadership position in the development of devices for stroke intervention treatment. Furthermore, European companies have little incentive to market successful devices in the United States, presumably because of regulatory hurdles. Mutually beneficial partnerships among basic science, engineering, medicine, and industry, combined with cooperation from the FDA, will enable trials of American devices to take place on American soil.
The Gates Vascular Institute was designed to provide excellent patient care and to foster development of new endovascular devices. This innovative design enables clinical and preclinical research to be conducted in the same building, as well as housing the Jacobs Institute, an independent partner focused on assisting in innovation and collaboration in an effort to treat vascular diseases (Figure). This design will enable research, prototyping, testing, and funding of new stroke technologies.
Dr Dumont reports no financial relationships. Dr Hopkins receives grant/research support from Toshiba; serves as a consultant to Abbott, Boston Scientific, Cordis, Micrus, and Silk Road; holds financial interests in AccessClosure, Augmenix, Boston Scientific, Claret Medical, Endomation, Micrus, and Valor Medical; holds a board/trustee/officer position with Access Closure and Claret Medical; serves on Abbott Vascular's speakers' bureau; and has received honoraria from Bard, Boston Scientific, Cleveland Clinic, Complete Conference Management, Cordis, Memorial Health Care System, and the Society for Cardiovascular Angiography and Interventions (SCAI).
We thank Paul H. Dressel, BFA, for assistance with preparation of the figure and Debra J. Zimmer for editorial assistance.
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