1. PwC analysis. Available at: http://clinicaltrials.gov Accessed August 10, 2016.
2. Shuren J. Continuing America’s leadership: the future of medical innovation for patients. Statement of Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, Food and Drug Administration Department of Health and Human Services, before the Committee on Health, Education, Labor and Pensions, United States Senate. April 28, 2015. Available at: http://www.help.senate.gov/imo/media/doc/Shuren3.pdf. Accessed August 10, 2016.
3. Food and Drug Administration, Center for Biologics Evaluation and Research. Investigational device exemptions (IDEs) for early feasibility medical device clinical studies, including certain first in human (FIH) studies: guidance for industry and Food and Drug Administration staff. 2013. Available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf. Accessed August 10, 2016.
4. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II;Feldman;J Am Coll Cardiol,2015
5. U.S. Food and Drug Administration. CFR – Code of Federal Regulations Title 21. Part 812. Investigational Device Exemptions. 2015. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812. Accessed August 10, 2016.