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Navigating the Regulatory Pathway for Medical Devices-a Conversation with the FDA, Clinicians, Researchers, and Industry Experts.
Lottes AE, Cavanaugh KJ, Chan YY, Devlin VJ, Goergen CJ, Jean R, Linnes JC, Malone M, Peat R, Reuter DG, Taylor K, Wodicka GR. Lottes AE, et al. Among authors: cavanaugh kj. J Cardiovasc Transl Res. 2022 Oct;15(5):927-943. doi: 10.1007/s12265-022-10232-1. Epub 2022 Mar 14. J Cardiovasc Transl Res. 2022. PMID: 35288821 Free PMC article. Review.
Editor's Choice - Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention.
Mao J, Sedrakyan A, Goodney PP, Malone M, Cavanaugh KJ, Marinac-Dabic D, Eldrup-Jorgensen J, Bertges DJ; Society for Vascular Surgery Vascular Quality Initiative and the Vascular Implant Surveillance and Interventional Outcomes Network. Mao J, et al. Among authors: cavanaugh kj. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):131-140. doi: 10.1016/j.ejvs.2022.08.014. Epub 2022 Aug 23. Eur J Vasc Endovasc Surg. 2023. PMID: 36007713 Free PMC article.
Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct.
Iwamoto S, Cavanaugh K, Malone M, Lottes A, Thatcher R, Kumar K, Rowland S, Fearnot N, Uchida T, Iwaishi C, Senshu K, Konishi R, Ikeda K, Suzuki Y, Ikeno F, Tamura A, Ho M, Ohashi M, Katayama H, Krucoff MW. Iwamoto S, et al. Cardiovasc Revasc Med. 2023 Jul;52:67-74. doi: 10.1016/j.carrev.2023.02.015. Epub 2023 Feb 24. Cardiovasc Revasc Med. 2023. PMID: 36870799
Standardized Data Elements for Patients With Acute Pulmonary Embolism: A Consensus Report From the Pulmonary Embolism Research Collaborative.
Rosenfield K, Bowers TR, Barnett CF, Davis GA, Giri J, Horowitz JM, Huisman MV, Hunt BJ, Keeling B, Kline JA, Klok FA, Konstantinides SV, Lanno MT, Lookstein R, Moriarty JM, Ní Áinle F, Reed JL, Rosovsky RP, Royce SM, Secemsky EA, Sharp ASP, Sista AK, Smith RE, Wells P, Yang J, Whatley EM; Pulmonary Embolism Research Collaborative (PERC) Attendees. Rosenfield K, et al. Circulation. 2024 Oct;150(14):1140-1150. doi: 10.1161/CIRCULATIONAHA.124.067482. Epub 2024 Sep 12. Circulation. 2024. PMID: 39263752 Review.
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). Hicks KA, et al. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048. J Am Coll Cardiol. 2018. PMID: 29495982 Free article. Review.
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