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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. Among authors: malone m. 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
Registry Assessment of Peripheral Interventional Devices (RAPID)　- Registry Assessment of Peripheral Interventional Devices Core Data Elements.
Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein R, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL. Jones WS, et al. Circ J. 2018 Jan 25;82(2):316-322. doi: 10.1253/circj.CJ-17-1156. Epub 2018 Jan 23. Circ J. 2018. PMID: 29367497 Free article. Review.
Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.
Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein RA, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL. Jones WS, et al. J Vasc Surg. 2018 Feb;67(2):637-644.e30. doi: 10.1016/j.jvs.2017.07.141. J Vasc Surg. 2018. PMID: 29389426 Free article.
Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.
Bertges DJ, White R, Cheng YC, Sun T, Ramkumar N, Goodney PP, Wilgus RW, Lottes AE, Smale JA, Drozda J, Raska M, Heise T, Jones WS, Tcheng JE, Eldrup-Jorgensen J, Sedrakyan A, Malone ML, Marinac-Dabic D, Thatcher R, Morales P, Krucoff MW, Cronenwett JL; Registry Assessment of Peripheral Interventional Devices (RAPID) and Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group. Bertges DJ, et al. Among authors: malone ml. J Vasc Surg. 2021 May;73(5):1702-1714.e11. doi: 10.1016/j.jvs.2020.09.030. Epub 2020 Oct 17. J Vasc Surg. 2021. PMID: 33080324 Free article.
Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program.
Lottes AE, Whatley EM, Royce SM, Bertges DJ, Erickson CA, Farb A, Fox ML, Jiang JH, Wang L, Lin AY, Malone ML, Papandreou G, Wilgus RW, Rosenfield K, Krucoff MW. Lottes AE, et al. Among authors: malone ml. Am Heart J. 2021 Feb;232:71-83. doi: 10.1016/j.ahj.2020.10.070. Epub 2020 Nov 4. Am Heart J. 2021. PMID: 33157067 Review.
Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices.
Bertges DJ, Eldrup-Jorgensen J, Robbins S, Ssemaganda H, Malone M, Marinac-Dabic D, Smale J, Lottes AE, Majithia A, Resnic FS; Society for Vascular Surgery Vascular Quality Initiative. Bertges DJ, et al. Among authors: malone m. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2598-2609. doi: 10.1016/j.jcin.2021.08.058. JACC Cardiovasc Interv. 2021. PMID: 34887051 Free article.
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: malone m. 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.
817 results