Regulatory approval of peripheral endovascular revascularization devices in the United States: Is the horse still in the barn?

American Journal of Therapeutics

Volumn 12, Issue 2, 2005, Pages 186-191

  Weinberger, Judah ^a,b   Rundback, John H ^a   Ratchford, Elizabeth V ^a  

^a NewYork Presbyterian Hospital   (United States)

^b Och Spine at New York Presbyterian Hospitals   (United States)

Author keywords

Devices; Endovascular; FDA; Peripheral vascular disease; Regulatory approval

Indexed keywords

ANGIOPLASTY; ARTERY DISEASE; CLINICAL TRIAL; CONFERENCE PAPER; DEVICE; ENDOVASCULAR REVASCULARIZATION DEVICE; EVALUATION; FOOD AND DRUG ADMINISTRATION; HUMAN; MARKETING; MEDICAL INSTRUMENTATION; MEDICAL TECHNOLOGY; PERFORMANCE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROTECTION; REVASCULARIZATION; SAFETY; SAPHENOUS VEIN; STENT; UNITED STATES;

ANGIOPLASTY, BALLOON; CLINICAL TRIALS; DEVICE APPROVAL; HUMANS; PERIPHERAL VASCULAR DISEASES; PRACTICE GUIDELINES; STENTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VASCULAR SURGICAL PROCEDURES;

EID: 17144372273     PISSN: 10752765     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.mjt.0000155118.55919.a7     Document Type: Conference Paper

References (17)

1. Heidrich H, Wenk R, Hesse P. Frequency of asymptomatic peripheral arterial disease in patients entering the department of general and internal medicine of a general-care hospital. Vasa. 2004;33:63-67.
2. Hooi JD, Kester AD, Stoffers HE, et al. Asymptomatic peripheral arterial occlusive disease predicted cardiovascular morbidity and mortality in a 7-year follow-up study. J Clin Epidemiol. 2004;57:294-300.
3. Murphy TP, Soares G, Kim M. Increase in utilization of percutaneous renal artery interventions by medicare beneficiaries, 1996-2000. AJR Am J Roentgenol. 2004;183: 561-568.
4. Murphy TP, Soares G, Kim M. Increase in utilization of percutaneous renal artery interventions by medicare beneficiaries, 1996-2000. AJR Am J Roentgenol. 2004;183: 561-568.
5. http://www.fda.gov/cdrh/annual/fy2003/bringing.html.
6. http://www.fda.gov/cdrh/devadvice/index.html.
7. http://www.fda.gov/cdrh/annual/fy2003/fy2003.pdf.
8. http://www.fda.gov/cdrh/ode/guidance/1332.html.
9. Tandy MK. Industry perspective on FDA regulation of medical devices and the practice of medicine. Ann Thorac Surg. 1996;61:485-486.
10. http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004- 066b1_22_Belmont%20Report.doc.
11. Forrester JS, Topol EJ, Abele JE, et al. Task Force 5: assessment, approval, and regulation of new technology. J Am Coll Cardiol. 1997;29:1171-1179.
12. Baim DS, Wahr D, George B, et al. Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts. Circulation. 2002;105:1285-1290.
13. Smith JJ. Regulation of medical devices in radiology: current standards and future opportunities. Radiology. 2001;218:329-335.
14. Sacks D, Marinelli DL, Martin LG, et al. Society of Interventional Radiology Technology Assessment Committee. General principles for evaluation of new interventional technologies and devices. J Vasc Interc Radiol. 2003; 14:S391-S394.
15. http://www.fda.gov/ohrms/dockets/ac/01/minutes/3747m1.htm.
16. Lonn E. The use of surrogate endpoints in clinical trials: focus on clinical trials in cardiovascular diseases. Pharmacoepidemiol Drug Saf. 2001;10:497-508.
17. http://www.cms.hhs.gov/faca/mcacpage.asp.