Postmarket evaluation of breakthrough technologies

American Heart Journal

Volumn 156, Issue 2, 2008, Pages 201-208

  Rao, Sunil V ^a,b   Califf, Robert M ^a,c,d   Kramer, Judith M ^a,d   Peterson, Eric D ^a,d   Gross, Thomas P ^e   Pepine, Carl J ^f   Williams, David O ^g   Donohoe, Dennis ^h   Waksman, Ron ⁱ   Mehran, Roxana ^j   Krucoff, Mitchell W ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DURHAM VA MEDICAL CENTER   (United States)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d DUKE UNIVERSITY   (United States)

^e CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^f UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^g RHODE ISLAND HOSPITAL   (United States)

^h Department of Medical Affairs and Health Ecomomics Worldwide   (United States)

ⁱ WASHINGTON HOSPITAL CENTER   (United States)

^j NewYork Presbyterian Hospital   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DRUG ELUTING STENT; FINANCIAL MANAGEMENT; HUMAN; MEDICAL INSTRUMENTATION; MEDICAL PROFESSION; MEDICAL TECHNOLOGY; NONHUMAN; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH PROBLEM;

ANIMALS; DEVICE APPROVAL; DRUG-ELUTING STENTS; EQUIPMENT FAILURE; EQUIPMENT SAFETY; GOVERNMENT REGULATION; HUMANS; INDUSTRY; MODELS, ANIMAL; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 47849112565     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2008.01.036     Document Type: Article

References (36)

1. American Heart Association Web page. AHA statistical update. Heart disease and stroke statistics: 2006 update. Available at. http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.105.171600v1 Last accessed July 19, 2006
2. Foot D.K., Lewis R.P., Pearson T.A., et al. Demographics and cardiology, 1950-2050. J Am Coll Cardiol 35 (2000) 1067-1081
3. U.S. Food and Drug Administration Web site. Guidance for industry and FDA staff: expedited review of premarket submissions for devices. Available at. http://www.fda.gov/CDRH/mdufma/guidance/108.html Last accessed April 20, 2006
4. Groeneveld P.W., Heidenreich P.A., and Garber A.M. Trends in implantable cardioverter-defibrillator racial disparity: the importance of geography. J Am Coll Cardiol 45 (2005) 72-78
5. Cohen D.J., Bakhai A., Shi C., et al. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial. Circulation 110 (2004) 508-514
6. Iakovou I., Schmidt T., Bonizzoni E., et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293 (2005) 2126-2130
7. Myerburg R.J., Feigal Jr. D.W., and Lindsay B.D. Life-threatening malfunction of implantable cardiac devices. N Engl J Med 354 (2006) 2309-2311
8. O'Shea J.C., Kramer J.M., Califf R.M., et al. Part I: Identifying holes in the safety net. Am Heart J 147 (2004) 977-984
9. Peterson E.D., Hirshfeld Jr. J.W., Ferguson T.B., et al. Part II: Sealing holes in the safety net. Am Heart J 147 (2004) 985-990
10. Kessler D.A. Introducing MEDWatch: a new approach to reporting medications and device adverse effects and product problems. JAMA 269 (1993) 2765-2768
11. Gardner S., and Flack M. Designing a medical device surveillance network: report to congress. Centers for Devices and Radiological Health Web page. Food and Drug Administration Web site. Available at (1999). http://www.fda.gov/cdrh/postsurv/medsun.html Updated October 15, 1999. Last accessed April 20, 2006
12. U.S. Food and Drug Administration. Food and Drugs, Food and Drug Administration, Department of Health and Human Services, Medical Devices, Pre-market approval of medical devices (Title 21, Vol. 8). Available at (2007). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF RPart=814&showFR=1 Last accessed June 24, 2008
13. Center for Devices and Radiological Health. Ensuring the safety of marketed medical devices: CDRH's Medical Device Postmarket Safety Program. Page 31, 2006. Available at (2006). www.fda.gov/cdrh/postmarket/mdpi-report.pdf Last accessed January 22, 2007
14. Brown S.L., Bezabeh S., and Duggirala H.J. Center for Devices and Radiological Health Condition of Approval Studies as a Postmarket tool for PMA approved cohorts 1998-2000. Available at. www.fda.gov/oc/whitepapers/epi_rep.pdf Last accessed January 22, 2007
15. Institute of Medicine. Committee on Postmarket Surveillance of Pediatric Medical Devices. In: Field M., and Tilson H. (Eds). Safe medical devices for children (2006), National Academies Press, Washington, DC 183-198
16. Kaplan A.V., Baim D.S., Smith J.J., et al. Medical device development: from prototype to regulatory approval. Circulation 109 (2004) 3068-3072
17. Manufacturer and User Facility Device Experience Database MAUDE). Center for Devices and Radiological Health resources Web page. Food and Drug Administration Web site. Available at. http://www.fda.gov/cdrh/maude.html Last accessed January 20, 2006
18. Holmes Jr. D.R., Leon M.B., Moses J.W., et al. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation 109 (2004) 634-640
19. Stone G.W., Ellis S.G., Cox D.A., et al. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation 109 (2004) 1942-1947
20. Rao S.V., Shaw R.E., Brindis R.G., et al. On- versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR]). Am J Cardiol 97 (2006) 1478-1481
21. Muni N., and Gross T.P. Problems with drug-eluting coronary stents-the FDA perspective. N Engl J Med 351 (2004) 1593-1595
22. Wood S. Boston Scientific recalls additional 85 000 TAXUS stents; Brigham and Women's yanks Taxus from cath labs. Heartwire, 2004. Available at (2004). http://www.theheart.org/article/149651.do Last accessed April 20, 2006
23. Serruys P.W., Strauss B.H., Beatt K.J., et al. Angiographic follow-up after placement of a self-expanding coronary-artery stent. N Engl J Med 324 (1991) 13-17
24. Leon M.B., Baim D.S., Popma J.J., et al. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med 339 (1998) 1665-1671
25. Virmani R., Kolodgie F.D., and Farb A. Drug-eluting stents: are they really safe?. Am Heart Hosp J 2 (2004) 85-88
26. Donohoe D. Cordis Corporation alert letter: CYPHER stent. MedWatch Safety Alert Web page. Food and Drug Administration Web site. Available at. http://www.fda.gov/bbs/topics/news/cordis_ltr.pdf Last accessed January 22, 2007
27. FDA updates information for physicians on Cordis Cypher Stent. FDA talk paper. Food and Drug Administration Web site, 2003. Available at (2003). http://www.fda.gov/bbs/cdrh/safety/cypher.html Last accessed April 20, 2006
28. Alonge L., and Kroen M. FDA Public Health Web Notification: final update of information for physicians on sub-acute thromboses (SAT) and hypersensitivity reactions with use of the Cordis CYPHER sirolimus-eluting coronary stent. Food and Drug Administration Web site. Available at. http://www.fda.gov/cdrh/safety/cypher3.html Last accessed February 24, 2006
29. O'Riordan M. Boston Scientific is recalling approximately 200 TAXUS paclitaxel-eluting coronary stents. Heartwire, 2004. Available at (2004). http://www.theheart.org/article/148291.do Last accessed April 20, 2006
30. Nainggolan L. Row over temporary suspension of Taxus stent. Heartwire, 2005. Available at (2005). http://www.theheart.org/article/598705.do Last accessed April 20, 2006
31. Wood S. Taxus "no deflate" problems continue says Wall Street Journal, but FDA unconcerned. Heartwire, 2005. Available at (2005). http://www.theheart.org/article/523237.do Last accessed July 19, 2006
32. Meier B. FDA plans to intensify oversight of heart devices. N Y Times (2006). Available at http://www.nytimes.com/2006/04/07/business/07device.html?ex=1302062400 &en=8585ea9669704e68&ei=5088&partner=rsssnyt&emc=rss Last accessed May 29, 2008
33. Wood S. The Guidant recall: device strengths and weaknesses in the spotlight, 2005. Available at (2005). http://www.theheart.org/article/512423.do Last accessed April 20, 2006
34. U.S. Department of Health and Human Services. The least burdensome provisions of the FDA Modernization Act of 1997: concept and principles; final guidance for FDA and industry. Center for Devices and Radiological Health resources Web page. Food and Drug Administration Web site. Available at. http://www.fda.gov/cdrh/ode/guidance/1332.pdf Last accessed January 22, 2007
35. Kereiakes D.J., Kuntz R.E., Mauri L., et al. Surrogates, substudies, and real clinical end points in trials of drug-eluting stents. J Am Coll Cardiol 45 (2005) 1206-1212
36. Hodgson J.M., King S.B., Feldman T., et al. SCAI statement on drug-eluting stents: practice and healthcare delivery implications. Cathet Cardiovasc Int 58 (2003) 397-399