-
1
-
-
16544379129
-
Medical device development: From prototype to regulatory approval
-
Kaplan AV, Baim DS, Smith JJ, Feigal DA, Simons MS, Jefferys D, Fogarty TJ, Kuntz RE, Leon MB. Medical device development: from prototype to regulatory approval. Circulation. 2004;109:3068-3072.
-
(2004)
Circulation
, vol.109
, pp. 3068-3072
-
-
Kaplan, A.V.1
Baim, D.S.2
Smith, J.J.3
Feigal, D.A.4
Simons, M.S.5
Jefferys, D.6
Fogarty, T.J.7
Kuntz, R.E.8
Leon, M.B.9
-
2
-
-
16544372928
-
Post-market approval surveillance: A call for a more integrated and comprehensive approach
-
Mehran R, Leon MB. Feigal DA, Jefferys D, Simons MS, Chronos N, Fogarty TJ, Kuntz RE, Baim DS, Kaplan AV. Post-market approval surveillance: a call for a more integrated and comprehensive approach. Circulation. 2004;109:3073-3077.
-
(2004)
Circulation
, vol.109
, pp. 3073-3077
-
-
Mehran, R.1
Leon, M.B.2
Feigal, D.A.3
Jefferys, D.4
Simons, M.S.5
Chronos, N.6
Fogarty, T.J.7
Kuntz, R.E.8
Baim, D.S.9
Kaplan, A.V.10
-
3
-
-
0003820166
-
-
New Brunswick, NY: Johnson & Johnson
-
Annual Report. New Brunswick, NY: Johnson & Johnson; 2003.
-
(2003)
Annual Report
-
-
-
4
-
-
14344271133
-
Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study
-
Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IMF, Seixas AC, Staico R, Mattos LA, Sousa AGMR, Falotico R, Jaeger J, Popma JJ, Serruys PWS. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001;103:192-195.
-
(2001)
Circulation
, vol.103
, pp. 192-195
-
-
Sousa, J.E.1
Costa, M.A.2
Abizaid, A.3
Abizaid, A.S.4
Feres, F.5
Pinto, I.M.F.6
Seixas, A.C.7
Staico, R.8
Mattos, L.A.9
Sousa, A.G.M.R.10
Falotico, R.11
Jaeger, J.12
Popma, J.J.13
Serruys, P.W.S.14
-
5
-
-
0037030658
-
A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization
-
Morice M-C, Serruys PW, Sousa E, Fajadet J, Hayashi E, Perin M, Colombo A, Schule G, Barragan P, Guagliumi G, Molnar F, Falotico R, for the RAVEL Study Group. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773-1780.
-
(2002)
N Engl J Med
, vol.346
, pp. 1773-1780
-
-
Morice, M.-C.1
Serruys, P.W.2
Sousa, E.3
Fajadet, J.4
Hayashi, E.5
Perin, M.6
Colombo, A.7
Schule, G.8
Barragan, P.9
Guagliumi, G.10
Molnar, F.11
Falotico, R.12
-
6
-
-
0141765805
-
Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery
-
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE, for the SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-1323.
-
(2003)
N Engl J Med
, vol.349
, pp. 1315-1323
-
-
Moses, J.W.1
Leon, M.B.2
Popma, J.J.3
Fitzgerald, P.J.4
Holmes, D.R.5
O'Shaughnessy, C.6
Caputo, R.P.7
Kereiakes, D.J.8
Williams, D.O.9
Teirstein, P.S.10
Jaeger, J.L.11
Kuntz, R.E.12
-
7
-
-
33646821533
-
-
April 24
-
FDA announcement of Cypher approval, April 24, 2003. Available at: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00896.htmlAnnouncement of Cypher approval. Accessed April 27, 2005.
-
(2003)
FDA Announcement of Cypher Approval
-
-
-
8
-
-
33646802090
-
-
Miami Lakes, Fla: Cordis/A Johnson & Johnson Co; July 7
-
Donohue D. "Dear Colleague" letter. Miami Lakes, Fla: Cordis/A Johnson & Johnson Co; July 7, 2003.
-
(2003)
"Dear Colleague" Letter
-
-
Donohue, D.1
-
9
-
-
0043176210
-
Cordis corporation issues a health care professional letter regarding the CYPHER stent
-
July 8
-
Cordis corporation issues a health care professional letter regarding the CYPHER stent. FDA News, July 8,2003. Available at: http://www.fda.gov/bbs/ topics/NEWS/2003/NEW00919.html. Accessed February 8, 2005.
-
(2003)
FDA News
-
-
-
12
-
-
11144356029
-
Stent thrombosis after successful sirolimus-eluting stent implantation
-
Jeremias A, Sylvia B, Bridges J, Kirtane AJ, Bigelow B, Pinto DS. Ho KKL, Cohen DJ, Garcia LA, Cutlip DE, Carrozza JP. Stent thrombosis after successful sirolimus-eluting stent implantation. Circulation. 2004;109:1930-1932.
-
(2004)
Circulation
, vol.109
, pp. 1930-1932
-
-
Jeremias, A.1
Sylvia, B.2
Bridges, J.3
Kirtane, A.J.4
Bigelow, B.5
Pinto, D.S.6
Ho, K.K.L.7
Cohen, D.J.8
Garcia, L.A.9
Cutlip, D.E.10
Carrozza, J.P.11
-
13
-
-
20044366366
-
Thirty-day incidence and six-month outcome of thrombotic stent occlusion following bare metal, sirolimus or paclitaxel stent implantation
-
Ong ATL, Hove A, Aoki J, van Mieghem CAG, Granillo GAR, Sonnenschein K, Regar E, McFadden EP, Sianos G, van der Giessen WJ, de Jaegere PPT, de Feyter P, van Domburg RT, Serruys PW. Thirty-day incidence and six-month outcome of thrombotic stent occlusion following bare metal, sirolimus or paclitaxel stent implantation. J Am Coll Cardiol. 2005;45:944-950.
-
(2005)
J Am Coll Cardiol
, vol.45
, pp. 944-950
-
-
Ong, A.T.L.1
Hove, A.2
Aoki, J.3
Van Mieghem, C.A.G.4
Granillo, G.A.R.5
Sonnenschein, K.6
Regar, E.7
McFadden, E.P.8
Sianos, G.9
Van Der Giessen, W.J.10
De Jaegere, P.P.T.11
De Feyter, P.12
Van Domburg, R.T.13
Serruys, P.W.14
-
16
-
-
33646796874
-
-
Natick, MA. May 4, Boston Scientific Corporation
-
Boston Scientific announces preliminary information on U.S. Taxus sales for April, Natick, MA (May 4, 2004): Boston Scientific Corporation. Available at: http://www.bostonscientific.com/common_templates/articleDisplayTemplate. jhtml?task=tskPressRelease.jhtml§ionId=2&relId=24,25&uniqueId= ABPR4984. Accessed February 9, 2005.
-
(2004)
Boston Scientific Announces Preliminary Information on U.S. Taxus Sales for April
-
-
-
17
-
-
33646809917
-
-
Natick, MA (July 22)
-
Boston Scientific recalls 200 Taxus Stent Systems, Natick, MA (July 22, 2004). Available at: http://www.bostonscientific.com/common_templates/ articleDisplayTemplate.jhtml?task=tskPressRelease.jhtml§ionId= 2&relId=24,25&uniqueId=ABPR5408&clickType=endeca& acceptedWarning=PR. Accessed February 9, 2005.
-
(2004)
Boston Scientific Recalls 200 Taxus Stent Systems
-
-
-
18
-
-
33646814552
-
-
Natick, MA (August 5)
-
Boston Scientific Expands Recall of Taxus Coronary Stent System, Natick, MA (August 5, 2004). Available at: http://www.bostonscientific.com/ common_templates/articleDisplayTemplate.jhtml?task=tskPressRelease. jhtml§ionId=2&relId=24,25&uniqueId=ABPR5408&clickType= endeca&acceptedWarning=PR. Accessed February 9, 2005.
-
(2004)
Boston Scientific Expands Recall of Taxus Coronary Stent System
-
-
-
19
-
-
33646788220
-
BSX: Taxus market share returns: prospect of share repurchase offsets increased re-investment
-
September 2
-
Nudell B. BSX: Taxus market share returns: prospect of share repurchase offsets increased re-investment. Bernstein Research Call. September 2, 2004.
-
(2004)
Bernstein Research Call
-
-
Nudell, B.1
-
20
-
-
33646755998
-
Boston Scientific collects stents, offers assurances
-
July 20
-
Kerber R, and Krasner J. Boston Scientific collects stents, offers assurances. Boston Globe. July 20, 2004: A1.
-
(2004)
Boston Globe
-
-
Kerber, R.1
Krasner, J.2
-
22
-
-
9144265517
-
Surveillance of medical device-related hazards and adverse events in hospitalized patients
-
Samore MH, Evans RS, Lassen A, Gould P, Lloyd J, Gardner RM, Abouzelof R, Taylor C, Woodbury DA, Willy M, Bright RA. Surveillance of medical device-related hazards and adverse events in hospitalized patients. JAMA. 2004;291:325-334.
-
(2004)
JAMA
, vol.291
, pp. 325-334
-
-
Samore, M.H.1
Evans, R.S.2
Lassen, A.3
Gould, P.4
Lloyd, J.5
Gardner, R.M.6
Abouzelof, R.7
Taylor, C.8
Woodbury, D.A.9
Willy, M.10
Bright, R.A.11
-
23
-
-
0034723008
-
The relation between operator and hospital volume following percutaneous coronary interventions in the era of the coronary stent
-
McGrath PD, Wennberg DE, Dickens JD Jr, Siewers AE, Lucas FL, Malenka DJ, Kellett MA Jr, Ryan TJ Jr. The relation between operator and hospital volume following percutaneous coronary interventions in the era of the coronary stent. JAMA. 2000;284:3139-3144.
-
(2000)
JAMA
, vol.284
, pp. 3139-3144
-
-
McGrath, P.D.1
Wennberg, D.E.2
Dickens Jr., J.D.3
Siewers, A.E.4
Lucas, F.L.5
Malenka, D.J.6
Kellett Jr., M.A.7
Ryan Jr., T.J.8
-
24
-
-
0032858882
-
Changing outcomes in percutaneous coronary interventions: A study of 34,752 procedures in northern New England, 1990-1997
-
McGrath PD, Malenka DJ, Wennberg DE, Shubrooks SJ Jr, Bradley WA, Robb JF, Kellett MA Jr, Ryan TJ Jr, Hearne MJ, Hettleman B, O'Mear JO, Ver Lee P, Watkins MW, Piper WD, O'Connor GT, for the Northern New England Cardiovascular Disease Study Group. Changing outcomes in percutaneous coronary interventions: a study of 34,752 procedures in northern New England, 1990-1997. J Am Coll Cardiol. 1999;34:674-680.
-
(1999)
J Am Coll Cardiol
, vol.34
, pp. 674-680
-
-
McGrath, P.D.1
Malenka, D.J.2
Wennberg, D.E.3
Shubrooks Jr., S.J.4
Bradley, W.A.5
Robb, J.F.6
Kellett Jr., M.A.7
Ryan Jr., T.J.8
Hearne, M.J.9
Hettleman, B.10
O'Mear, J.O.11
Ver Lee, P.12
Watkins, M.W.13
Piper, W.D.14
O'Connor, G.T.15
-
25
-
-
0037385104
-
Adjusting for patient differences in predicting hospital mortality for percutaneous coronary interventions in the Clinical Outcomes Assessment Program
-
Maynard C, Goss JR, Malenka DJ, Reisman M, for the Clinical Outcomes Assessment Program. Adjusting for patient differences in predicting hospital mortality for percutaneous coronary interventions in the Clinical Outcomes Assessment Program. Am Heart J. 2003;145:658-664.
-
(2003)
Am Heart J
, vol.145
, pp. 658-664
-
-
Maynard, C.1
Goss, J.R.2
Malenka, D.J.3
Reisman, M.4
-
26
-
-
0034642318
-
Percutaneous Coronary intervention in the current era compared with 1985-1986: The National Heart, Lung, and Blood Institute registries
-
Williams DO, Holubkov R, Yeh W, Bourassa MG, Al-Bassam M, Block PC, Coady P, Cohen H, Cowley M, Dorros G, Faxon D, Holmes DR, Jacobs A, Kelsey SF, King SB III, Myler R, Slater J, Stanek V, Vlachos HA, Detre KM. Percutaneous Coronary intervention in the current era compared with 1985-1986: the National Heart, Lung, and Blood Institute registries. Circulation. 2000;102:2945-2951.
-
(2000)
Circulation
, vol.102
, pp. 2945-2951
-
-
Williams, D.O.1
Holubkov, R.2
Yeh, W.3
Bourassa, M.G.4
Al-Bassam, M.5
Block, P.C.6
Coady, P.7
Cohen, H.8
Cowley, M.9
Dorros, G.10
Faxon, D.11
Holmes, D.R.12
Jacobs, A.13
Kelsey, S.F.14
King III, S.B.15
Myler, R.16
Slater, J.17
Stanek, V.18
Vlachos, H.A.19
Detre, K.M.20
more..
-
27
-
-
0037012437
-
A contemporary overview of percutaneous coronary interventions: The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR)
-
Anderson HV, Shaw RE, Brindis RG, Hewitt K, Krone RJ, Block PC, McKay CR, Weintraub WS. A contemporary overview of percutaneous coronary interventions: the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR). J Am Coll Cardiol. 2002;39:1096-1103.
-
(2002)
J Am Coll Cardiol
, vol.39
, pp. 1096-1103
-
-
Anderson, H.V.1
Shaw, R.E.2
Brindis, R.G.3
Hewitt, K.4
Krone, R.J.5
Block, P.C.6
McKay, C.R.7
Weintraub, W.S.8
-
28
-
-
33646792025
-
Comparison of outcomes for sirolimus-eluting stent in the E-Cypher Registry with those from randomised controlled trials (SIRIUS)
-
Abstract
-
Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa E, Urban P, Wijns W. Comparison of outcomes for sirolimus-eluting stent in the E-Cypher Registry with those from randomised controlled trials (SIRIUS). J Am Coll Cardiol. 2005;45:50A. Abstract.
-
(2005)
J Am Coll Cardiol
, vol.45
-
-
Gershlick, A.H.1
Guagliumi, G.2
Guyon, P.3
Lotan, C.4
Schofer, J.5
Seth, A.6
Sousa, E.7
Urban, P.8
Wijns, W.9
-
29
-
-
33646810648
-
Taxus Express stent usage patterns and clinical outcomes: Twelve-month results from the European subset of the Global Milestone-II Registry
-
Abstract
-
Niemela K, Chevalier B, Stoerger H, Bilodeau L, Brito F, Russell M. Taxus Express stent usage patterns and clinical outcomes: twelve-month results from the European subset of the Global Milestone-II Registry. J Am Coll Cardiol. 2005;45:50A. Abstract.
-
(2005)
J Am Coll Cardiol
, vol.45
-
-
Niemela, K.1
Chevalier, B.2
Stoerger, H.3
Bilodeau, L.4
Brito, F.5
Russell, M.6
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