-
1
-
-
78650589643
-
What is value in health care?
-
Porter ME. What is value in health care? N Engl J Med. 2010;363:2477-2481.
-
(2010)
N Engl J Med.
, vol.363
, pp. 2477-2481
-
-
Porter, M.E.1
-
2
-
-
84878901319
-
The dynamics of pediatric device innovation: Putting evidence in context
-
Washington DC: Institute of Medicine, National Academy Press
-
Gelijns AC, Killelea B, Vitale M, Mankad V,Moskowitz AJ. The dynamics of pediatric device innovation: Putting evidence in context. In: Safe medical devices for children. Washington, DC: Institute of Medicine, National Academy Press; 2006:302-326.
-
(2006)
Safe Medical Devices for Children
, pp. 302-326
-
-
Gelijns, A.C.1
Killelea, B.2
Vitale, M.3
Mankad Vmoskowitz, A.J.4
-
3
-
-
0028141579
-
The dynamics of technological change in medicine
-
(Millwood)
-
Gelijns AC, Rosenberg N. The dynamics of technological change in medicine. Health Aff (Millwood). 1994;13:28-46.
-
(1994)
Health Aff
, vol.13
, pp. 28-46
-
-
Gelijns, A.C.1
Rosenberg, N.2
-
4
-
-
66249128241
-
Economic evaluation for devices and drugs-same or different?
-
Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs-same or different? Value Health. 2009;12:402-404.
-
(2009)
Value Health
, vol.12
, pp. 402-404
-
-
Drummond, M.1
Griffin, A.2
Tarricone, R.3
-
5
-
-
79955637666
-
Applying healTheconomics for policy decision making: Do devices differ from drugs?
-
Sorenson C, Tarricone R, Siebert M, Drummond M. Applying healTheconomics for policy decision making: Do devices differ from drugs? Europace. 2011;13(Suppl 2):ii54-ii58.
-
(2011)
Europace
, Issue.SUPPL. 2
, pp. 13
-
-
Sorenson, C.1
Tarricone, R.2
Siebert, M.3
Drummond, M.4
-
6
-
-
66249107886
-
Assessing the clinical and cost-effectiveness of medical devices and drugs: Are they that different?
-
Taylor RS, Iglesias CP. Assessing the clinical and cost-effectiveness of medical devices and drugs: Are they that different? Value Health. 2009;12:404-406.
-
(2009)
Value Health
, vol.12
, pp. 404-406
-
-
Taylor, R.S.1
Iglesias, C.P.2
-
7
-
-
84879167115
-
-
(accessed July 23 2013)
-
Ernst & Young. Pulse of the IndustryMedical Technology Report 2012.-http://www.ey.com/Publication/vwLUAssets/Pulse-medical-technology-report- 2012/$FILE/Pulse-medical-technology-report-2012.pdf (accessed July 23, 2013).
-
(2012)
Ernst & Young Pulse of the IndustryMedical Technology Report
-
-
-
8
-
-
84873472665
-
The economic evaluation of medical devices: Challenges ahead
-
Kirisits A, Redekop WK. The economic evaluation of medical devices: Challenges ahead. Appl HealThecon Health Policy. 2013;11:15-26.
-
(2013)
Appl HealThecon Health Policy
, vol.11
, pp. 15-26
-
-
Kirisits, A.1
Redekop, W.K.2
-
9
-
-
84860315152
-
-
US Food Drug Administration 2012 Monthly PMA Listings (accessed July 23 2013)
-
US Food and Drug Administration. Medical devices. 2012 Monthly PMA Listings. http://www.fda.gov/MedicalDevices/ProductsandMedical Procedures/DeviceApprovalsandClearances/PMAApprovals/ucm295841. htm (accessed July 23, 2013).
-
Medical Devices
-
-
-
10
-
-
84889608681
-
Medical devices
-
US Food Drug Administration (accessed July 23 2013)
-
US Food and Drug Administration. Medical devices. 2012 Medical Device 510(k) Clearances. http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/DeviceApprovalsandClearances/510k Clearances/ucm289685.htm (accessed July 23, 2013).
-
2012 Medical Device 510(k) Clearances
-
-
-
11
-
-
84866354519
-
Pre-market clinical evaluations of innovative high-risk medical devices in Europe
-
Hulstaert F, Neyt M, Vinck I, et al. Pre-market clinical evaluations of innovative high-risk medical devices in Europe. Int J Technol Assess Health Care. 2012;28:278-284.
-
(2012)
Int J Technol Assess Health Care
, vol.28
, pp. 278-284
-
-
Hulstaert, F.1
Neyt, M.2
Vinck, I.3
-
12
-
-
73949084847
-
The strength of study evidence examined by the FDA in pre-market approval of cardiovascular devices
-
Dhruva SS, Bero LA, Redberg RF. The strength of study evidence examined by the FDA in pre-market approval of cardiovascular devices. JAMA. 2009;302:2679-2685.
-
(2009)
JAMA
, vol.302
, pp. 2679-2685
-
-
Dhruva, S.S.1
Bero, L.A.2
Redberg, R.F.3
-
13
-
-
84868313703
-
Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval
-
Chen CE,Dhruva SS, Redberg RF. Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval. JAMA. 2012;308:1740-1742.
-
(2012)
JAMA
, vol.308
, pp. 1740-1742
-
-
Chen, C.E.1
Dhruva, S.S.2
Redberg, R.F.3
-
14
-
-
0035892018
-
Long-term mechanical left ventricular assistance for end-stage heart failure
-
Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. 2001;345:1435-1443.
-
(2001)
N Engl J Med.
, vol.345
, pp. 1435-1443
-
-
Rose, E.A.1
Gelijns, A.C.2
Moskowitz, A.J.3
-
15
-
-
84889578463
-
-
(accessed July 23, 2013) 16
-
National Coverage Determinations Manual. http://www.cms.gov/Regulations- and-Guidance/Guidance/Transmittals/downloads/R2NCD1. pdf (accessed July 23, 2013). 16.
-
National Coverage Determinations Manual
-
-
-
16
-
-
33747366081
-
Progress versus precision: Challenges in clinical trial design for left ventricular assist devices
-
Parides MK, Moskowitz AJ, Ascheim DD, Rose EA, Gelijns AC. Progress versus precision: Challenges in clinical trial design for left ventricular assist devices. Ann Thorac Surg. 2006;82:1140-1146.
-
(2006)
Ann Thorac Surg.
, vol.82
, pp. 1140-1146
-
-
Parides, M.K.1
Moskowitz, A.J.2
Ascheim, D.D.3
Rose, E.A.4
Gelijns, A.C.5
-
17
-
-
0012785515
-
-
National Institute for Health Care Management, (NIHCM) accessed July 23 2013
-
National Institute for Health Care Management, (NIHCM). Changing patterns of pharmaceutical innovation 2002. http://nihcm.org/pdf/innovations.pdf (accessed July 23, 2013).
-
(2002)
Changing Patterns of Pharmaceutical Innovation
-
-
-
18
-
-
2442613167
-
HeartMate VE LVAS design enhancements and its impact on device reliability
-
Dowling RD, Park SJ, Pagani FD, et al. HeartMate VE LVAS design enhancements and its impact on device reliability. Eur J Cardiothorac Surg. 2004;25:958-963.
-
(2004)
Eur J Cardiothorac Surg.
, vol.25
, pp. 958-963
-
-
Dowling, R.D.1
Park, S.J.2
Pagani, F.D.3
-
19
-
-
84855583224
-
Transcatheter aortic valve implantation.Assessing the learning curve
-
Alli OO, Booker JD, Lennon RJ, et al. Transcatheter aortic valve implantation. Assessing the learning curve. JACC Cardiovasc Interv. 2012;5:72-79.
-
(2012)
JACC Cardiovasc Interv.
, vol.5
, pp. 72-79
-
-
Alli, O.O.1
Booker, J.D.2
Lennon, R.J.3
-
20
-
-
84855704273
-
Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients. A glimpse into the future
-
Lange R, Bleiziffer S, Mazzitelli D, et al. Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients. A glimpse into the future. J Am Coll Cardiol. 2012;59:280-287.
-
(2012)
J Am Coll Cardiol.
, vol.59
, pp. 280-287
-
-
Lange, R.1
Bleiziffer, S.2
Mazzitelli, D.3
-
21
-
-
0035381974
-
Organizational differences in rates of learning: Evidence from the adoption of minimally invasive cardiac surgery
-
Pisano GP, Bohmer R, Edmondson AC. Organizational differences in rates of learning: Evidence from the adoption of minimally invasive cardiac surgery. Manage Sci. 2001;47:752-768.
-
(2001)
Manage Sci.
, vol.47
, pp. 752-768
-
-
Pisano, G.P.1
Bohmer, R.2
Edmondson, A.C.3
-
22
-
-
84881097166
-
Learning minimally invasive mitral valve surgery: A cumulative sum sequential probability analysis of 3895 operations from a single high-volume center
-
Holzhey DM, Seeburger J, Misfeld M, Borger MA, Mohr FW. Learning minimally invasive mitral valve surgery: A cumulative sum sequential probability analysis of 3895 operations from a single high-volume center. Circulation. 2013;128:483-491.
-
(2013)
Circulation
, vol.128
, pp. 483-491
-
-
Holzhey, D.M.1
Seeburger, J.2
Misfeld, M.3
Borger, M.A.4
Mohr, F.W.5
-
24
-
-
34548297997
-
Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: Implications for patient selection
-
Lietz K, Long JW, Kfoury AG, et al. Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: Implications for patient selection. Circulation. 2007;116:497-505.
-
Circulation
, vol.2007
, pp. 497-505
-
-
Lietz, K.1
Long, J.W.2
Kfoury, A.G.3
-
25
-
-
84872283890
-
Predicting survival in patients receiving continuous flow left ventricular assist devices: The HeartMate II risk score
-
Cowger J, Sundareswaran K, Rogers JG, et al. Predicting survival in patients receiving continuous flow left ventricular assist devices: The HeartMate II risk score. J Am Coll Cardiol. 2013;61:313-321.
-
(2013)
J Am Coll Cardiol.
, vol.61
, pp. 313-321
-
-
Cowger, J.1
Sundareswaran, K.2
Rogers, J.G.3
-
26
-
-
2642523534
-
HeartMate vented-electric left ventricular assist system: Technique for intrathoracic or intraperitoneal implantation via a left thoracotomy
-
Gregoric I, Wadia Y, Radovancevic B, et al. HeartMate vented-electric left ventricular assist system: Technique for intrathoracic or intraperitoneal implantation via a left thoracotomy. J Heart Lung Transplant. 2004;23:759-762.
-
(2004)
J Heart Lung Transplant
, vol.23
, pp. 759-762
-
-
Gregoric, I.1
Wadia, Y.2
Radovancevic, B.3
-
27
-
-
3242762197
-
Operative strategies to reduce complications in Novacor left ventricular assist device placement
-
Pasque MK, Hanselman T, Shelton K, Hedges R, Keohe-Huck B. Operative strategies to reduce complications in Novacor left ventricular assist device placement. J Card Surg. 2004;19:329-335.
-
(2004)
J Card Surg.
, vol.19
, pp. 329-335
-
-
Pasque, M.K.1
Hanselman, T.2
Shelton, K.3
Hedges, R.4
Keohe-Huck, B.5
-
28
-
-
11144276627
-
Nitric oxide inhalation modulates endothelin-1 plasma concentration gradients following left ventricular assist device implantation
-
Wagner F, Buz S, Neumeyer HH, Hetzer R, Hocher B, Nitric oxide inhalation modulates endothelin-1 plasma concentration gradients following left ventricular assist device implantation. J Cardiovasc Pharmacol. 2004;44(Suppl 1):S89-S91.
-
(2004)
J Cardiovasc Pharmacol
, vol.44
, Issue.SUPPL. 1
-
-
Wagner, F.1
Buz, S.2
Neumeyer, H.H.3
Hetzer, R.4
Hocher, B.5
-
29
-
-
25844505886
-
Nutrition assessment and management of left ventricular assist device patients
-
Holdy K, Dembitsky W, Eaton LL, et al. Nutrition assessment and management of left ventricular assist device patients. J Heart Lung Transplant. 2005;24:1690-1696.
-
(2005)
J Heart Lung Transplant.
, vol.24
, pp. 1690-1696
-
-
Holdy, K.1
Dembitsky, W.2
Eaton, L.L.3
-
30
-
-
11344252288
-
Perioperative pharmacotherapy in patients with left ventricular assist devices
-
Dang NC, Naka Y. Perioperative pharmacotherapy in patients with left ventricular assist devices. Drugs Aging. 2004;21:993-1012.
-
(2004)
Drugs Aging.
, vol.21
, pp. 993-1012
-
-
Dang, N.C.1
Naka, Y.2
-
31
-
-
0038312192
-
Infection in ventricular assist devices: Prevention and treatment
-
Holman WL, Rayburn BK, McGiffin DC, et al. Infection in ventricular assist devices: Prevention and treatment. Ann Thorac Surg. 2003;75(Suppl):S48- S57.
-
(2003)
Ann Thorac Surg.
, vol.75
, Issue.SUPPL.
-
-
Holman, W.L.1
Rayburn, B.K.2
McGiffin, D.C.3
-
32
-
-
0036162022
-
Successful use of activated recombinant factor VII to control bleeding abnormalities in a patient with a left ventricular assist device
-
Zietkiewicz M, GarlickiM, Domaga?a J, et al. Successful use of activated recombinant factor VII to control bleeding abnormalities in a patient with a left ventricular assist device. J Thorac Cardiovasc Surg. 2002;123:384-385.
-
(2002)
J Thorac Cardiovasc Surg.
, vol.123
, pp. 384-385
-
-
Zietkiewicz, M.1
Garlicki, M.2
Domagaa, J.3
-
33
-
-
33745484958
-
Hospital costs for left ventricular assist devices for destination therapy lower costs for implantation in the post-REMATCH era
-
Miller LW, Nelson KE, Bostic RR, et al. Hospital costs for left ventricular assist devices for destination therapy lower costs for implantation in the post-REMATCH era. J Heart Lung Transplant. 2006;25:778-784.
-
(2006)
J Heart Lung Transplant.
, vol.25
, pp. 778-784
-
-
Miller, L.W.1
Nelson, K.E.2
Bostic, R.R.3
-
34
-
-
33748751384
-
Improved mechanical reliability of the HeartMate XVE left ventricular assist system
-
Pagani FD, Long JW, Dembitsky WP, Joyce LD, Miller LW. Improved mechanical reliability of the HeartMate XVE left ventricular assist system. Ann Thorac Surg. 2006;82:1413-1418.
-
(2006)
Ann Thorac Surg.
, vol.82
, pp. 1413-1418
-
-
Pagani, F.D.1
Long, J.W.2
Dembitsky, W.P.3
Joyce, L.D.4
Miller, L.W.5
-
35
-
-
44649085549
-
Improving outcomes with long-term destination"therapy using left ventricular assist devices
-
Long JW, Healy AH, Rasmusson BY, et al. Improving outcomes with long-term "destination" therapy using left ventricular assist devices. J Thorac Cardiovasc Surg. 2008;135:1353-1360.
-
(2008)
J Thorac Cardiovasc Surg.
, vol.135
, pp. 1353-1360
-
-
Long, J.W.1
Healy, A.H.2
Rasmusson, B.Y.3
-
36
-
-
56049127755
-
Low incidence of neurologic events during long-term support with the Heart-Mate XVE left ventricular assist device
-
Slaughter MS, Sobieski MA, Gallagher C, Dia M, Silver MA. Low incidence of neurologic events during long-term support with the Heart-Mate XVE left ventricular assist device. Tex Heart Inst J. 2008;35:245-249.
-
(2008)
Tex Heart Inst J.
, vol.35
, pp. 245-249
-
-
Slaughter, M.S.1
Sobieski, M.A.2
Gallagher, C.3
Dia, M.4
Silver, M.A.5
-
37
-
-
28944449941
-
Cost effectiveness of cardiac resynchronization therapy in the Comparison ofMedical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial
-
Feldman AM, de Lissovoy G, Bristow MR, et al. Cost effectiveness of cardiac resynchronization therapy in the Comparison ofMedical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial. J Am Coll Cardiol. 2005;46:2311-2321.
-
(2005)
J Am Coll Cardiol.
, vol.46
, pp. 2311-2321
-
-
Feldman, A.M.1
De Lissovoy, G.2
Bristow, M.R.3
-
38
-
-
33846336156
-
The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator
-
Yao G, Freemantle N, Calvert MJ, et al. The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator. Eur Heart J. 2007;28:42-51.
-
(2007)
Eur Heart J.
, vol.28
, pp. 42-51
-
-
Yao, G.1
Freemantle, N.2
Calvert, M.J.3
-
39
-
-
67650093608
-
Extendedmechanical circulatory support with a continuous-flow rotary left ventricular assist device
-
Pagani FD,Miller LW, Russell SD, et al. Extendedmechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009;54:312-321.
-
(2009)
J Am Coll Cardiol.
, vol.54
, pp. 312-321
-
-
Pagani, F.D.1
Miller, L.W.2
Russell, S.D.3
-
40
-
-
79952749502
-
Clinical outcomes for continuous-flow left ventricular assist device patients stratified by preoperative INTERMACS classification
-
Boyle A, Teuteberg J, Ascheim DD, et al. Clinical outcomes for continuous-flow left ventricular assist device patients stratified by preoperative INTERMACS classification. J Heart Lung Transplant. 2011;30: 402-407.
-
(2011)
J Heart Lung Transplant.
, vol.30
, pp. 402-407
-
-
Boyle, A.1
Teuteberg, J.2
Ascheim, D.D.3
-
41
-
-
84872849457
-
Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients
-
Kirklin JK, Naftel DC, Kormos RL, et al. Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013;32:141-156.
-
(2013)
J Heart Lung Transplant.
, vol.32
, pp. 141-156
-
-
Kirklin, J.K.1
Naftel, D.C.2
Kormos, R.L.3
-
42
-
-
73349129701
-
HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device
-
Slaughter MS, Rogers JG, Milano CA, et al. HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251.
-
(2009)
N Engl J Med.
, vol.361
, pp. 2241-2251
-
-
Slaughter, M.S.1
Rogers, J.G.2
Milano, C.A.3
-
43
-
-
84860820973
-
Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy
-
Park SJ, Milano CA, Tatooles AJ, et al. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012;5:241-248.
-
(2012)
Circ Heart Fail.
, vol.5
, pp. 241-248
-
-
Park, S.J.1
Milano, C.A.2
Tatooles, A.J.3
-
44
-
-
70350455616
-
Innovation wiThexperience using implantable left ventricular assist devices
-
Ascheim DD, Gelijns AC, Rose EA. Innovation wiThexperience using implantable left ventricular assist devices. Circ Heart Fail. 2009;2:1-2.
-
(2009)
Circ Heart Fail.
, vol.2
, pp. 1-2
-
-
Ascheim, D.D.1
Gelijns, A.C.2
Rose, E.A.3
-
45
-
-
33749332084
-
Coverage options for promising technologies: Medicare's 'coverage wiThevidence development'
-
(Millwood)
-
Tunis SR, Pearson SD. Coverage options for promising technologies: Medicare's 'coverage wiThevidence development'. Health Aff (Millwood). 2006;25:1218-1230.
-
(2006)
Health Aff
, vol.25
, pp. 1218-1230
-
-
Tunis, S.R.1
Pearson, S.D.2
-
46
-
-
80053634402
-
NICE medical technology guidance: Devices and diagnostics
-
Campbell B. NICE medical technology guidance: Devices and diagnostics. Heart. 2011;97:1794-1795.
-
(2011)
Heart
, vol.97
, pp. 1794-1795
-
-
Campbell, B.1
-
47
-
-
79952815900
-
The NICE Medical Technologies Advisory Committee and medical technologies guidance
-
Campbell B. The NICE Medical Technologies Advisory Committee and medical technologies guidance. Heart. 2011;97:674-675.
-
(2011)
Heart
, vol.97
, pp. 674-675
-
-
Campbell, B.1
|