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Results: 1 to 20 of 30

1.

Cardiac resynchronization therapy in women: US Food and Drug Administration meta-analysis of patient-level data.

Zusterzeel R, Selzman KA, Sanders WE, Caños DA, O'Callaghan KM, Carpenter JL, Piña IL, Strauss DG.

JAMA Intern Med. 2014 Aug;174(8):1340-8. doi: 10.1001/jamainternmed.2014.2717.

PMID:
25090172
[PubMed - indexed for MEDLINE]
2.

Safety of computed tomography in patients with cardiac rhythm management devices: assessment of the U.S. Food and Drug Administration advisory in clinical practice.

Hussein AA, Abutaleb A, Jeudy J, Phelan T, Patel R, Shkullaku M, Siddiqi F, See V, Saliaris A, Shorofsky SR, Dickfeld T.

J Am Coll Cardiol. 2014 May 6;63(17):1769-75. doi: 10.1016/j.jacc.2013.12.040. Epub 2014 Feb 26.

PMID:
24583299
[PubMed - indexed for MEDLINE]
3.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

Rome BN, Kramer DB, Kesselheim AS.

JAMA. 2014 Jan 22-29;311(4):385-91. doi: 10.1001/jama.2013.284986.

PMID:
24449317
[PubMed - indexed for MEDLINE]
Free PMC Article
4.

Opening the FDA black box.

Goodman SN, Redberg RF.

JAMA. 2014 Jan 22-29;311(4):361-3. doi: 10.1001/jama.2013.283946. No abstract available.

PMID:
24449313
[PubMed - indexed for MEDLINE]
5.

The subcutaneous implantable cardioverter-defibrillator.

Grace A.

Curr Opin Cardiol. 2014 Jan;29(1):10-9. doi: 10.1097/HCO.0000000000000031. Review.

PMID:
24284982
[PubMed - indexed for MEDLINE]
6.

Health care policy and regulatory implications on medical device innovations: a cardiac rhythm medical device industry perspective.

Sharma A, Blank A, Patel P, Stein K.

J Interv Card Electrophysiol. 2013 Mar;36(2):107-17. doi: 10.1007/s10840-013-9781-y. Epub 2013 Mar 10. No abstract available.

PMID:
23474980
[PubMed - indexed for MEDLINE]
Free PMC Article
7.

FDA regulation of cardiovascular devices and opportunities for improvement.

Dhruva SS, Redberg RF.

J Interv Card Electrophysiol. 2013 Mar;36(2):99-105. doi: 10.1007/s10840-012-9767-1. Epub 2012 Dec 21.

PMID:
23263896
[PubMed - indexed for MEDLINE]
8.

An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance.

Laskey W, Awad K, Lum J, Skodacek K, Zimmerman B, Selzman K, Zuckerman B.

Am J Ther. 2012 Jul;19(4):248-54. doi: 10.1097/MJT.0b013e3182512ca5.

PMID:
22668602
[PubMed - indexed for MEDLINE]
9.

FDA approves first pacemaker system safe for magnetic resonance imaging. Traditional cardiac devices have been at risk of malfunctioning or overheating with MRIs.

[No authors listed]

Heart Advis. 2011 Apr;14(4):1, 11. No abstract available.

PMID:
22973585
[PubMed - indexed for MEDLINE]
10.

Cardiac resynchronization therapy for mild congestive heart failure.

[No authors listed]

Technol Eval Cent Assess Program Exec Summ. 2010 Apr;24(8):1-5. No abstract available.

PMID:
20575185
[PubMed - indexed for MEDLINE]
11.

FDA's perspectives on cardiovascular devices.

Chen EA, Patel-Raman SM, O'Callaghan K, Hillebrenner MG.

J Cardiovasc Transl Res. 2009 Jun;2(2):143-6. doi: 10.1007/s12265-009-9096-7. Epub 2009 Mar 10. Review.

PMID:
20559979
[PubMed - indexed for MEDLINE]
12.

A protocol for patients with cardiovascular implantable devices undergoing magnetic resonance imaging (MRI): should defibrillation threshold testing be performed post-(MRI).

Burke PT, Ghanbari H, Alexander PB, Shaw MK, Daccarett M, Machado C.

J Interv Card Electrophysiol. 2010 Jun;28(1):59-66. doi: 10.1007/s10840-009-9463-y. Epub 2010 Jan 29.

PMID:
20111895
[PubMed - indexed for MEDLINE]
13.

Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction.

Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM.

Europace. 2010 Mar;12(3):395-401. doi: 10.1093/europace/eup375. Epub 2009 Nov 27.

PMID:
19946113
[PubMed - indexed for MEDLINE]
Free PMC Article
14.

Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review.

McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH.

JAMA. 2007 Jun 13;297(22):2502-14. Review.

PMID:
17565085
[PubMed - indexed for MEDLINE]
15.

Initial United States experience with the Paracor HeartNet myocardial constraint device for heart failure.

Klodell CT Jr, McGiffin DC, Rayburn BK, Sun B, Abraham WT, Conte JV, Russell SD, Pae WE Jr, Boehmer JP, Aranda JM Jr.

J Thorac Cardiovasc Surg. 2007 Jan;133(1):204-9. Epub 2006 Dec 5.

PMID:
17198812
[PubMed - indexed for MEDLINE]
16.

Food and Drug Administration perspective: Magnetic resonance imaging of pacemaker and implantable cardioverter-defibrillator patients.

Faris OP, Shein M.

Circulation. 2006 Sep 19;114(12):1232-3. No abstract available.

PMID:
16982951
[PubMed - indexed for MEDLINE]
Free Article
17.

Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla.

Nazarian S, Roguin A, Zviman MM, Lardo AC, Dickfeld TL, Calkins H, Weiss RG, Berger RD, Bluemke DA, Halperin HR.

Circulation. 2006 Sep 19;114(12):1277-84. Epub 2006 Sep 11.

PMID:
16966586
[PubMed - indexed for MEDLINE]
Free PMC Article
18.

Life-threatening malfunction of implantable cardiac devices.

Myerburg RJ, Feigal DW Jr, Lindsay BD.

N Engl J Med. 2006 Jun 1;354(22):2309-11. Epub 2006 May 15. No abstract available.

PMID:
16702187
[PubMed - indexed for MEDLINE]
19.

Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports.

Maisel WH, Moynahan M, Zuckerman BD, Gross TP, Tovar OH, Tillman DB, Schultz DB.

JAMA. 2006 Apr 26;295(16):1901-6.

PMID:
16639048
[PubMed - indexed for MEDLINE]
20.

Postmortem analysis and retrieval of implantable pacemakers and defibrillators.

Kirkpatrick JN, Burke MC, Knight BP.

N Engl J Med. 2006 Apr 13;354(15):1649-50. No abstract available.

PMID:
16611964
[PubMed - indexed for MEDLINE]
Free Article

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