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Clinical evidence guidelines: Medical devices

24 February 2017

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Appendix 4: References

  1. For example, medical devices may be exempt from inclusion on the ARTG under Parts 4-6A and 4-7 of the Therapeutic Goods Act 1989, and under Part 7 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002;;;

  2. Australian Regulatory Guidelines for Medical Devices:
  3. Therapeutic Goods Act 1989:
  4. Therapeutic Goods Act 1989, Chapter 4 - Medical Devices:
  5. Therapeutic Goods (Medical Devices) Regulations 2002:
  6. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2 - Classification rules for medical devices other than IVD medical devices:
  7. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2A - Classification rules for IVD medical devices:
  8. TGA guidance - Classification of IVD medical devices:
  9. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 1
  10. Therapeutic Goods Act 1989, section 41FN
  11. Therapeutic Goods Act 1989, section 41JA
  12. MD Regulation 3.11(2) requires that the clinical evaluation procedures outlined in Schedule 3 Part 8 need to be applied to all medical devices, with narrow exceptions for some devices exempt from inclusion in the ARTG (such as devices imported for personal use) or those devices approved for special or experimental purposes (under Act s.41HB) or under authorised prescriber arrangements (s.41HC).;
  13. Therapeutic Goods (Medical Devices) Regulations 2002, Part 8 - Clinical evaluation procedures:
  14. MD Regulation 3.11(1)
  15. Essential Principle 4 - Long term safety:
  16. Essential Principles 13.3 (Information to be provided with medical devices - particular requirements) and 13.4 (Instructions for use):
  17. Paragraph 41BD(2) of the Therapeutic Goods Act 1989:
  18. Further reading on balancing risk and benefit is included in FDA, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, 2016.
  19. Items 3 and 4 of Essential Principle 13.4.(3):
  20. Item 19 of Essential Principle 13.4:
  21. Items 5 of Essential Principles 13.3 and 13.4.(3):
  22. Item 4 of Essential Principle 13.3 and item 7 of Essential Principle 13.4(3):
  23. Item 26 of Essential Principle 13.4.(3):
  24. ISO Standard 13485: Medical devices - Quality management systems - Requirements for regulatory purposes 2011:
  25. ISO Standard 14155: Clinical investigation of medical devices for human subjects - Good clinical practice 2011.
  26. ISO Standard 14971: Application of risk management to medical devices.
  27. ISO 9001 is a series of standards that define, establish, and maintain a quality assurance system for manufacturing and service industries. The emphasis of ISO13485 is different, i.e., focussed on meeting national regulations rather than promoting continuous improvement and customer satisfaction.
  28. MEDDEV 2.7/1 revision 4 - Clinical evaluation: Guide for manufacturers and notified bodies
  29. Conformity Assessment Standards Order (standard for quality management systems and quality assurance techniques) 2008:
  30. World Medical Association, Declaration of Helsinki, 2013.
  31. ISO Standard 11979-7: Ophthalmic implants - Intraocular lenses 2014 - Clinical Investigations:
  32. ISO Standard 5840: Cardiovascular implants - Cardiac valve prostheses, 2015:
  33. ISO/TS 10974: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device, International Organization for Standardization (2012).
  34. GHTF document, Clinical Evidence - Key Definitions and Concepts, SG5/N1R8:2007
  35. The manufacturer must ensure that the clinical data is evaluated by competent clinical experts under MD Regulations Schedule 3 Part 8 Clause 8.6 (1) and (2)
  36. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 8, Item 8.4 (4) and (5)
  37. National Statement on ethical conduct in human research (2007) - Updated May 2015:
  38. Note for guidance on good clinical practice (CHMP/ICH/135/95):
  39. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 8, Item 8.4 (5)
  40. For further details on ICMJE clinical trial registration requirements see:
  41. For further details on the WHO International Clinical Trials Registry Platform see:
  42. For further details on ANZCTR see:
  43. For further details on clinical trials see:
  44. Consolidated Standards of Reporting Trials (CONSORT):
  45. Strengthening the reporting of observational studies in epidemiology:
  46. Standards for the Reporting of Diagnostic Accuracy Studies (STARD):
  47. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA):
  48. Meta-analysis of Observational Studies in Epidemiology (MOOSE) Guidelines -
  49. Literature reviews are required under the MD Regulations Schedule 3 Part 8 Clause 8.3 and 8.5.
  50. Database of Adverse Event Notifications (DAEN) - medical devices:
  51. System for Australian Recall Actions (SARA):
  52. Australian Breast Device Registry (ABDR):
  53. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR):
  54. Victorian Cardiac Outcomes Registry (VCOR):
  55. PubMed:
  56. Scottish Intercollegiate Guidelines Network (SIGN) - Critical appraisal: Notes and checklists:
  57. Centre for evidence-based medicine - Critical appraisal tools:
  58. Cochrane Handbook for Systematic Reviews of Interventions:
  59. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines:
  60. GHTF document, Clinical Evaluation SG5/N2R8:2007 Appendix E: A Possible Format for a Clinical Evaluation Report
  61. The manufacturer must ensure that the clinical data is evaluated by competent clinical experts under MD Regulations Schedule 3 Part 8 Clause 8.6 (1) and (2)
  62. FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (Feb 2016), page 5
  63. ISO Standard 14971:2007: Medical devices - Application of risk management to medical devices:
  64. GHTF document, Clinical Evaluation SG5/N2R8:2007
  65. Therapeutic Goods (Medical Devices) Regulations 2002 - Dictionary:
  66. GHTF document, Clinical Evaluation SG5/N2R8:2007, page 8
  67. Medical Device Directive 2.4/1 Revision 9 (June 2010) Classification of Medical Devices Guidance Document, available at:
  68. Therapeutic Goods Act 1989 - Section 41MP - Criminal offence for failing to notify adverse events etc.:
  69. National Joint Registry UK. Patient introduction to the NJR. 2014 [cited 11 July 2014];
  70. Australian Orthopaedic Association. Hip and Knee Arthroplasty, Annual report 2013; 2013
  71. Murray DW, MacLennan GS, Breeman S et al. A randomised controlled trial of the clinical effectiveness and cost-effectiveness of different knee prostheses: the Knee Arthroplasty Trial (KAT). Health Technol Assess. 2014;18:1-235, vii-viii
  72. Litchfield RB, McKee MD, Balyk R et al. Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for osteoarthritis of the shoulder: a prospective, randomized, double-blind clinical trial-A JOINTs Canada Project. J Shoulder Elbow Surg. 2011;20:529-36.
  73. TGA website - Clinical Trials:
  74. United States Food and Drug Administration - Clinical Trials and Human Subject Protection:
  75. Providing yearly figures allows the estimation of cumulative percent incidence, or incidence as a fraction of observation years. It is good practice for the Manufacturer to perform these calculations on a regular basis. For implants such as orthopaedics, Kaplan Meyer analysis is preferred. This sort of analysis is often performed with revision surgery (i.e. % requiring revision at 1, 2, 3, .., n years from the time of primary surgery as an end point, but it can also be performed on many other endpoints.
  76. Migliore A, Perrini MR, Romanini E et al. Comparison of the performance of hip implants with data from different arthroplasty registers. J Bone Joint Surg Br. 2009;91:1545-9
  77. Goldberg VM, Buckwalter J, Halpin M et al. Recommendations of the OARSI FDA Osteoarthritis Devices Working Group. Osteoarthritis Cartilage. 2011;19:509-14.
  78. de Steiger RN, Miller LN, Davidson DC, Ryan P, Graves SE. Joint registry approach for identification of outlier prostheses. Acta Orthop. 2013;84:348-52.
  79. Pijls BG, Nieuwenhuijse MJ, Schoones JW, Middeldorp S, Valstar ER, Nelissen RG. RSA prediction of high failure rate for the uncoated Interax TKA confirmed by meta-analysis. Acta Orthop. 2012;83:142-7
  80. Pijls BG, Nieuwenhuijse MJ, Fiocco M et al. Early proximal migration of cups is associated with late revision in THA: a systematic review and meta-analysis of 26 RSA studies and 49 survival studies. Acta Orthop. 2012;83:583-91
  81. Hartmann A, Hannemann F, Lutzner J et al. Metal ion concentrations in body fluids after implantation of hip replacements with metal-on-metal bearing--systematic review of clinical and epidemiological studies. PLoS One. 2013;8:e70359
  82. Ng CY, Ballantyne JA, Brenkel IJ. Quality of life and functional outcome after primary total hip replacement. A five-year follow-up. J Bone Joint Surg Br. 2007;89:868-73
  83. Voleti PB, Baldwin KD, Lee GC. Metal-on-metal vs conventional total hip arthroplasty: a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty. 2012;27:1844-9.
  84. Kynaston-Pearson F, Ashmore AM, Malak TT et al. Primary hip replacement prostheses and their evidence base: systematic review of literature. BMJ (Clinical research ed). 2013;347:f6956.
  85. Marshall DA, Pykerman K, Werle J et al. Hip Resurfacing versus Total Hip Arthroplasty: A Systematic Review Comparing Standardized Outcomes. Clin Orthop Relat Res. 2014;472:2217-30.
  86. Chen K, Li G, Fu D, Yuan C, Zhang Q, Cai Z. Patellar resurfacing versus nonresurfacing in total knee arthroplasty: a meta-analysis of randomised controlled trials. Int Orthop. 2013;37:1075-83.
  87. Zeng Y, Shen B, Yang J, Zhou ZK, Kang PD, Pei FX. Is there reduced polyethylene wear and longer survival when using a mobile-bearing design in total knee replacement? A meta-analysis of randomised and non-randomised controlled trials. Bone Joint J. 2013;95-b(8):1057-63.
  88. Nouta KA, Verra WC, Pijls BG, Schoones JW, Nelissen RG. All-polyethylene tibial components are equal to metal-backed components: systematic review and meta-regression. Clin Orthop Relat Res. 2012;470:3549-59.
  89. Arnold JB, Walters JL, Solomon LB, Thewlis D. Does the method of component fixation influence clinical outcomes after total knee replacement? A systematic literature review. J Arthroplasty. 2013;28:740-6.
  90. Nakama GY, Peccin MS, Almeida GJ, Lira Neto Ode A, Queiroz AA, Navarro RD. Cemented, cementless or hybrid fixation options in total knee arthroplasty for osteoarthritis and other non-traumatic diseases. Cochrane Database Syst Rev. 2012;10:Cd006193.
  91. Inacio MC, Cafri G, Paxton EW, Kurtz SM, Namba RS. Alternative bearings in total knee arthroplasty: risk of early revision compared to traditional bearings: an analysis of 62,177 primary cases. Acta Orthop. 2013;84:145-52.
  92. Kärrholm J, Steen K, Hultenheim Klintberg I, Ekholm C, Svanberg T, Samuelsson O. Prosthetic arthroplasty in primary shoulder osteoarthritis. Göteborg: Västra Götalandsregionen, Sahlgrenska Universitetssjukhuset, HTA-centrum; 2012. Regional activity-based HTA 2012:52; 2012.
  93. Singh JA, Sperling J, Buchbinder R, McMaken K. Surgery for shoulder osteoarthritis. Cochrane Database Syst Rev. 2010(10).
  94. Rasmussen JV, Polk A, Sorensen AK, Olsen BS, Brorson S. Outcome, revision rate and indication for revision following resurfacing hemiarthroplasty for osteoarthritis of the shoulder: 837 operations reported to the Danish Shoulder Arthroplasty Registry. Bone Joint J. 2014;96-B(4):519-25.
  95. Fevang BT, Lygre SH, Bertelsen G, Skredderstuen A, Havelin LI, Furnes O. Pain and function in eight hundred and fifty nine patients comparing shoulder hemiprostheses, resurfacing prostheses, reversed total and conventional total prostheses. Int Orthop. 2013;37:59-66.
  96. NICE. Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the hip; 2014.
  97. Clement ND, Macdonald D, Simpson AH. The minimal clinically important difference in the Oxford knee score and Short Form 12 score after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 pp -
  98. Keurentjes JC, Van Tol FR, Fiocco M, Schoones JW, Nelissen RG. Minimal clinically important differences in health-related quality of life after total hip or knee replacement: A systematic review. Bone and joint research. 2012;1:71-7
  99. Escobar A, Quintana JM, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage. 2007;15:273-80
  100. Judge A, Arden NK, Kiran A et al. Interpretation of patient-reported outcomes for hip and knee replacement surgery: identification of thresholds associated with satisfaction with surgery. J Bone Joint Surg Br. 2012;94:412-8.
  101. NICE. Interventional procedure overview of carotid artery stent placement for symptomatic extracranial carotid stenosis. 2010:IP 008_2.
  102. Canadian Agency of Drugs and Technologies in Health (CADTH). Carotid artery stenting versus carotid endoarterrectormy, a review of the clinical and cost-effectiveness. Health Technology Inquiry Service 2010 [cited December 2014];
  103. Raman G, Kitsios GD, Moorthy D et al. AHRQ Technology Assessments. Management of Asymptomatic Carotid Stenosis. Rockville (MD): Agency for Healthcare Research and Quality (US) 2012.
  104. Chen Z, Chen L, Wu L. Transcatheter amplatzer occlusion and surgical closure of patent ductus arteriosus: comparison of effectiveness and costs in a low-income country. Pediatr Cardiol. 2009;30(6):781-5.
  105. Wang K, Pan X, Tang Q, Pang Y. Catheterization therapy vs. surgical closure in pediatric patients with patent ductus arteriosus: a meta-analysis. Clin Cardiol. 2014;37(3):188-94.
  106. Boehm W, Emmel M, Sreeram N. The Amplatzer duct occluder for PDA closure: indications, technique of implantation and clinical outcome. Images Paediatr Cardiol. 2007;9(2):16-26.
  107. Huang TC, Chien KJ, Hsieh KS, Lin CC, Lee CL. Comparison of 0.052-inch coils vs. amplatzer duct occluder for transcatheter closure of moderate to large patent ductus arteriosus. Circ J. 2009;73(2):356-60.
  108. Young T, Tang H, Hughes R. Vena caval filters for the prevention of pulmonary embolism. Cochrane database of systematic reviews (Online). 2010(2):CD006212.
  109. Brott TG, Hobson RW, 2nd, Howard G et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363(1):11-23
  110. Cutlip DE, Windecker S, Mehran R et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344-51.
  111. European Commision - Directives on medical devices. Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies. 2008.
  112. Kip KE, Hollabaugh K, Marroquin OC, Williams DO. The problem with composite end points in cardiovascular studies: the story of major adverse cardiac events and percutaneous coronary intervention. J Am Coll Cardiol. 2008;51(7):701-7.
  113. O'Brien M, Chandra A. Carotid revascularization: risks and benefits. Vasc Health Risk Manag. 2014;10:403-16.
  114. Schillinger M, Minar E. Percutaneous treatment of peripheral artery disease: novel techniques. Circulation. 2012;126(20):2433-40.
  115. Kudagi VS, White CJ. Endovascular stents: a review of their use in peripheral arterial disease. Am J Cardiovasc Drugs. 2013;13(3):199-212.
  116. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5-67.
  117. Chaikof EL, Blankensteijn JD, Harris PL et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35(5):1048-60.
  118. Brunetti MA, Ringel R, Owada C et al. Percutaneous closure of patent ductus arteriosus: a multiinstitutional registry comparing multiple devices. Catheter Cardiovasc Interv. 2010;76(5):696-702.
  119. El-Said HG, Bratincsak A, Foerster SR et al. Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience. J Am Heart Assoc. 2013;2(6):e000424.
  120. Uberoi R, Tapping CR, Chalmers N, Allgar V. British Society of Interventional Radiology (BSIR) Inferior Vena Cava (IVC) Filter Registry. Cardiovasc Intervent Radiol. 2013;36(6):1548-61.
  121. Meier P, Knapp G, Tamhane U, Chaturvedi S, Gurm HS. Short term and intermediate term comparison of endarterectomy versus stenting for carotid artery stenosis: systematic review and meta-analysis of randomised controlled clinical trials. BMJ. 2010;340:c467.
  122. Bonati LH, Lyrer P, Ederle J, Featherstone R, Brown MM. Percutaneous transluminal balloon angioplasty and stenting for carotid artery stenosis. Cochrane Database Syst Rev. 2012;9:Cd000515.
  123. Liu ZJ, Fu WG, Guo ZY, Shen LG, Shi ZY, Li JH. Updated systematic review and meta-analysis of randomized clinical trials comparing carotid artery stenting and carotid endarterectomy in the treatment of carotid stenosis. Ann Vasc Surg. 2012;26(4):576-90.
  124. Al-Damluji MS, Nagpal S, Stilp E, Remetz M, Mena C. Carotid revascularization: a systematic review of the evidence. J Interv Cardiol. 2013;26(4):399-410.
  125. Gahremanpour A, Perin EC, Silva G. Carotid artery stenting versus endarterectomy: a systematic review. Tex Heart Inst J. 2012;39(4):474-87
  126. Piccolo R, Cassese S, Galasso G, De Rosa R, D'Anna C, Piscione F. Long-term safety and efficacy of drug-eluting stents in patients with acute myocardial infarction: a meta-analysis of randomized trials. Atherosclerosis. 2011;217(1):149-57.
  127. De Luca G, Dirksen MT, Spaulding C et al. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012;172(8):611-21; discussion 21-2.
  128. Wallace EL, Abdel-Latif A, Charnigo R et al. Meta-analysis of long-term outcomes for drug-eluting stents versus bare-metal stents in primary percutaneous coronary interventions for ST-segment elevation myocardial infarction. Am J Cardiol. 2012;109(7):932-40.
  129. Bangalore S, Amoroso N, Fusaro M, Kumar S, Feit F. Outcomes with various drug-eluting or bare metal stents in patients with ST-segment-elevation myocardial infarction: a mixed treatment comparison analysis of trial level data from 34 068 patient-years of follow-up from randomized trials. Circ Cardiovasc Interv. 2013;6(4):378-90.
  130. Palmerini T, Biondi-Zoccai G, Della Riva D et al. Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2013;62(6):496-504.
  131. Kalesan B, Pilgrim T, Heinimann K et al. Comparison of drug-eluting stents with bare metal stents in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012;33(8):977-87.
  132. Medical Advisory Secretariat. Stenting for peripheral artery disease of the lower extremities: an evidence based analysis. Ont Health Technol Assess Ser [Internet]. 10(18)
  133. Acin F, de Haro J, Bleda S, Varela C, Esparza L. Primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis of randomized controlled trials. J Endovasc Ther. 2012;19(5):585-95
  134. Chambers D, Epstein D, Walker S et al. Endovascular stents for abdominal aortic aneurysms: a systematic review and economic model. Health Technol Assess. 2009;13(48):1-189, 215-318, iii.
  135. Simpson EL, Kearns B, Stevenson MD, Cantrell AJ, Littlewood C, Michaels JA. Enhancements to angioplasty for peripheral arterial occlusive disease: systematic review, cost-effectiveness assessment and expected value of information analysis. Health Technol Assess. 2014;18(10):1-252.
  136. Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014;6:Cd006767.
  137. Stather PW, Sidloff D, Dattani N, Choke E, Bown MJ, Sayers RD. Systematic review and meta-analysis of the early and late outcomes of open and endovascular repair of abdominal aortic aneurysm. Br J Surg. 2013;100(7):863-72.
  138. Paravastu SC, Jayarajasingam R, Cottam R, Palfreyman SJ, Michaels JA, Thomas SM. Endovascular repair of abdominal aortic aneurysm. Cochrane Database Syst Rev. 2014;1:Cd004178.
  139. van Beek SC, Conijn AP, Koelemay MJ, Balm R. Editor's Choice - Endovascular aneurysm repair versus open repair for patients with a ruptured abdominal aortic aneurysm: a systematic review and meta-analysis of short-term survival. Eur J Vasc Endovasc Surg. 2014;47(6):593-602.
  140. Edwards ST, Schermerhorn ML, O'Malley AJ et al. Comparative effectiveness of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Medicare population. J Vasc Surg. 2014;59(3):575-82.
  141. Haut ER, Garcia LJ, Shihab HM et al. The effectiveness of prophylactic inferior vena cava filters in trauma patients: a systematic review and meta-analysis. JAMA Surg. 2014;149(2):194-202.
  142. Sharifi M, Bay C, Skrocki L, Lawson D, Mazdeh S. Role of IVC filters in endovenous therapy for deep venous thrombosis: the FILTER-PEVI (filter implantation to lower thromboembolic risk in percutaneous endovenous intervention) trial. Cardiovasc Intervent Radiol. 2012;35(6):1408-13.
  143. Coffey RJ, Lozano AM. Neurostimulation for chronic noncancer pain: An evaluation of the clinical evidence and recommendations for future trial designs. J Neurosurg. 2006;105(2):175-89
  144. US Food & Drug Administration (FDA). Guidance for the submission of research and marketing applications for permanent pacemaker leads and for pacemaker lead adaptor 510(k) submissions; 2000
  145. Coma Samartin R, Cano Perez O, Pombo Jimenez M. Spanish Pacemaker Registry. Eleventh official report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2013). Rev Esp Cardiol. 2014;67(12):1024-38.
  146. Moller M, Arnsbo P. [The Danish Pacemaker Registry. A database for quality assurance]. Ugeskr Laeger. 1996;158(23):3311-5.
  147. Gadler F, Valzania C, Linde C. Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry. Europace. 2015;17(1):69-77.
  148. Mouillet G, Lellouche N, Yamamoto M et al. Outcomes following pacemaker implantation after transcatheter aortic valve implantation with CoreValve devices: Results from the FRANCE 2 Registry. Catheter Cardiovasc Interv. 2015.
  149. Benkemoun H, Sacrez J, Lagrange P et al. Optimizing pacemaker longevity with pacing mode and settings programming: Results from a pacemaker multicenter registry. Pacing Clin Electrophysiol. 2012;35(4):403-8.
  150. Proclemer A, Zecchin M, D'Onofrio A et al. [The pacemaker and implantable cardioverter-defibrillator registry of the Italian Association Arrhythmology Cardiac Pacing and cardiac pacing - annual report 2013]. G Ital Cardiol (Rome). 2014;15(11):638-50.
  151. Chen KP, Dai Y, Hua W et al. Reduction of atrial fibrillation in remotely monitored pacemaker patients: results from a Chinese multicentre registry. Chin Med J. 2013;126(22):4216-21.
  152. Markewitz A. [Annual Report 2009 of the German Cardiac Pacemaker Registry: Federal Section pacemaker and AQUA - Institute for Applied Quality Improvement and Research in Health Ltd]. Herzschrittmacherther Elektrophysiol. 2011;22(4):259-80.
  153. Przybylski A, Derejko P, Kwasniewski W et al. Bleeding complications after pacemaker or cardioverter-defibrillator implantation in patients receiving dual antiplatelet therapy: Results of a prospective, two-centre registry. Neth Heart J. 2010;18(5):230-5.
  154. Poole JE, Gleva MJ, Mela T et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010;122(16):1553-61.
  155. Reid CM, Brennan AL, Dinh DT et al. Measuring safety and quality to improve clinical outcomes--current activities and future directions for the Australian Cardiac Procedures Registry. Med J Aust. 2010;193(8 Suppl):S107-10.
  156. Nielsen JC, Thomsen PE, Hojberg S et al. A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome. Eur Heart J. 2011;32(6):686-96
  157. ISO Standard 14117:2012 - Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices:
  158. Crossley GH, Poole JE, Rozner MA et al. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: Facilities and patient management: Executive summary this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011;8(7):e1-18.
  159. Castelnuovo E, Stein K, Pitt M, Garside R, Payne E. The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: Systematic review and economic evaluation. Health Technol Assess. 2005;9(43):iii, xi-xiii, 1-246.
  160. Kong MH, Al-Khatib SM, Sanders GD, Hasselblad V, Peterson ED. Use of implantable cardioverter-defibrillators for primary prevention in older patients: A systematic literature review and meta-analysis. Cardiol J. 2011;18(5):503-14
  161. Colquitt JL, Mendes D, Clegg AJ et al. Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: Systematic review and economic evaluation. Health Technol Assess. 2014;18(56):1-560
  162. Chen S, Ling Z, Kiuchi MG, Yin Y, Krucoff MW. The efficacy and safety of cardiac resynchronization therapy combined with implantable cardioverter defibrillator for heart failure: A meta-analysis of 5674 patients. Europace. 2013;15(7):992-1001
  163. Chen S, Yin Y, Krucoff MW. Effect of cardiac resynchronization therapy and implantable cardioverter defibrillator on quality of life in patients with heart failure: A meta-analysis. Europace. 2012;14(11):1602-7
  164. Pun PH, Al-Khatib SM, Han JY et al. Implantable cardioverter-defibrillators for primary prevention of sudden cardiac death in CKD: A meta-analysis of patient-level data from 3 randomized trials. American Journal of Kidney Disease. 2014;64(1):32-9
  165. Schinkel AF. Implantable cardioverter defibrillators in arrhythmogenic right ventricular dysplasia/cardiomyopathy: patient outcomes, incidence of appropriate and inappropriate interventions, and complications. Circulation: Arrhythmia and Electrophysiology. 2013;6(3):562-8
  166. Health Canada. Guidance Document: Medical Device Applications for Implantable Cardiac Leads. File No. 11-113340-236; 2011
  167. American Heart Association - Classes of Heart Failure - New York Heart Association Functional Classification system:
  168. Plow EB, Pascual-Leone A, Machado A. Brain stimulation in the treatment of chronic neuropathic and non-cancerous pain. The Journal of Pain. 2012;13(5):411-24
  169. Taylor RS, Van Buyten JP, Buchser E. Spinal cord stimulation for complex regional pain syndrome: A systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors. European Journal of Pain. 2006;10(2):91-101
  170. Fontaine D, Hamani C, Lozano A. Efficacy and safety of motor cortex stimulation for chronic neuropathic pain: Critical review of the literature. J Neurosurg. 2009;110(2):251-6
  171. Simpson EL, Duenas A, Holmes MW, Papaioannou D, Chilcott J. Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin: Systematic review and economic evaluation. Health Technol Assess. 2009;13(17):iii, ix-x, 1-154
  172. Looi KL, Gajendragadkar PR, Khan FZ et al. Cardiac resynchronisation therapy: pacemaker versus internal cardioverter-defibrillator in patients with impaired left ventricular function. Heart. 2014;100(10):794-9.
  173. Kappetein AP, Head SJ, Genereux P et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012;33(19):2403-18.
  174. Williams JW, Coeytaux R, Wang A, Glower DD. Percutaneous Heart Valve Replacment. Technical Brief No. 2. . Rockville, MD: Prepared by Duke Evidence-based Practice Center under Contract No. 290-02-0025. Agency for Healthcare Research and Quality; 2010.
  175. ASERNIPS. Sutureless aortic valve replacement in patients with severe aortic stenosis. 2012 [cited 2015 February 10th];
  176. ISO Standard 5840-1:2015: Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements:
  177. ISO Standard 5840-2:2015: Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes:
  178. ISO Standard 5840-3:2013: Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques:
  179. Avanzas P, Munoz-Garcia AJ, Segura J et al. Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63(2):141-8
  180. Buellesfeld L, Gerckens U, Schuler G et al. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol. 2011;57(16):1650-7
  181. Eltchaninoff H, Prat A, Gilard M et al. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011;32(2):191-7
  182. Godino C, Maisano F, Montorfano M et al. Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience. JACC Cardiovasc Interv. 2010;3(11):1110-21
  183. Haussig S, Schuler G, Linke A. Worldwide TAVI registries: What have we learned? Clin Res Cardiol. 2014;103(8):603-12
  184. Moat NE, Ludman P, de Belder MA et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011;58(20):2130-8
  185. Moynagh AM, Scott DJ, Baumbach A et al. CoreValve transcatheter aortic valve implantation via the subclavian artery: comparison with the transfemoral approach. J Am Coll Cardiol. 2011;57(5):634-5
  186. Tamburino C, Capodanno D, Ramondo A et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123(3):299-308
  187. Thomas M, Schymik G, Walther T et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011;124(4):425-33
  188. Thomas M, Schymik G, Walther T et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010;122(1):62-9
  189. Walters DL, Sinhal A, Baron D et al. Initial experience with the balloon expandable Edwards-SAPIEN Transcatheter Heart Valve in Australia and New Zealand: the SOURCE ANZ registry: outcomes at 30 days and one year. Int J Cardiol. 2014;170(3):406-12
  190. Zahn R, Gerckens U, Grube E et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32(2):198-204
  191. Akins CW, Miller DC, Turina MI et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. Ann Thorac Surg. 2008;85(4):1490-5
  192. European Journal of Cardio-Thoracic Surgery 42 (2012) S45-S60 - Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document:
  193. Leon MB, Piazza N, Nikolsky E et al. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011;57(3):253-69
  194. Zamorano JL, Badano LP, Bruce C et al. EAE/ASE recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. J Am Soc Echocardiogr. 2011;24(9):937-65
  195. Zoghbi WA, Chambers JB, Dumesnil JG et al. Recommendations for Evaluation of Prosthetic Valves With Echocardiography and Doppler Ultrasound. A Report From the American Society of Echocardiography's Guidelines and Standards Committee and the Task Force on Prosthetic Valves, Developed in Conjunction With the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association. J Am Soc Echocardiogr. 2009;22(9):975-1014
  196. Wu Y, Butchart EG, Borer JS, Yoganathan A, Grunkemeier GL. Clinical Evaluation of New Heart Valve Prostheses: Update of Objective Performance Criteria. Ann Thorac Surg. 2014
  197. Kassai B, Gueyffier F, Cucherat M, Boissel JP. Comparison of bioprosthesis and mechanical valves, a meta-analysis of randomised clinical trials. Cardiovasc Surg. 2000;8(6):477-83
  198. Kunadian B, Vijayalakshmi K, Thornley AR et al. Meta-analysis of valve hemodynamics and left ventricular mass regression for stentless versus stented aortic valves. Ann Thorac Surg. 2007;84(1):73-8
  199. Lund O, Bland M. Risk-corrected impact of mechanical versus bioprosthetic valves on long-term mortality after aortic valve replacement. J Thorac Cardiovasc Surg. 2006;132(1):20-6.e3
  200. Puvimanasinghe JP, Takkenberg JJ, Edwards MB et al. Comparison of outcomes after aortic valve replacement with a mechanical valve or a bioprosthesis using microsimulation. Heart. 2004;90(10):1172-8
  201. Puvimanasinghe JP, Takkenberg JJ, Eijkemans MJ et al. Choice of a mechanical valve or a bioprosthesis for AVR: does CABG matter? Eur J Cardiothorac Surg. 2003;23(5):688-95; discussion 95
  202. Puvimanasinghe JP, Takkenberg JJ, Eijkemans MJ et al. Comparison of Carpentier-Edwards pericardial and supraannular bioprostheses in aortic valve replacement. Eur J Cardiothorac Surg. 2006;29(3):374-9
  203. Rizzoli G, Vendramin I, Nesseris G, Bottio T, Guglielmi C, Schiavon L. Biological or mechanical prostheses in tricuspid position? A meta-analysis of intra-institutional results. Ann Thorac Surg. 2004;77(5):1607-14
  204. National Institute for Health and Clinical Excellence. Interventional procedure overview of transcatheter aortic valve implantation for aortic stenosis.: National Institute for Health and Clinical Excellence; 2011
  205. Tice JA, Sellke FW, Schaff HV. Transcatheter aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical complications: Summary assessment of the California Technology Assessment Forum. J Thorac Cardiovasc Surg. 2014;148(2):482-91.e6
  206. National Institute for Health and Clinical Excellence. Interventional procedure overview of sutureless aortic valve replacement for aortic stenosis. ; 2012. Report No.: IPG456
  207. Sinclair A, Xie X, McGregor M. Surgical aortic valve replacement with the ATS Enable sutureless aortic valve for aortic stenosis. Montreal, Canada: Technology Assessment Unit (TAU) of the McGill University Health Centre (MUHC); 2013
  208. Englberger L, Carrel TP, Doss M et al. Clinical performance of a sutureless aortic bioprosthesis: Five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014;148(4):1681-7
  209. Food and Drug Administration. Surgical Mesh: FDA Safety Communication. 2012 [cited;]
  210. Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification system (POP-Q) - a new era in pelvic prolapse staging. Journal of Medicine and Life. 2011;4(1):75-81.
  211. Furnee E, Hazebroek E. Mesh in laparoscopic large hiatal hernia repair: a systematic review of the literature. Surgical Endoscopy. 2013;27:3998-4008.
  212. Reece TB, Maxey TS, Kron IL. A prospectus on tissue adhesives. The American Journal of Surgery. 2001;182(2, Supplement 1):40S-4S.
  213. Providing yearly figures allows the estimation of cumulative percent incidence, or incidence as a fraction of observation years. It is good practise for manufacturers to perform these calculations for themselves on a regular basis. For implants such as surgical meshes, Kaplan - Meier analysis is preferred. This sort of analysis is often performed with revision surgery (i.e. % requiring revision at 1, 2, 3, etc. years from the time of primary surgery as an end point), but it can also be performed on many other endpoints.
  214. Brown CN, Finch JG. Which mesh for hernia repair? Annals of The Royal College of Surgeons of England. 2010;92(4):272-8
  215. Dwyer P. Evolution of biological and synthetic grafts in reconstructive pelvic surgery. International Urogynecological Journal. 2006;17:S10-S5
  216. Bjelic-Radisic V, Aigmueller T, Preyer O et al. Vaginal prolapse surgery with transvaginal mesh: results of the Austrian registry. International Urogynecology Journal. 2014;25(8):1047-52
  217. Nilsson EK, Haapaniemi S. The Swedish hernia register: an eight year experience. Hernia. 2000;4:286-9
  218. Stechemesser B, Jacob DA, Schug-Pass C, Kockerling F. Herniamed: an internet-based registry for outcome research in hernia surgery. Hernia. 2012;16(3):269-76
  219. Americas Hernia Society Quality Collaborative (AHSQC) -
  220. European Registry of Abdominal Wall Hernias (EuraHS) -
  221. (France). ClubHernie aims to improve the quality of care in parietal surgery through various activities, such as the evaluation of professional practices (through a register), and by organising and publishing clinical research.
  222. Jia X, Glazener C, Mowatt G et al. Systematic review of the efficacy and safety of using mesh in surgery for uterine or vaginal vault prolapse. Int Urogynecol J. 2010;21(11):1413-31
  223. Aslani N, Brown CJ. Does mesh offer an advantage over tissue in the open repair of umbilical hernias? A systematic review and meta-analysis. Hernia. 2010;14:455-62
  224. Hobart WH. Clinical Outcomes of Biologic Mesh. Surgical Clinical of North America. 2013;93(5):1217-25
  225. Bellows CF, Smith A, Malsbury J, Helton WS. Repair of incisional hernias with biological prosthesis: a systematic review of current evidence. American Journal of Surgery. 2013;205(1):85-101.
  226. Bump RC, Mattiasson A, Bø K et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. American Journal of Obstetrics and Gynecology. 1996;175(1):10-7
  227. Lamb ADG, Robson AJ, Nixon SJ. Recurrence after totally extra-peritoneal laparoscopic repair: implications for operative technique and surgical training. Surgeon. 2006;4(5)
  228. Salamon CG, Culligan PJ. Subjective and objective outcomes one year after robotic-assisted laparoscopic sacrocolpopexy. Journal of Robotic Surgery. 2012;7(1):35-8
  229. Ferroli P, Acerbi F, Broggi M et al. A novel impermeable adhesive membrane to reinforce dural closure: a preliminary retrospective study on 119 consecutive high-risk patients. World Neurosurgery. 2013;79(3-4):551-7
  230. von der Brelie C, Soehle M, Clusmann HR. Intraoperative sealing of dura mater defects with a novel, synthetic, self adhesive patch: application experience in 25 patients. British Journal of Neurosurgery. 2012;26(2):231-5.
  231. Kaul A, Hutfless S, Le H et al. Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis. Surgical Endoscopy. 2012;26:1269-78.
  232. Topart P, Vandenbroucke F, Lozac'h P. Tisseel vs tack staples as mesh fixation in totally extraperitoneal laparoscopic repair of groin hernias. Surgical Endoscopy. 2005;19:724-7.
  233. Schwab R, Willms A, Kröger A, Becker HP. Less chronic pain following mesh fixation using a fibrin sealant in TEP inguinal hernia repair. Hernia. 2006;10(3):272-7.
  234. Sanjay P, Watt DG, Wigmore SJ. Systematic review and meta-analysis of haemostatic and biliostatic efficacy of fibrin sealants in elective liver surgery. Journal of Gastrointestinal Surgery. 2013;17(4):829-36
  235. Therapeutic Goods Administration. AusPAR: Fibrin adhesive/sealant. Australian Public Assessment Report 2014 [cited 29 Oct 2014];
  236. ASTM F2503-13, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, ASTM International, West Conshohocken, PA, 2013
  237. Shellock FG, Woods TO, Crues JV, 3rd. MR labeling information for implants and devices: explanation of terminology. Radiology. 2009;253(1):26-30
  238. Gold MR, Kanal E, Schwitter J, Sommer T, Yoon H, Ellingson M, et al. Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use. Heart Rhythm. 2014
  239. U.S. FDA. Establishing safety and compatibility of passive implants in the magnetic resonance (MR) environment: Guidance for industry and Food and Drug Administration staff. RockvilleMD2014 [updated 2014].
  240. American Society for Testing and Materials International. Designation: ASTM F2052-14, standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. West Conshohocken, Pa: American Society for Testing and Materials International, 2014.
  241. American Society for Testing and Materials International. Designation: ASTM F2213-06 (Reapproved 2011), standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. West Conshohocken, Pa: American Society for Testing and Materials International, 2011.
  242. American Society for Testing and Materials International. Designation: ASTM F2182-11a, standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging. West Conshohocken, Pa: American Society for Testing and Materials International, 2011.
  243. American Society for Testing and Materials International. Designation: ASTM F2119-07 (Reapproved 2013), standard test method for evaluation of MR image artifacts from passive implants. West Conshohocken, Pa: American Society for Testing and Materials International, 2013.
  244. Patel KH, Lambiase PD. The subcutaneous ICD-current evidence and challenges. Cardiovasc Diagn Ther. 2014;4(6):449-59
  245. Linde C, Ellenbogen K, McAlister FA. Cardiac resynchronization therapy (CRT): clinical trials, guidelines, and target populations. Heart Rhythm. 2012;9(8 Suppl):S3-s13
  246. Krahn AD, Klein GJ, Yee R, Skanes AC. The use of monitoring strategies in patients with unexplained syncope--role of the external and implantable loop recorder. Clin Auton Res. 2004;14 Suppl 1:55-61
  247. Ahmed FZ, Morris GM, Allen S, Khattar R, Mamas M, Zaidi A. Not all pacemakers are created equal: MRI conditional pacemaker and lead technology. J Cardiovasc Electrophysiol. 2013;24(9):1059-65
  248. Ainslie M, Miller C, Brown B, Schmitt M. Cardiac MRI of patients with implanted electrical cardiac devices. Heart. 2014;100(5):363-9
  249. Beinart R, Nazarian S. Effects of external electrical and magnetic fields on pacemakers and defibrillators: from engineering principles to clinical practice. Circulation. 2013;128(25):2799-809
  250. Chow GV, Nazarian S. MRI for patients with cardiac implantable electrical devices. Cardiol Clin. 2014;32(2):299-304
  251. Ferreira AM, Costa F, Tralhao A, Marques H, Cardim N, Adragao P. MRIi-conditional pacemakers: Current perspectives. Medical Devices: Evidence and Research. 2014;7(1):115-24
  252. Nazarian S, Beinart R, Halperin HR. Magnetic resonance imaging and implantable devices. Circ Arrhythm Electrophysiol. 2013;6(2):419-28
  253. Shinbane JS, Colletti PM, Shellock FG. Magnetic resonance imaging in patients with cardiac pacemakers: era of "MR Conditional" designs. J Cardiovasc Magn Reson. 2011;13:63
  254. van der Graaf AWM, Bhagirath P, Gotte MJW. MRI and cardiac implantable electronic devices; current status and required safety conditions. Neth Heart J. 2014;22(6):269-76
  255. Wilkoff BL, Bello D, Taborsky M, Vymazal J, Kanal E, Heuer H, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm. 2011;8(1):65-73
  256. Cohen JD, Costa HS, Russo RJ. Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. Am J Cardiol. 2012;110(11):1631-6
  257. Adapted from GHTF document, Principles of Conformity Assessment for Medical Devices, SG1/N78:2012
  258. US Food and Drug Administration. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff. Federal Register. 2014:39
  259. Watt A, Cameron A, Sturm L et al. Rapid reviews versus full systematic reviews: an inventory of current methods and practice in health technology assessment. Int J Technol Assess Health Care. 2008;24:133-9.
  260. Mann CJ. Observational research methods. Research design II: cohort, cross sectional, and case-control studies. Emergency medicine journal. 2003;20:54-60
  261. Yue LQ. Statistical and regulatory issues with the application of propensity score analysis to nonrandomized medical device clinical studies. J Biopharm Stat. 2007;17:1-13; discussion 5-7, 9-21, 3-7 passim
  262. Yue LQ. Regulatory considerations in the design of comparative observational studies using propensity scores. J Biopharm Stat. 2012;22:1272-9

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