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Best Practice Papers

A training paradigm to enhance performance and safe use of an innovative neuroendovascular device

, MD, , MD, , MD, , BASc & , MD, PhD
Article: 33248 | Received 12 Oct 2016, Accepted 24 Aug 2016, Published online: 09 Nov 2016

References

  • Administration CfDaRHUSFaD. Medical device home use initiative. 2010. Available from: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf..
  • World Health Organization. Medical devices: Managing the mismatch: An outcome of the priority medical devices project. 2010; World Health Organization. Available from: http://apps.who.int/iris/bitstream/10665/44407/1/9789241564045_eng.pdf.
  • Sulek K., Nobel prize for Andre F. Cournand Werner T. O. Forssmann and Dickinson W. Richards in 1956 for the discovery related to heart catheterization and studies on pathological changes in the cardiovascular system. Wiad Lek. 1969; 22(2): 203–4.
  • Simpson JB, Baim DS, Robert EW, Harrison DC. A new catheter system for coronary angioplasty. Am J Cardiol. 1982; 49: 1216–22.
  • Rankin JM, Spinelli JJ, Carere RG, Ricci DR, Penn IM, Hilton JD, etal. Improved clinical outcome after widespread use of coronary-artery stenting in Canada. N Engl J Med. 1999; 341(26): 1957–65.
  • Webb JG, Chandavimol M, Thompson CR, Ricci DR, Carere RG, Munt BI, etal. Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation. 2006; 113(6): 842–50.
  • De Jong WH, Borm PJ. Drug delivery and nanoparticles: Applications and hazards. Int J Nanomed. 2008; 3(2): 133–49.
  • Ensminger W, Niederhuber J, Dakhil S, Thrall J, Wheeler R. Totally implanted drug delivery system for hepatic arterial chemotherapy. Cancer Treat Rep. 1981; 65(5–6): 393–400.
  • Hopf-Jensen S, Preiß M, Marques L, Lehrke S, Schattschneider J, Stolze H, etal. Impact and effectiveness of dual aspiration technique in stent-assisted mechanical thrombectomy: Recent improvements in acute stroke management. Cardiovasc Intervent Radiol. 2016; 39(11): 1620–8.
  • McCabe JM, Huang PH, Riedl L, Eisenhauer AC, Sobieszczyk P. Usefulness and safety of ultrasound-assisted catheter-directed thrombolysis for submassive pulmonary emboli. Am J Cardiol. 2015; 115(6): 821–4.
  • Störger H, Ruef J. Closure of guide wire-induced coronary artery perforation with a two-component fibrin glue. Catheter Cardiovasc Interv. 2007; 70(2): 237–40.
  • Marotta TM, Riina HA, McDougall I, Ricci DR, Killer-Oberpfalzer M . Physiologic remodeling of bifurcation aneurysm: Pre-clinical results of the eCLIPs device. J Neurosurg. 2016, [in press]
  • Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006; 355(9): 928–39.
  • Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: A systematic review and meta-analysis. Lancet Neurol. 2011; 10(7): 626–36.
  • Rinkel GJ, Djibuti M, Algra A, van Gijn J. Prevalence and risk of rupture of intracranial aneurysms: A systematic review. Stroke. 1998; 29(1): 251–6.
  • Keedy A. An overview of intracranial aneurysms. McGill J Med. 2006; 9(2): 141–6.
  • Roy D, Milot G, Raymond J. Endovascular treatment of unruptured aneurysms. Stroke. 2001; 32: 1998–2004.
  • Chiu AH, De Vries J, O'Kelly C, Riina HA, McDougall I, Tippett J. The second generation eCLIPs endovascular clip system: Initial experience. J Neurosurg. 2016, [in press].
  • EEC. COUNCIL DIRECTIVE 93/42/EEC concerning medical devices. 1993; Emergo Group. Available from: http://www.emergogroup.com/sites/default/files/file/europe-consolidated-mdd-93-42-eec.pdf [cited 14 June 1993]..
  • European Standard EI. 2012. Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01).
  • FDA US. ‘Off-label’ and investigational use of marketed drugs, biologics, and medical devices – Information sheet. Guidance for Institutional Review Boards and Clinical Investigators. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm2016.
  • Bartolini B, Blanc R, Pistocchi S, Redjem H, Piotin M. ‘Y’ and ‘X’ stent-assisted coiling of complex and wide-neck intracranial bifurcation aneurysms. AJNR Am J Neuroradiol. 2014; 35(11): 2153–8.
  • World Health Organization. Medical devices: Managing the mismatch. Increasing complexity of medical technology and consequences for training and outcome of care. 2010; Geneva: World Health Organization.