12. Miller DC, et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012; 143(4):832-843.e13. 13. Reynolds MR, et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011; 124(18):1964-72. 14. Smith CR, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23):2187-98. 15. Leon MB, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363(17):1597-607. APPENDIX 3 ANZ TAVI Platforms Summary First in CE Mark FDA TGA Product Name Company Man Valve Design Approval Approval Approval Completed Balloon Expanded SAPIEN TF EL April 2002 Sept 2007 Nov 2011 Sept 2013 Stainless Steel – Frame Self- Expanding CoreValve - TF Med July 2004 May 2007 Jan 2014 - Nitinol Balloon Expanded SAPIEN TA EL Nov 2005 Sept 2007 Oct 2012 Sept 2013 Stainless Steel – Frame Balloon Expanded March SAPIEN XT TF EL 2008 June 2014 - Cobalt Chromium – 2010 Frame Balloon Expanded SAPIEN XT TA March – EL 2008 June 2014 - Cobalt Chromium / Tao 2010 Frame Balloon Expanded SAPIEN 3 TF EL 2009 Jan 2014 - - Cobalt Chromium – Frame Balloon Expanded SAPIEN 3 TA / – EL 2009 Jan 2014 - - Cobalt Chromium Tao Frame Self- Expanding Lotus BS 2010 Oct 2013 - - Nitinol Self- Expanding PORTICO TF StJ June 2011 Nov 2012 - - – Nitinol Self- Expanding PORTICO TA StJ Nov 2012 - - - – Nitinol Corevalve Evolut Self- Expanding Med Sept 2013 - - - R Nitinol
12. Miller DC, et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012; 143(4):832-843.e13. 13. Reynolds MR, et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011; 124(18):1964-72. 14. Smith CR, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23):2187-98. 15. Leon MB, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363(17):1597-607. APPENDIX 3 ANZ TAVI Platforms Summary Product Name Company First in Man Completed CE Mark Approval FDA Approval TGA Approval Valve Design SAPIEN – TF EL April 2002 Sept 2007 Nov 2011 Sept 2013 Balloon Expanded Stainless Steel Frame CoreValve - TF Med July 2004 May 2007 Jan 2014 - Self- Expanding Nitinol SAPIEN – TA EL Nov 2005 Sept 2007 Oct 2012 Sept 2013 Balloon Expanded Stainless Steel Frame SAPIEN XT – TF EL 2008 March 2010 June 2014 - Balloon Expanded Cobalt Chromium Frame SAPIEN XT – TA / Tao EL 2008 March 2010 June 2014 - Balloon Expanded Cobalt Chromium Frame SAPIEN 3 – TF EL 2009 Jan 2014 - - Balloon Expanded Cobalt Chromium Frame SAPIEN 3 – TA / Tao EL 2009 Jan 2014 - - Balloon Expanded Cobalt Chromium Frame Lotus BS 2010 Oct 2013 - - Self- Expanding Nitinol PORTICO – TF StJ June 2011 Nov 2012 - - Self- Expanding Nitinol PORTICO – TA StJ Nov 2012 - - - Self- Expanding Nitinol Corevalve Evolut R Med Sept 2013 - - - Self- Expanding Nitinol
1361-TAVI-FinalProtocol-accessible.docx