Disclosures US Patent and Applications Pending: U.S. Pat. App. - PowerPoint PPT Presentation

4/14/2016 Disclosures • US Patent and Applications Pending: U.S. Pat. App. No. 13706036 - Debranching Stent Graft Limb and - My Techniques to Manage the Methods for Use U.S. Pat. App. No. 13706086 - Visceral Double-Barreled Main Body - Stent Graft and Methods for Use Challenging (Non-IFU) Aortic Neck U.S. Pat. App. No. 13706127 - Debranching Visceral Stent Graft - and Methods for Use U.S. Pat. App. No. 13706144 - Aortic Arch Double-Barreled Main - Body Stent Graft and Methods for Use U.S. Pat. App. No. 13706158 - Debranching Great Vessel Stent - Graft and Methods for Use U.S. Pat. App. No. 13706175 - Combination Double-Barreled and - Debranching Stent Grafts and Methods for Use U.S. Pat. App. No. 61740161 - Stent Deployment Device - • License Agreement With MDT Patrick W. Kelly, MD, FACS Disclaimer The Non-IFU Neck This Presentation discusses the use of an investigational device under PSIDE G140207. Angulated * Straight Tapered Reversed tapered Bulge Short + Source: Ionel Droc, Dieter Raithel and Blanca Calinescu (2012). Abdominal Aortic Aneurysms - Actual Therapeutic Strategies, Aneurysm, Dr. Yasuo Murai (Ed.), ISBN: 978-953-51-0730-9, InTech, DOI: 10.5772/48596 * Modified from source + additional anatomical criteria, not part of source 1

4/14/2016 What Are The Failure Mode of the Non IFU Aortic Neck IFU Deviations • > 60 degrees • > 60 degrees – Type 1 EndoLeak • > 32mm – Migration • < 10mm though this varies with manufacture • +/- Thrombus/ Calcifications What Are The Failure Mode of the What Are The Failure Mode of the IFU Deviations IFU Deviations • Dilated Neck >32mm • Short Neck <10mm – Type I EndoLeak – Type I EndoLeak – Migration – Migration • Catastrophic collapse into the Aneurysm Sake • Catastrophic collapse into the Aneurysm Sake – Advancement of the Aneurysm Proximally – Advancement of the Aneurysm Proximally 2

4/14/2016 What Are The Failure Mode of the In Isolation IFU Deviations • Thrombus/ Calcification • One Deviation From IFU – Type 1 EndoLeak – Doable • With the caveat >34mm dia and Neck <5mm – Migration • Will Need to Consider Adjuncts – Embolization • Two Or More Deviations From IFU – Aortic Leak With Proximal Ballooning – Look to More Aortic coverage/ Fixation • Endo Anchors • Parallel Grafting • Investigational Device Successful EVAR My Approach • Fixation • Seal • Flow 3

4/14/2016 First Step In My Algorithm Surgical Repair • Look at the PATIENT • Primary Abdominal Aortic Repair – Performance status • Hybrid Repair • Solid – Before EVAR • Compromise • Renal Bypass to Gain Affective Neck Length • Extreme Risk – After Failed EVAR Open Surgery It Still Works • Renal Bypass to Gain Affective Neck Length • Napkin Ring (Create A New Neck) Napkin Ring Endo Treatments • Increase Affective Neck Length – Anchors – Parallel (Longitudinal Grafts) – Investigational Device 4

4/14/2016 Endo Anchors Parallel Graft 3 mm Cross Bar 1.0 mm 3.5 mm IDE Our IDE device Device 5

4/14/2016 Unitary Stent Graft System Unitary Fixation 40-50 mm Long Main Body 6-8mm Visceral Limbs 6-8 mm Visceral Limbs 13-14mm InfraRenal Extension 13-14 mm InfraRenal Extension Type IV TAAA Proximal Deployment Proximal Deployment Place the Unitary Graft above the “branch vessels.” Of Unitary Graft This allows for continued perfusion throughout the procedure. 6

4/14/2016 Type IV TAAA Endo-Bypass Endo-Bypass Each of the branch vessels are stented individually from a position more proximally. These bridging stents are slightly longer, but the favorable flow characteristics and conformability to anatomic variations mirror many of the lessons we’ve learned from open bypass. Type IV TAAA Type IV TAAA Endo-Bypass Endo-Bypass 7

4/14/2016 Type IV TAAA Delayed Distal Seal Endo-Bypass Once flow has been secured to each of the involved branches, then the open limb of the unitary graft can be extended distally excluding the diseased segment of vessel . Type IV TAAA Type IV TAAA Delayed Distal Seal Delayed Distal Seal 8

4/14/2016 Type IV TAAA Thank You 9