Nellix Endovascular System: Clinical Outcomes and Device Overview
|
|
- Lillian Morrison
- 5 years ago
- Views:
Transcription
1 Nellix Endovascular System: Clinical Outcomes and Device Overview Jeffrey P. Carpenter, MD Professor and Chief, Department of Surgery CAUTION: Investigational device. This product is under clinical investigation outside of the United States. It has not been approved for clinical investigation or for marketing in the United States. MM0201 Rev. 01
2 Current State of EVAR Benefits vs. OSR in Multiple Trials Various Stent Graft Devices Available Proximal Infrarenal Fixation Proximal Suprarenal Fixation Anatomical Fixation Limitations Anatomies (e.g., Necks: <10mm, irregular, angulated) Complications Distal and lateral migration Endoleaks Occlusions Secondary Procedures
3 Case Control Studies RCTs EVAR Secondary Procedures Trial/Author Year N Follow-Up Years (Mean or Median) Secondary Procedures (% of Pts) EVAR EVAR DREAM OVER Carpenter Conrad Mehta , AbuRahma Dias Abbruzzese Pitoulias Kim Schermerhorn , Total 3.5 Years 18%
4 J Vasc Surg 2010;52: Number of Patients 1,768 Mean Follow-up [SD] 34 Months [30] % with Secondary Intervention 19.2% Type II Endoleak 40% Type I/III Endoleak 17% 7.7% of Pts Migration 14% Limb Occlusion 7.4% Other 22%
5 Pts Free from Sac Enlargement or Intervention Type II Endoleak Collateral Vessel Communication with Sac Lumbar, IMA, hypogastric, sacral, gonadal, or accessory renal artery 10-25% Incidence Post-EVAR 1,2,3 5-25% require intervention Predictors: o Patent IMA o Neck length o #Collaterals o Sac thrombus P< Rhee SJ, et al. AVS 2003;17; vanmarrewijk CJ, et al. EJVES 2004;27: Timaran C, et al. JVS 2004;39;
6 5-Year Costs Following EVAR ($US) Event No Yes Endoleak $5,706 $26,739 Secondary Intervention $3,668 $31,696 Efforts aimed at minimizing cost should emphasize technical and device modifications aimed at reducing endoleaks and the need for secondary procedures. Noll RE, et al. J Vasc Surg 2007;46:9-15.
7 Nellix Endovascular System Novel AAA Sac Sealing Technology Bilateral stents deployed to create blood flow lumens to distal anatomy Endobags filled with biostable polymer create seal Simple, predictable procedure Design Goals Treat wide range of AAA anatomies Reduce secondary procedures and follow-up surveillance Effectively prevent aneurysm rupture
8 Ovine Anterior Patch Model Preclinical Type II Endoleak Obliteration 31mm diameter aneurysm sac created Lumbar artery preservation
9 Nellix Device Design Stent Endobag Biostable Polymer Filled Endobags Around Stents
10 Sizing Matrix 14 Devices Device Lengths (mm) Aortic Neck Diameter (mm) Aortic Blood Lumen Diameter (mm) Common Iliac Artery Diameter (mm) 60, 80, 100, 120, 140, 160, , 80, 100, 120, 140, 160,
11 The Nellix Procedure Introduce catheters over.035 guidewires Balloon expand stents Fill Endobags with Polymer
12 Device Design and Displacement Forces 1 Baseline (Untreated) Proximal Bifurcation Mid Bifurcation Distal Bifurcation Total Displacement Force (N) Anterior Lateral Axial PA Segalova et al. Presented at the 2011 ASME Bioengineering Conference.
13 Hemodynamics after EVAR Modeling of the Effects of Nellix and Proximal Fixation EVAR Devices on Blood Flow Using Computational Methods 1 Pulsatile Flow Wall Shear Stress Patient Specific Geometry Pressure Drop Proximal Fixation Nellix Treated 1 Charles Taylor, PhD and Nathan Wilson, PhD - Cardiovascular Simulation Inc. 2008
14 Mean Wall Shear Stress 4.8 dynes/cm dynes/cm 2 Nellix Device Proximal Fixation Endograft 0 Mean Wall Shear Stress (dynes/cm 2 ) 10
15 Mean Pressure Drop Across Grafts Nellix Graft Infrarenal: mmhg Iliacs: mmhg Difference: 0.41 mmhg Proximal Fixation Endograft Infrarenal: mmhg Iliacs: mmhg Difference: 0.43 mmhg Infrarenal: mmhg Iliacs: mmhg Infrarenal: mmhg Iliacs: mmhg Difference: 0.57 mmhg Difference: 0.67 mmhg
16 Four International Centers Experienced in EVAR 1st Generation Nellix Device 34 Patients Enrolled 8/2008 to 1/2010 Independent CEC and DSMB Primary Endpoints at 30 Days: Safety: Complications vs. SVS surgical control Efficacy: Technical success + free from open repair Additional Endpoints: CE Trial Overview Clinical utility outcomes Long-term adverse events Independent Core Lab (M2S, Inc.) review of CT scans
17 Demographics and Risk Factors Demographic Result* (N=34) Male Gender 91% Age, years 71 ± 7.6 Total AAA Vol., ml 178 (68 363) AAA Sac Dia., cm 5.8 ( ) Blood Lumen Dia., cm 4.2 ( ) Neck Dia., mm 24 (18 31) Neck Length, mm 21 (5.0 50) Neck Angulation, 37 (9.1 72) Risk Factor Result* (N=34) CAD 56% CHF 17% COPD 39% Hypertension 68% PAOD 21% Prior CABG/PCI 56% Prior MI 26% Smoking 50% *Result shown as %, mean ± SD, or mean (range)
18 Preoperative Neck Anatomy (N=34) Short Neck (<10mm) Angulated Neck (>60 ) Large CIAA (>23mm) Any of the 3
19 Type II Endoleak Risk Factors (N=34) Multiple Lumbar Arteries (5+) Low Sac Thrombus Load (<25%) Patent IMA Any of the 3
20 Procedural / In-Hospital Outcomes Parameter Result * Device Implant Time (min) 70 (33-150) Fluoroscopy Time (min) 33 (13-71) Total Procedure Time (min) 127 (80-148) Estimated Blood Loss (ml) 165 (35-400) Polymer Fill Volume (ml) 73 (18-168) Time to Hospital Discharge (days) 3.8 (1-9) *Results shown as mean (range) 100% Procedural Technical Success One death on POD 3 (Multiorgan System Failure) determined by DSMB to not be device related
21 Primary Safety Results at 30 Days CEC Adjudicated Results Event Nellix (N=34) SVS Control (N=243) P-value Any Complication 1 (2.9%) 136 (56%) <.0001 Mortality 1 (2.9%) 7 (2.9%) --- Bowel Ischemia Myocardial Infarction 0 13 (5.3%) --- Paraplegia Blood Loss 1000mL (51%) --- Renal Failure 1 (2.9%) 7 (2.9%) --- Respiratory Failure 0 14 (5.8%) --- Stroke 0 3 (1.2%) --- *Results shown as number of patients with event (% of total)
22 Major Adverse Events to 2 Years CEC Adjudicated Results Event 0 30 Days (N=34) 31 Days to 1 Yr (N=33) >1 Yr (N=32) Pts with 1 MAE 1 (2.9%) 2 (6.1%) 1 (3.1%) Mortality 1 (2.9%) 1 (3.0%) 1 (3.1%) AAA-Related Mortality 1 (2.9%) 0 0 Bowel Ischemia Myocardial Infarction 0 1 (3.0%) 0 Renal Failure 1 (2.9%) 0 0 Respiratory Failure Secondary Procedure 1 (2.9%) 0 1 (3.1%) *Results shown as number of patients with event (% of total)
23 Secondary Interventions 34 Patients with up to 2 Year Follow-up 2/34 (5.9%) with Intervention Exploratory laparotomy for renal insufficiency on day 3 (no conversion) Embolization and stent insertion for distal Type I endoleak at 15 months Inadequate Device Length* *Commercially available AneuRx extension used intraop; Nellix extenders not available at this time.
24 Diameter (mm) Aneurysm Sac Stability 65 N=34 N=33 N=33 N=32 N= Pre-Op 1 Month 6 Months 1 Year 2 Years ± ± ± ± ± 9.0
25 Core Lab Evaluations to 2 Years 0% Aneurysm Rupture 0% Migration 0% Conversion to Open Repair 0% Stent Fracture 0% Endobag Failure 0% Type II, III, or IV Endoleak 0% Sac Expansion 0% Limb Occlusion
26 Nellix Pre and Post Implant Anterior Slide 27
27 Case Overview 6.0cm AAA with 10mm Length Neck and 3.5cm RCIAA Pre-Operative Post-Operative R hypogastric artery preserved with Nellix extender 1-Year
28 Elimination of Potential Type II Endoleak Pre-treatment large IMA Post-Nellix IMA trunk occluded Note marginal and superior rectal branches (arrows) ( neck ) Aorta 22 Max Sac Lumen 24 L iliac R iliac 13
29 Case Overview Large 7.6cm AAA with Low Thrombus Load Pre-Op 1 Yr Post-Op
30 Case Overview 5.4cm AAA with 5mm Length Neck and Bilateral CIAA >2.5cm Pre-Op 1 Month 1 Year No change in implant stability or sac diameter over time
31 Summary The initial safety and effectiveness of the Nellix sac sealing technology is very encouraging No Type II endoleak despite presence of risk factors Absence of rupture, conversion, stent occlusion, migration Low rate of secondary interventions Simplified surveillance (e.g., ultrasound) may be justified leading to reduced costs post EVAR Longer follow-up and increased experience needed
32 Current and Future EVAR Devices Profile Neck Neck Iliac Company Device (OD) Length Diameter Diameter Endologix AFX 19F 15mm 32mm 23mm Medtronic Endurant 18F - 20F 10mm 32mm 25mm Cook Zenith LP 16F - 18F 15mm 32mm 20mm Gore C3 18F - 20F 15mm 29mm 18.5mm Trivascular Ovation 14F - 15F 7mm 30mm 20mm Endologix Nellix* 17F 5mm 36mm 35mm JNJ Incraft 14F 15mm 31mm 22mm Terumo Anaconda 21F - 23F 15mm 31mm 21mm *Expected profile and indications for commercial device Nellix is expected to treat more AAA anatomies than other EVAR devices and is the only device that completely seals the aneurysm sac
33 Forward Looking Final device design enhancements and testing in process CE Mark anticipated with initial European introduction in 2012 US IDE anticipated to initiate 2012
Mid-term results of 300+ patients treated by endovascular aortic sealing (EVAS)
Mid-term results of 300+ patients treated by endovascular aortic sealing (EVAS) Jean-Paul P.M. de Vries Dept Vascular Surgery St. Antonius Hospital, Nieuwegein,The Netherlands On behalf of the DEVASS study
More informationThe Ventana Off-the-Shelf Graft for Pararenal AAA. Andrew Holden Associate Professor of Radiology Auckland Hospital
The Ventana Off-the-Shelf Graft for Pararenal AAA Andrew Holden Associate Professor of Radiology Auckland Hospital Disclosures Andrew Holden, MBChB, FRANZCR Investigator in Nellix and Ventana Trials Clinical
More informationHistory of the Powerlink System Design and Clinical Results. Edward B. Diethrich Arizona Heart Hospital Phoenix, AZ
History of the Powerlink System Design and Clinical Results Edward B. Diethrich Arizona Heart Hospital Phoenix, AZ Powerlink System: Unibody-Bifurcated Design Long Main Body Low-Porosity Proprietary eptfe
More informationImproving Endograft Durability with EndoAnchors
Improving Endograft Durability with EndoAnchors William D. Jordan, Jr., M.D. John E. Skandalakis Chair in Surgery Professor and Chief Division of Vascular Surgery and Endovascular Therapy Emory University
More informationEndoVascular Aneurysm Sealing (EVAS) with Nellix
1 2 EndoVascular Aneurysm Sealing (EVAS) with Nellix Designed to seal entire aneurysm with contained biostable polymer Non-modular design with complete fixation Expands endovascular patient eligibility
More informationYoung-Guk Ko, M.D. Severance Cardiovascular Hospital, Yonsei University Health System,
Young-Guk Ko, M.D., Dangas G, J Am Coll Cardiol Intv 2012;5:1071 All-cause Mortality Dangas Severance G, J Am Coll Cardiovascular Cardiol Intv Hospital, 2012;5:1071 Yonsei University Health System Aneurysm-related
More informationOvation. Sean Lyden, MD Department Chair, Vascular Surgery Cleveland Clinic
Ovation Sean Lyden, MD Department Chair, Vascular Surgery Cleveland Clinic Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement
More informationINCRAFT system: Update from the Pivotal INSPIRATION Study
INCRAFT system: Update from the Pivotal INSPIRATION Study Michel S. Makaroun MD Co-Director, UPMC Heart and Vascular Institute Professor and Chair, Division of Vascular Surgery University of Pittsburgh
More informationHostile Proximal Neck: A New Conformable EVAR Device
Hostile Proximal Neck: A New Conformable EVAR Device Young-Guk Ko, M.D., Seoul, Korea Currently Available Devices for EVAR in Korea, 2018 Zenith Flex, Cook Endurant IIs, Medtronic INCRAFT, Cordis AFX2,
More informationCurrent Status of EVAR for Infrarenal AAA. 31 st Annual Florida Vascular Society. PENN Surgery
Current Status of EVAR for Infrarenal AAA 31 st Annual Florida Vascular Society PENN Surgery No Disclosures Stent Grafts Design Related Differences What really matters? Modular Unibody Supported Unsupported
More informationDurability of The Endurant Stent-Graft through 5 Years
Durability of The Endurant Stent-Graft through 5 Years Michel S. Makaroun MD Co-Director, UPMC Heart and Vascular Institute Professor and Chair, Division of Vascular Surgery University of Pittsburgh School
More informationDegeneration of the Neck Post Implementation - a New Era of AAA Stent
Degeneration of the Neck Post Implementation - a New Era of AAA Stent New Mexico Heart Institute Albuquerque, New Mexico USA - Gore Current FDA-Approved EVAR Devices Sealing Mechanism Endologix Lombard
More informationEndovascular Repair o Abdominal. Aortic Aneurysms. Cesar E. Mendoza, M.D. Jackson Memorial Hospital Miami, Florida
Endovascular Repair o Abdominal Aortic Aneurysms Cesar E. Mendoza, M.D. Jackson Memorial Hospital Miami, Florida Disclosure Nothing to disclose. 2 Mr. X AAA Mr. X. Is a 70 year old male who presented to
More informationImportant Update to Field Safety Notice Nellix EndoVascular Aneurysm Sealing System Updated Instructions for Use (IFU)
October 6, 2017 Important Update to Field Safety Notice Nellix EndoVascular Aneurysm Sealing System Updated Instructions for Use (IFU) Dear Physician, This notification is to provide you with further information
More informationOptimizing Accuracy of Aortic Stent Grafts in Short Necks
Optimizing Accuracy of Aortic Stent Grafts in Short Necks Venkatesh Ramaiah, MD, FACS Medical Director Arizona Heart Hospital Director Peripheral Vascular and Endovascular Research Arizona Heart Institute
More informationAbdominal and thoracic aneurysm repair
Abdominal and thoracic aneurysm repair William A. Gray MD Director, Endovascular Intervention Cardiovascular Research Foundation Columbia University Medical Center Abdominal Aortic Aneurysm Endografts
More informationAbdominal Aortic Aneurysm (AAA)
Abdominal Aortic Aneurysm (AAA) Vascular Workshop: Objectives Anatomy Keith VanHaltren Indications Technique Cases Abdominal Aorta: Normal Size Abdominal aortic aneurysm: Definition Normal diameter of
More informationCAUTION: The Nellix EndoVascular Aneurysm Sealing System is an investigational device. Limited by federal (or United States) law to investigational
Safety and Effectiveness Results of the Nellix System IDE Pivotal Trial for Endovascular Aneurysm Sealing PRESENTED BY: Jeffrey P. Carpenter, MD National Principal Investigator Professor and Chairman,
More informationDisclosures. EVAR follow-up: actual recommendation. EVAR follow-up: critical issues
Disclosures is it time to discuss individualized follow-up schemes based on preoperative anatomy and high quality completion angiography? Consultant / Speaker / Proctor Cook Cordis Medtronic Invatec W.L.
More informationA New EVAR Device for Infrarenal AAAs
A New EVAR Device for Infrarenal AAAs Peter Nelson, MD, MS Assistant Professor of Surgery MM0203 Rev. 01 Current U.S. EVAR Devices Anatomical Fixation Proximal Fixation Powerlink - Endologix Excluder WL
More informationAnalysis of Type IIIb Endoleaks Encountered with Endologix Endografts
Analysis of Type IIIb Endoleaks Encountered with Endologix Endografts Alan R. Wladis, MD, FACS, David Varnagy, MD, FACS, Manuel R. Perez-Izquierdo, MD, Mark Ranson, MD FACS, Delos Clift, MD FACS, Rebecca
More informationAortic Neck Issues Associated Clinical Sequelae/Implications for Graft Choice
Aortic Neck Issues Associated Clinical Sequelae/Implications for Graft Choice Eric Verhoeven, MD, PhD, A. Katsargyris, MD Department of Vascular and Endovascular Surgery, Paracelsus Medical University,
More informationTriVascular Ovation Prime Abdominal Stent Graft System
TriVascular Ovation Prime Abdominal Stent Graft System Science of the Seal O-Ring Sealing Technology O-Ring Sealing in Proven Engineering Solutions O-rings are designed to seal by blocking the flow of
More informationThe Auckland Experience with the Nellix EVAS System. Andrew Holden, MBChB, FRANZCR
The Auckland Experience with the Nellix EVAS System Andrew Holden, MBChB, FRANZCR Disclosure Speaker name: Associate Professor Andrew Holden I have the following potential conflicts of interest to report:
More informationEVAR replaced standard repair in most cases. Why?
EVAR replaced standard repair in most cases. Why? Initial major steps in endograft evolution Papazoglou O. Konstantinos M.D. The story of a major breakthrough in vascular surgery 1991 Parodi introduces
More informationConflicts of Interest. When and Why Complex EVAR in Tx of juxta/suprarenal AAA? Summary. Infrarenal EVAR for short necks 2y postop
When and Why Complex EVAR in Tx of juxta/suprarenal AAA? Tim Resch MD Vascular Center Skane University Hospital Conflicts of Interest COOK Medical - Consulting, Speakers Bureau, IP, Research support Medtronic
More informationENCORE, a Study to Investigate the Durability of Polymer EVAR with Ovation A Contemporary Review of 1296 Patients
ENCORE, a Study to Investigate the Durability of Polymer EVAR with Ovation A Contemporary Review of 1296 Patients The Ovation System is approved to treat infrarenal abdominal aortic aneurysms and is not
More informationNo Neck Is Needed! Treat the Aneurysm Instead! Andrew Holden, MD Associate Professor of Radiology Auckland City Hospital
No Neck Is Needed! Treat the Aneurysm Instead! Andrew Holden, MD Associate Professor of Radiology Auckland City Hospital Disclosures Andrew Holden, MBChB, FRANZCR No financial investment to disclose Investigator
More information14F OD Ovation Abdominal Stent Graft System
14F OD Ovation Abdominal Stent Graft System 2 Year Results from the European Study Dierk Scheinert, MD Center for Vascular Medicine Angiology and Vascular Surgery Park Hospital Leipzig, Germany Disclosure
More informationMy personal experience with INCRAFT in standard and challenging cases
My personal experience with INCRAFT in standard and challenging cases G Pratesi, MD Vascular Surgery University of Rome Tor Vergata giovanni.pratesi@uniroma2.it Disclosure Speaker name: Giovanni Pratesi,
More informationInfluence of patient selection and IFU compliance on outcomes following EVAS
Influence of patient selection and IFU compliance on outcomes following EVAS LUNCH SYMPOSIUM LINC 2017 Jan MM Heyligers, MD, PhD, FEBVS Consultant Vascular Surgeon Elisabeth TweeSteden Hospital Tilburg,
More informationBilateral use of the Gore IBE device for bilateral CIA aneurysms and a first interim analysis of the prospective Iceberg registry
Bilateral use of the Gore IBE device for bilateral CIA aneurysms and a first interim analysis of the prospective Iceberg registry Michel MPJ Reijnen, MD, PhD Department of Vascular Surgery, Rijnstate Hospital
More informationTreatment options of late failures of EVAS. Michel Reijnen Rijnstate Arnhem The Netherlands
Treatment options of late failures of EVAS Michel Reijnen Rijnstate Arnhem The Netherlands Disclosure Speaker name: Michel Reijnen I have the following potential conflicts of interest to report: Consulting
More informationAnatomy-Driven Endograft Selection for Abdominal Aortic Aneurysm Repair S. Jay Mathews, MD, MS, FACC
Anatomy-Driven Endograft Selection for Abdominal Aortic Aneurysm Repair S. Jay Mathews, MD, MS, FACC Interventional Cardiologist/Endovascular Specialist Bradenton Cardiology Center Bradenton, FL, USA Disclosures
More informationUse of Aptus Heli-FX EndoAnchor implants with standard endografts to strengthen seal in hostile anatomies:
Use of Aptus Heli-FX EndoAnchor implants with standard endografts to strengthen seal in hostile anatomies: technical tips, case experience and clinical results CACVS Medtronic Symposium Paris, France January
More informationLOWERING THE PROFILE RAISING THE BAR
LOWERING THE PROFILE RAISING THE BAR INNOVATIVE LOW PROFILE. ADVANCED CLINICAL PERFORMANCE. The AFX TM Endovascular AAA System integrates anatomical fixation with an advanced delivery system and graft
More informationAccess More Patients. Customize Each Seal.
Access More. Customize Each Seal. The Least Invasive Path Towards Proven Patency ULTRA LOW PROFILE TO EASE ADVANCEMENT The flexible, ultra-low 12F ID Ovation ix delivery system enables you to navigate
More informationTalent Abdominal Stent Graft
Talent Abdominal with THE Xcelerant Hydro Delivery System Expanding the Indications for EVAR Treat More Patients Short Necks The Talent Abdominal is the only FDA-approved device for proximal aortic neck
More informationNASDAQ: ELGX December Innovation that Empowers
NASDAQ: ELGX www.endologix.com December 2014 Innovation that Empowers Safe Harbor This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act
More informationChungbuk Regional Cardiovascular Center, Division of Cardiology, Departments of Internal Medicine, Chungbuk National University Hospital Sangmin Kim
Endovascular Procedures for Isolated Common Iliac and Internal Iliac Aneurysm Chungbuk Regional Cardiovascular Center, Division of Cardiology, Departments of Internal Medicine, Chungbuk National University
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE GUIDANCE EXECUTIVE (GE)
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE GUIDANCE EXECUTIVE (GE) Review of TA167; Endovascular stent-grafts for abdominal aortic aneurysms Final recommendation post consultation The guidance should
More informationCurrent Status of Abdominal Aortic Stent Grafts. John R. Laird Professor of Medicine Director of the Vascular Center UC Davis Medical Center
Current Status of Abdominal Aortic Stent Grafts John R. Laird Professor of Medicine Director of the Vascular Center UC Davis Medical Center Autumn Greetings Disclosure Statement of Financial Interest Within
More informationEVAS using Nellix in my practice Where are we today?
EVAS using Nellix in my practice Where are we today? Prof. dr. Michel MPJ Reijnen Department of Vascular Surgery, Rijnstate Hospital Arnhem Faculty of Science and Technology, University of Twente The Netherlands
More informationMid-term results from ANCHOR: How does this data influence the treatment algorithm for hostile EVAR anatomies
Mid-term results from ANCHOR: How does this data influence the treatment algorithm for hostile EVAR anatomies Jean-Paul P.M. de Vries Head Department of Surgery, University Medical Centre Groningen The
More informationEndovascular options of treating iliac aneurysms
Endovascular options of treating iliac aneurysms Marek Majewski Department of Vascular Surgery of P. Desgranges Henri Mondor Hospital University Paris XII Créteil, France Common Iliac Artery Aneurysms
More informationHow to select FEVAR versus EVAR + endoanchors in short-necked AAAs
How to select FEVAR versus EVAR + endoanchors in short-necked AAAs Jean-Paul P.M. de Vries, Richte C.L. Schuurmann St. Antonius Hospital Nieuwegein, The Netherlands 21st Critical Issues Congress Nuernberg,
More informationEVAS How does this Impact EVAR Therapy
EVAS How does this Impact EVAR Therapy John S. Lane III, MD, FACS Professor and Acting Chief of Vascular Surgery University of California, San Diego PNEC, 2017 Endologix products and associated components
More informationReduction in cardiovascular related adverse events following active sac management with Nellix vs. EVAR: Are there biological advantages?
February 1, 2018 Reduction in cardiovascular related adverse events following active sac management with Nellix vs. EVAR: Are there biological advantages? Patrick Berg M.D. Marienhospital Kevelaer Germany
More informationManagement of Endoleaks
Management of Endoleaks Murray Shames, MD Professor and Chief, Director Tampa General Hospital Aortic Program Vice Chair of Research, Dept. of Surgery Conflict of Interests: Speaker: Gore, Medtronic, Cook
More informationClinical trial and real-world outcomes of an endovascular iliac aneurysm repair with the GORE Iliac Branch Endoprosthesis (IBE)
Clinical trial and real-world outcomes of an endovascular iliac aneurysm repair with the GORE Iliac Branch Endoprosthesis (IBE) Jan MM Heyligers, PhD, FEBVS Consultant Vascular Surgeon The Netherlands
More information2015 Clinical Update Endovascular Systems for AAA Repair
Endovascular Systems for AAA Repair 2 Musick Irvine, CA 92618 Tel 949.595.7200 Fax 949.612.1893 www.endologix.com TABLE OF CONTENTS Section Page ABSTRACT... 3 READER S GUIDE... 4 SECTION 1: US PIVOTAL
More informationWhy Nellix? Treating Concomitant Common Iliac Aneurysms
INDICATIONS FOR USE The Nellix EndoVascular Aneurysm Sealing System can be used in patients who have an infrarenal abdominal aortic (AAA) or aortoiliac aneurysm with suitable anatomy as indicated below:
More informationsymptomatic aneurysms or aneurysms that grow >1cm/yr
1. Elective repair for aneurysm >5.5 cm, symptomatic aneurysms or aneurysms that grow >1cm/yr 2. Ruptured AAA Aneurysm Detection and Management Study (ADAM) and UK Small Aneurysm Trial early open surgery
More informationFaculty Disclosure. Glue, Particulates, Thrombin, Coils and the Kitchen Sink for Type II Endoleak Management. Background.
Glue, Particulates, Thrombin, Coils and the Kitchen Sink for Type II Endoleak Management Faculty Disclosure I disclose the following financial relationships: UCSF Vascular Symposium 2013 Receive grant/research
More informationPredictors of abdominal aortic aneurysm sac enlargement after EVAR Longterm results from the ENGAGE Registry
Predictors of abdominal aortic aneurysm sac enlargement after EVAR Longterm results from the ENGAGE Registry D. Böckler Department of Vascular and Endovascular Surgery University Hospital Heidelberg Disclosure
More informationEVAR Revision Setting - How can Heli-FX EndoAnchors improve the outcomes?
D. Böckler Department of Vascular and Endovascular Surgery University Hospital Heidelberg EVAR Revision Setting - How can Heli-FX EndoAnchors improve the outcomes? Disclosures Speaker name: Dittmar Böckler
More informationTechnique and Tips for Complicated AAA Cases with Stent Graft
Technique and Tips for Complicated AAA Cases with Stent Graft Seung-Woon Rha, MD, PhD FACC, FAHA, FESC, FSCAI, FAPSIC Cardiovascular Center, Korea University Guro Hospital Mar 15, 2018 LINC AP 2018 Endoleak;
More informationHostile Neck During EVAR, The Role Of Endoanchores
Hostile Neck During EVAR, The Role Of Endoanchores Samer Koussayer, MD, FACS, RVT Prof, Al Faisal University Section Head and consultant Vascular & Endovascular Surgery Division King Faisal Specialist
More informationEVAS is Associated with Lower All-Cause Mortality
EVAS is Associated with Lower All-Cause Mortality Marc L Schermerhorn, MD Chief, Division of Vascular and Endovascular Surgery Beth Israel Deaconess Medical Center Professor of Surgery Harvard Medical
More informationChallenges with Complex Anatomies Advancing Care in Endovascular Aortic Treatment
Challenges with Complex Anatomies Advancing Care in Endovascular Aortic Treatment Robert Y. Rhee, MD Chief, Vascular and Endovascular Surgery Director, Aortic Center Maimonides Medical Center Brooklyn,
More informationMODERN METHODS FOR TREATING ABDOMINAL ANEURYSMS AND THORACIC AORTIC DISEASE
MODERN METHODS FOR TREATING ABDOMINAL ANEURYSMS AND THORACIC AORTIC DISEASE AAA FACTS 200,000 New Cases Each Year Ruptured AAA = 15,000 Deaths per Year in U.S. 13th Leading Cause of Death 80% Chance of
More informationEXPERIENCE AFTER 500 ENDOLUMINAL STENT GRAFTS. DEVICES SPECIFIC OUTCOME AND LESSONS LEARNED.
EXPERIENCE AFTER 500 ENDOLUMINAL STENT GRAFTS. DEVICES SPECIFIC OUTCOME AND LESSONS LEARNED. A/Prof. B. Patrice Mwipatayi MD, MMed (Surg), MClinEd (Melb), FCS, FRACS Department of Vascular Surgery, Royal
More informationIs EVAS a proper choice in women?
Is EVAS a proper choice in women? CACVS 2018 Jan MM Heyligers, PhD, FEBVS Consultant Vascular Surgeon Elisabeth TweeSteden Hospital Tilburg The Netherlands Disclosures Consultant for Endologix DEVASS =Dutch
More informationAbdominal Aortic Aneurysms. A Surgeons Perspective Dr. Derek D. Muehrcke
Abdominal Aortic Aneurysms A Surgeons Perspective Dr. Derek D. Muehrcke Aneurysm Definition The abnormal enlargement or bulging of an artery caused by an injury or weakness in the blood vessel wall A localized
More informationThe Petticoat Technique Managing Type B Dissection with both Early and Long Term Considerations
The Petticoat Technique Managing Type B Dissection with both Early and Long Term Considerations Joseph V. Lombardi, MD Professor & Chief, Division of Vascular & Endovascular Surgery Department of Surgery,
More informationChimney endovascular aneurysm sealing (ch-evas) for ruptured abdominal aortic aneurysms (AAA) due to type Ia endoleak following failed EVAS
Chimney endovascular aneurysm sealing (ch-evas) for ruptured abdominal aortic aneurysms (AAA) due to type Ia endoleak following failed EVAS Saritphat Orrapin MD FRCS (Thailand), Thoetphum Benyakorn, Tunyarat
More informationSANWICH TECHNIQUE TO REDUCE COMPLICATIONS WHEN TREATING BILATERAL INTERNAL ILIAC ARTERY
SANWICH TECHNIQUE TO REDUCE COMPLICATIONS WHEN TREATING BILATERAL INTERNAL ILIAC ARTERY TRAN TRA GIANG.MD Interventional cardiovascular department Hanoi Heart Hospital, Hanoi, Viet Nam Nothing to Disclose
More informationNEW INNOVATIONS IN ENDOLEAK MANAGEMENT
DISCLOSURES NEW INNOVATIONS IN ENDOLEAK MANAGEMENT Kelley HodgkissHarlow, MD, RPVI, FACS Vascular and Endovascular Surgery Kaiser Permanente, San Diego Nothing to disclose GOALS BACKGROUND Background Surveillance
More informationEndovascular Aneurysm Sealing System for Treating Abdominal Aortic Aneurysms: Early Outcomes from a Single Center
Endovascular Aneurysm Sealing System for Treating Abdominal Aortic Aneurysms: Early Outcomes from a Single Center Thiti Chanmayka MD*, Anucha Ahooja MD**, Chalach Mitprachapranee MD*, Chawalit Wongbhuddha
More informationLessons learned from Ch-EVAR for the treatment of. Miltos Matsagkas MD, PhD, FEBVS Professor of Vascular Surgery University of Thessaly
Lessons learned from Ch-EVAR for the treatment of pararenal AAAs Miltos Matsagkas MD, PhD, FEBVS Professor of Vascular Surgery University of Thessaly Ch-EVAR Ch-EVAR = Chimney-EVAR Placement of single
More informationBifurcated system Proximal suprarenal stent Modular (aortic main body and two iliac legs) Full thickness woven polyester graft material Fully
Physician Training Bifurcated system Proximal suprarenal stent Modular (aortic main body and two iliac legs) Full thickness woven polyester graft material Fully supported by self-expanding z-stents H&L-B
More informationAbdominal Aortic Aneurysm 가천대길병원 이상준
Abdominal Aortic Aneurysm 가천대길병원 이상준 1 Definition Diameter of the aorta 1.5 times greater than normal. Most are infrarenal, and a significant number extend down into one or both iliac arteries Abdominal
More informationTreating very short necks ( 4mm <10mm) using the Endurant stent graft + EndoAnchors: 1-year results and current insights
Treating very short necks ( 4mm
More informationAnatomical challenges in EVAR
Anatomical challenges in EVAR M.H. EL DESSOKI, MD,FRCS PROFESSOR OF VASCULAR SURGERY CAIRO UNIVERSITY Disclosure Speaker name:... I have the following potential conflicts of interest to report: Consulting
More informationWhen to use standard EVAR with EndoAnchors or CHEVAR in short-neck AAAs LINC ASIA 18
When to use standard EVAR with EndoAnchors or CHEVAR in short-neck AAAs JEAN-PAUL P.M. DE VRIES, DIRECTOR OF VASCULAR SURGERY ST.ANTONIUS HOSPITAL NIEUWEGEIN, THE NETHERLANDS. LINC ASIA-PACIFIC HongKong,
More informationProspective Study of the E-liac Stent Graft System in Patients with Common Iliac Artery Aneurysm: 30-Day Results
Prospective Study of the E-liac Stent Graft System in Patients with Common Iliac Artery Aneurysm: 30-Day Results J. Brunkwall MD, Ph.D, FEBVS On behalf of the Pliant study groups E-liac Stent Graft System
More informationAccessi Iliaci Ostili
Alma Mater Studiorum Bologna University S.Orsola-Malpighi, Bologna, Italy Vascular Surgery Accessi Iliaci Ostili nel trattamento della patologia aortica E. Gallitto Iliac Navigations Alma Mater Studiorum
More informationLess Invasive EVAR Transitioning to a Fast-Track Protocol
Less Invasive EVAR Transitioning to a Fast-Track Protocol Mario Lachat, MD University of Zurich Department of Cardiovascular Surgery Switzerland LINC 2015 1 Disclosure Speaker name: Mario Lachat, MD I
More informationGORE EXCLUDER AAA Endoprosthesis demonstrates long-term durability. Michel Reijnen Rijnstate Hospital Arnhem, The Netherlands
GORE EXCLUDER AAA Endoprosthesis demonstrates long-term durability Michel Reijnen Rijnstate Hospital Arnhem, The Netherlands Disclosure Speaker name: Michel Reijnen I have the following potential conflicts
More informationChallenging anatomies demand versatility.
Challenging anatomies demand versatility. The Distinct Advantages of Separating Seal and Fixation ANATOMICAL FIXATION Unlike proximal fixation designs, the AFX bifurcated unibody endograft allows for natural
More informationObesity, Scaring, Access in EVAR. Kiskinis D, Melas N, Ktenidis K. 1 st Department of Surgery Aristotle University of Thessaloniki, Greece
Obesity, Scaring, Access in EVAR Kiskinis D, Melas N, Ktenidis K. 1 st Department of Surgery Aristotle University of Thessaloniki, Greece Obesity Decreased radiolucency (visibility) Max weight load < 160
More informationFrom 1996 to 1999, a total of 1,193 patients with
THE ANEURX CLINICAL TRIAL AT 8 YEARS Lessons learned following the US AneuRx clinical trial from 1996 to 2004. BY CHRISTOPHER K. ZARINS, MD From 1996 to 1999, a total of 1,193 patients with infrarenal
More informationWhat's on the Horizon for AAA: Unilateral & Percutaneous, "UP-EVAR" System Zoran Rancic M.D., Ph.D.
What's on the Horizon for AAA: Unilateral & Percutaneous, "UP-EVAR" System Zoran Rancic M.D., Ph.D. Clinic for Cardiovascular Surgery University Hospital Zurich DISCLOSURES COMMON SITUATIONS FOR UNILATERAL
More informationOff-the-Shelf Devices. Mark A Farber, MD FACS Director, Aortic Center Professor of Radiology and Surgery University of North Carolina
Off-the-Shelf Devices Mark A Farber, MD FACS Director, Aortic Center Professor of Radiology and Surgery University of North Carolina Disclosures Cook - Research Support, Consultant, Clinical Trials WL
More informationThe clinical update for the Zenith AAA Endovascular Graft has included results from the Zenith AAA Endovascular Graft multi-center clinical study,
The clinical update for the Zenith AAA Endovascular Graft has included results from the Zenith AAA Endovascular Graft multi-center clinical study, the 36 mm diameter Zenith Flex AAA Endovascular Graft
More informationRetrograde Embolization of a Symptomatic Hypogastric Artery Aneurysm
Retrograde Embolization of a Symptomatic Hypogastric Artery Aneurysm Andrew Unzeitig MD Piedmont Atlanta Hospital Georgia Vascular Society 2017 Annual Meeting Lake Oconee, Georgia Disclosures None Case
More informationTaming The Aorta. David Minion, MD Program Director, Vascular Surgery University of Kentucky Medical Center Lexington, Kentucky, USA
Taming The Aorta David Minion, MD Program Director, Vascular Surgery University of Kentucky Medical Center Lexington, Kentucky, USA Faculty Disclosure Consulting: Endologix, Cook 1 Objectives Review the
More informationEvolution of gender-related differences in outcome of EVAR
Evolution of gender-related differences in outcome of EVAR Erik Debing Department of Vascular Surgery University Hospital Brussels Disclosure Speaker name: ERIK DEBING... I have the following potential
More informationAn Overview of Post-EVAR Endoleaks: Imaging Findings and Management. Ravi Shergill BSc Sean A. Kennedy MD Mark O. Baerlocher MD FRCPC
An Overview of Post-EVAR Endoleaks: Imaging Findings and Management Ravi Shergill BSc Sean A. Kennedy MD Mark O. Baerlocher MD FRCPC Disclosure Slide Mark O. Baerlocher: Current: Consultant for Boston
More informationUltrasound Evaluation after EVAR: (Trying to) Let the CAT Scan Out of the Bag
Ultrasound Evaluation after EVAR: (Trying to) Let the CAT Scan Out of the Bag Joseph-Vincent V. Blas, MD Division of Vascular Surgery Department of Surgery Greenville Health System University of South
More informationEVAS Sealing Technology: The new paradigm in AAA therapy
June 2016 EDUCATIONAL SUPPLEMENT EVAS Sealing Technology: The new paradigm in AAA therapy This educational supplement has been supported by an unrestricted educational grant from Endologix MM1398 Rev 01
More informationRobert F. Cuff, MD FACS SHMG Vascular Surgery
Robert F. Cuff, MD FACS SHMG Vascular Surgery Objectives To become familiar with the commercially available fenestrated EVAR graft Discuss techniques to increase success Review available data to determine
More informationFEVAR FIFTEEN YEARS OF EFFICIENCY E.DUCASSE MD PHD FEBVS CHU DE BORDEAUX
FEVAR FIFTEEN YEARS OF EFFICIENCY E.DUCASSE MD PHD FEBVS CHU DE BORDEAUX 2018 A BIT OF HISTORY First use of F-EVAR : 1990s Park et al. J Vasc Interv Radiol. 1996;7:819-823. Faruqi et al. J Endovasc Surg.
More informationAAA: DEBATE THERE ARE NO LIMITS USING EVAR FOR AAA. 2 nd -3 rd June 2016.
AAA: DEBATE THERE ARE NO LIMITS USING EVAR FOR AAA JORGE FERNÁNDEZ NOYA ANGIOLOGY AND VASCULAR SURGERY DEPARTMENT UNIVERSITARY CLINICAL HOSPITAL SANTIAGO DE COMPOSTELA 2 nd -3 rd June 2016. 1888 ENDOANEURYSMORRHAPHY
More informationType 1a Endoleak in hostile neck anatomies: Endoanchor can fix it! D. Böckler University Hospital Heidelberg, Germany
Type 1a Endoleak in hostile neck anatomies: Endoanchor can fix it! D. Böckler University Hospital Heidelberg, Germany Disclosures Speaker name: Dittmar Böckler I have the following potential conflicts
More informationCase Report Early and Late Endograft Limb Proximal Migration with Resulting Type 1b Endoleak following an EVAR for Ruptured AAA
Hindawi Case Reports in Vascular Medicine Volume 2017, Article ID 4931282, 5 pages https://doi.org/10.1155/2017/4931282 Case Report Early and Late Endograft Limb Proximal Migration with Resulting Type
More informationEndoleaks after F-BEVAR How to Assess & Treat? Gustavo S. Oderich, MD Mayo Clinic Rochester, MN
Endoleaks after F-BEVAR How to Assess & Treat? Gustavo S. Oderich, MD Mayo Clinic Rochester, MN FACULTY DISCLOSURE Gustavo S. Oderich MD Consulting, DSMB, CEC* Cook Medical Inc., WL Gore, Lombardi Honoraria
More informationResidual Dissection and False Lumen Aneurysm After TEVAR
WHAT WOULD YOU DO? Residual Dissection and False Lumen Aneurysm After MODERATOR: MARK FARBER, MD PANEL: YAZAN DUWAYRI, MD; MATTHEW J. EAGLETON, MD; WILLIAM D. JORDAN Jr, MD; TILO KÖLBEL, MD, PhD; AND ERIC
More informationNow that Endoanchors are Approved (and paid for) We have a Durable Solution to Short Necks That s so Easy!
Now that Endoanchors are Approved (and paid for) We have a Durable Solution to Short Necks That s so Easy! David H. Deaton, MD Vascular Surgery / University of South Carolina / Palmetto Health Chief Medical
More informationHYPOGASTRIC ARTERY PRESERVATION DURING EVAR: SURGICAL AND ENDOVASCULAR TECHNIQUES Single Centre Experience. Ilaria Ficarelli
HYPOGASTRIC ARTERY PRESERVATION DURING EVAR: SURGICAL AND ENDOVASCULAR TECHNIQUES Single Centre Experience Ilaria Ficarelli Service of Vascular Surgery Cardarelli Hospital Naples Chief: Carlo Ruotolo,
More information