14F OD Ovation Abdominal Stent Graft System
|
|
- Julia Cox
- 6 years ago
- Views:
Transcription
1 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
2 Disclosure Within the last 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organizations listed below. Advisory Board /Consultant: Abbott, Angioslide, Atheromed, Biotronik, Boston Scientific, Cook Medical, Cordis, Covidien, CR Bard, Gardia Medical, Medtronic, TriReme Medical, Trivascular, Upstream Peripheral Technologies Stockholder/ Consultant: IDEV Technologies
3 Why Another EVAR Device?
4 Problems with Commonly Used Stent Grafts Narrow and tortuous iliac arteries preclude access to treatment area Hostile necks, thrombus and calcium prevent an effective seal
5 Ovation Abdominal Stent Graft Suprarenal nitinol stent with anchors for fixation 14F OD Aortic Body filled with a lowviscosity, radiopaque, fill polymer Tri-modular design Inflatable rings for optimal seal 13-14F OD conformable iliac limbs
6 TriVascular Abdominal Study A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System Primary Safety Endpoint: MAE within 30 days of the procedure, as determined by Clinical Events Committee Primary Performance Endpoint: Treatment success defined as: Successful Delivery and Deployment Freedom from rupture, and conversion to open surgical repair Freedom from Type I and III endoleaks, migration, enlargement, as determined by Core Lab Follow-up: 1 month, 6 month and annual to 5 years
7 Selected Inclusion Criteria AAA 5.0 cm in diameter or 5.0 cm in diameter if: Ø increased 5 mm in 6 months Ø is 1.5 times normal aortic diameter Proximal neck: 7 mm in length 16 to 30 mm in diameter (ID) 45 angle (neck < 10 mm) 60 angle (neck 10 mm) Distal Iliac landing zone of: 10 mm in length 8 to 20 mm diameter (ID) Overall length from renal to hypo 130 mm Adequate iliac/femoral access compatible with the required delivery systems
8 EU Enrolling Institutions SITE LOCATION SITE PI SUBJECTS Herz-und Gefässzentrum Bad Bevensen Nolte 12 Uni. Klinik Köln Köln Brunkwall 1 Medical Care Center Prof Mathey Prof Schofer Hamburg Krankenberg 6 Klinikum Dortmund Dortmund Mathias 2 Park Krankenhaus Leipzig Scheinert 2 Sankt Katharinen Frankfurt Sievert 5 St. Franziskus-Hospital Münster Torsello 2
9 Patient Demographics PATIENT PROFILE Age Mean, (SD) 71.9, (6.5) Gender Male 90.0% CO-MORBIDITIES Coronary Artery Disease 33.3% (10/30) Valvular Heart Disease 10.0% (3/30) Previous MI 16.7% (5/30) Hypertension 73.3% (22/30) Hyperlipidimia 46.7% (14/30) PVD 13.3% (4/30) Smoker 60.0% (18/30) Other Significant Medical Condition 66.7% (20/30)
10 Anatomical Characteristics Aortic Neck Length (n=30) 23% of treated aortic necks shorter than 15mm % were < 10mm in length <10 mm mm mm mm 25 mm Minimum Access Vessel Diameter (n=30) 47% of patients treated had an access vessel < 7mm in diameter Minimum diameter access vessel treated = 3.2mm mm 6.1-7mm mm >8 mm
11 Procedure Characteristics PROCEDURE DATA Total Procedure Time (min) Mean +/- (SD) 107 (50) Device Time (min) Mean +/- (SD) 47 (34) Procedural Blood Loss (ml) Mean +/- (SD) 142 (137) ANESTHESIA* General Anesthesia 53% 16/30 Regional Anesthesia 7% 2/30 Local or Conscious Sedation 50% 15/30 PRIMARY VESSEL ACCESS Percutaneous 57% Cut Down 47% Cut Down & Percutaneous 3% * Some patients received more than one type of anesthesia.
12 Primary Safety Based on Clinical Events Committee (CEC) adjudicated data SAFETY 0-30 Days Days Major Adverse Events 0% (0) 10% (3) Device Related Major Adverse Events 0% 0% All Cause Mortality 0% 6.6% (2) MAEs at 1 year: 1 subject with myocardial infarction 1 subject with death due to suspected TAA rupture 1 subject with GI hemorrhage and death
13 Performance Based on Core Lab Data (M2S results) PERFORMANCE 30 Day 1 Year 2 Year Technical Success 100% N/A N/A Freedom from Type I and III Endoleaks 100% 100% 100% Freedom from Migration 100% 100% 100% Freedom from Rupture 100% 100% 100% Freedom from Conversion to Open Repair 100% 100% 100% ANEURYSM ASSESSMENT 30 Day 1 Year 2 Year Enlargement >5mm Baseline 4% (1/27) 4% (1/25) No change Baseline 70.4% (19/27) 60%(15/25) Reduction >5mm Baseline 26%(7/27) 36% (9/25) One aneurysm enlargement >5mm was observed at 6 months, persisting at 1 year follow up (stable) and with regression to baseline diameter at 2 years follow up. Investigator reported a type II endoleak in this patient. One aneurysm enlargement >5mm was observed at 2 year for one subject. Investigator reported a type II endoleak in this patient. Patient has undergone reintervention and with stable outcome as a result.
14 Patients (%) Sac Regression at 2 years 100,0 90,0 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 89,0 70,0 60,0 4,0 4,0 4,0 7,0 6 Month 1 Year 2 years 36,0 26,0 Enlargement >5 mm No Change Reduction >5mm Core Lab reported one aneurysm enlargement >5mm at 6 months, persisting at 1 year follow up (stable) and with regression to baseline diameter at 2 years follow up. Investigator reported a type II endoleak in this patient. Core Lab reported one aneurysm enlargement >5mm at 2 year for one subject. Investigator reported a type II endoleak in this patient.
15 Expanding EVAR Safely
16 Case Example Access & Seal in Challenging Anatomy Anatomical Measurements: Neck Length: 9 mm Aortic Diameter: 26 mm Juxtarenal Angulation: 15 O AAA Diameter: 7.3 cm Access Vessel Diameter: 7 mm (L) / 7 mm(r) Technical Aspects: Kinking Access Vessels Infrarenal Angulation Devices Used: Aortic Body: 34 mm Right Iliac Limb: 18 x 140 mm Left Iliac Limb: 18 x 140 mm Image courtesy of Dr T Nolte, Bad Bevesen
17 Hostile Neck - Difficult Access:
18 12 m f/u:
19 Access & Seal in Challenging Anatomy 2 yr Follow Up Pre-Op 2 year f/u Maximum Sac Diameter Baseline (30d) = 63.3mm 2 yr follow-up = 55.3mm 2 yr sac reduction = 8mm
20 Clinical and Regulatory Status OVATION CE Mark received August 2010 OVATION PRIME CE Mark received June 2012 Enrolling in a 500 patient European post market registry Excellent year results across a clinically challenging cohort of patients Over 1,300 patients treated worldwide FDA PMA Approval, OVATION, October, 2012 FDA PMA-S Approval, OVATION PRIME, December 2012
21 Why Another EVAR Device... Ovation safely and effectively addresses previously unmet clinical needs Ovation s IFU expands the pool of patients eligible for EVAR Ovation is next generation EVAR technology available TODAY
22 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
Ovation. 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 informationOvation 4-Year Results Pivotal Study to Evaluate the Safety and Effectiveness of the Ovation System
Ovation 4-Year Results Pivotal Study to Evaluate the Safety and Effectiveness of the Ovation System Vascular Health Partners Glens Falls, New York Disclosure Speaker name: I have the following potential
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 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 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 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 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 informationOVATION: Custom Neck Seal that Benefits you and your Patients, Sustained by Long-term Data
OVATION: Custom Neck Seal that Benefits you and your Patients, Sustained by Long-term Data Disclosures Speaker name: Lieven F. Maene, MD I have the following potential conflicts of interest to report:
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 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 informationNellix Endovascular System: Clinical Outcomes and Device Overview
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
More informationThe Illumina FIH study with a next generation DES 12-months results
The Illumina FIH study with a next generation DES 12-months results Dierk Scheinert, MD Head of Medical Department V - Angiology University of Leipzig Medical Center, Germany Disclosure Dierk Scheinert,
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 informationTreating very short necks ( 4mm <10mm) using the Endurant stent graft + EndoAnchors: 1-year results and current insights
Treating very short necks ( 4mm
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 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 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 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 informationCOMPARE-Pilot RCT: 1-year results of a randomised comparison of RANGER DCB vs. IN.PACT DCB in complex SFA lesions. Dierk Scheinert
COMPARE-Pilot RCT: 1-year results of a randomised comparison of RANGER DCB vs. IN.PACT DCB in complex SFA lesions Dierk Scheinert Department of Angiology University Hospital Leipzig, Germany Disclosure
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 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 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 informationFeasibility of aortic neck anatomy for endovascular aneurysm repair in Korean patients with abdominal aortic aneurysm
LINC 2019 Leipzig, Germany Feasibility of aortic neck anatomy for endovascular aneurysm repair in Korean patients with abdominal aortic aneurysm Deokbi Hwang, Sujin Park, Hyung-Kee Kim, Seung Huh Division
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 informationRotarex mechanical debulking: The Leipzig experience in patients
Rotarex mechanical debulking: The Leipzig experience in 1.200+ patients Dierk Scheinert, MD Division of Interventional Angiology University-Hospital Leipzig, Germany Disclosure Speaker name: Dierk Scheinert
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 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 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 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 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 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 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 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 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 information2014 ANNUAL CLINICAL UPDATE. TriVascular Inc. Ovation and Ovation Prime Abdominal Stent Graft Systems
2014 ANNUAL CLINICAL UPDATE TriVascular Inc. Ovation and Ovation Prime Abdominal Stent Graft Systems 2014 ANNUAL CLINICAL UPDATE TriVascular Inc. Ovation and Ovation Prime Abdominal Stent Graft Systems
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 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 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 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 informationUpdate on the Levant 2 Clinical Trial Programme. Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany
Update on the Levant 2 Clinical Trial Programme Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany Disclosure Speaker name: Dierk Scheinert I have the following potential conflicts of interest
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 informationInsights from the PROTAGORAS/PERICLES Registries: impact on ChEVAR results
Insights from the PROTAGORAS/PERICLES Registries: impact on ChEVAR results Konstantinos P. Donas, Giovanni Torsello Department of Vascular Surgery St. Franziskus Hospital Münster, Germany Disclosure Speaker
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 informationStandardization of the CHEVAR procedure: How a standard approach has improved outcomes. Prof Peter Holt St George s, London
Standardization of the CHEVAR procedure: How a standard approach has improved outcomes Prof Peter Holt St George s, London Disclosure Speaker name: Prof Peter Holt I have the following potential conflicts
More informationDierk Scheinert, MD. Department of Angiology University Hospital Leipzig, Germany
The RANGER clinical trial programme: 12-month results from the RANGER RCT and first look at the COMARE I study of RANGER vs. IN.PACT for femoropopliteal lesions Dierk Scheinert, MD Department of Angiology
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 informationLatest Insights from the LEVANT II study and sub-group analysis
Latest Insights from the LEVANT II study and sub-group analysis Prof. Dr. med. Dierk Scheinert Division of Interventional Angiology University-Hospital Leipzig, Germany Conflicts of Interest Advisory Board
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 informationDurable outcomes. Proven performance.
Durable outcomes. Proven performance. GORE EXCLUDER AAA Endoprosthesis GORE EXCLUDER Iliac Branch Endoprosthesis GORE EXCLUDER AAA Endoprosthesis The most-studied* EVAR stent graft designed for durable
More informationConsiderations for a Durable Repair
Considerations for a Durable Repair Eric Verhoeven, MD, PhD, A. Katsargyris, MD Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany Disclosures William Cook
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 informationRISULTATI A DISTANZA DELL ENDOPROTESI OVATION
RISULTATI A DISTANZA DELL ENDOPROTESI OVATION SONIA RONCHEY MD PhD SAN FILIPPO NERI - ROMA MM1312 Rev 02 2016 Endologix, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order
More informationRight Choice for Right Angles
Right Choice for Right Angles The Anatomy of Technology Aorfix gives you technology that conforms to patient anatomy, optimising both procedure and post-operative performance. Fishmouth for optimum neck
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 informationReal PTX RCT: 3 year data from a randomized comparison of DCB vs. DES in femoropopliteal lesions
Real PTX RCT: 3 year data from a randomized comparison of DCB vs. DES in femoropopliteal lesions Dierk Scheinert, MD Department of Angiology University of Leipzig, Germany Disclosure Dierk Scheinert, MD
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 informationRotarex mechanical thrombectomythe first line option for thrombotic occlusions?
Rotarex mechanical thrombectomythe first line option for thrombotic occlusions? Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany Disclosure Advisory Board /Consultant:
More informationAorfix Pythagoras US Clinical Trial:
Overall 1 Year Results from the Aorfix Pythagoras US Clinical Trial: 1 st IDE Study in Highly Angulated 60 133 Aortic Necks Mark Fillinger MD for the PYTHAGORAS Investigators Disclosure Speaker name: Mark
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 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 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 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 informationFROM THE EVERYDAY TO THE EXTRAORDINARY
FROM THE EVERYDAY TO THE EXTRAORDINARY Created with the collaboration of more than 250 physicians around the world, ENDURANT empowers you to create stronger outcomes for more patients, including those
More informationZenith Renu AAA Converter Graft. Device Description Planning and Sizing Deployment Sequence Patient Follow-Up
Zenith Renu AAA Converter Graft Device Description Planning and Sizing Deployment Sequence Patient Follow-Up Device description: Device indications The Zenith Renu AAA Converter Graft with Z-Trak Introduction
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 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 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 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 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 informationThe evolution. AORFIX AAA Stent Graft now with the new AORFLEX Delivery System
The evolution of AORFIX AORFIX AAA Stent Graft now with the new AORFLEX Delivery System The confident choice for the right angles AORFIX the only AAA stent graft approved for all angulations from 0 90,
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 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 informationMid-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 informationGORE EXCLUDER AAA Endoprosthesis ANNUAL CLINICAL UPDATE OCTOBER Section I Clinical experience. Section II Worldwide commercial experience
GORE EXCLUDER AAA Endoprosthesis ANNUAL CLINICAL UPDATE OCTOBER 2018 Abstract This annual clinical update provides a review of the ongoing experience with the GORE EXCLUDER AAA Endoprosthesis used in the
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 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 informationLow profile TEVAR: is it an added value? Michel Bosiers, G. Torsello Münster
Low profile TEVAR: is it an added value? Michel Bosiers, G. Torsello Münster Disclosure Speaker name:...michel Bosiers... I have the following potential conflicts of interest to report: Consulting Employment
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 informationChallenges in the treatment of infrarenal aneurysm & considerations for a durable repair
Challenges in the treatment of infrarenal aneurysm & considerations for a durable repair Nilo J Mosquera, MD. Head of Department Angiology and Vascular Surgery. CHUO Hospital. Ourense. Spain Disclosure
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 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 informationLong-term results with interwoven nitinol stents vs. BMS vs. DCB
Long-term results with interwoven nitinol stents vs. BMS vs. DCB Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany Disclosure Advisory Board /Consultant: Abbott,
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 informationHow to Categorize the Infrarenal Neck Properly? I Van Herzeele Dept. Thoracic and Vascular Surgery, Ghent University, Belgium
How to Categorize the Infrarenal Neck Properly? I Van Herzeele Dept. Thoracic and Vascular Surgery, Ghent University, Belgium Disclosure Speaker name: Isabelle Van Herzeele I have the following potential
More informationLIFESTREAM TM First look at the BOLSTER 2-year follow up data
LIFESTREAM TM First look at the BOLSTER 2-year follow up data Dierk Scheinert, MD, on behalf of the Investigators Department of Angiology University Hospital Leipzig, Germany Disclosure Dierk Scheinert,
More informationThe Lutonix BTK Clinical Trial Programme: Status Update and Real World Clinical Experience
The Lutonix BTK Clinical Trial Programme: Status Update and Real World Clinical Experience Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany Disclosure Speaker name: Dierk Scheinert I have
More informationIncreased Flexibility of AneuRx Stent-Graft Reduces Need for Secondary Intervention Following Endovascular Aneurysm Repair
583 Increased Flexibility of AneuRx Stent-Graft Reduces Need for Secondary Intervention Following Endovascular Aneurysm Repair Frank R. Arko, MD; W. Anthony Lee, MD; Bradley B. Hill, MD; Paul Cipriano,
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 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 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 informationWhat does the data tell us about outcomes of EVAR in challenging anatomy?
What does the data tell us about outcomes of EVAR in challenging anatomy? UCSF Vascular Surgery Symposium 2018 Sukgu M Han, MD, MS Assistant Professor of Clinical Surgery Co-director, Comprehensive Aortic
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 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 informationPerformance of the conformable GORE TAG device in Type B aortic dissection from the GORE GREAT real world registry
University of Milan Thoracic Aortic Research Center Performance of the conformable GORE TAG device in Type B aortic dissection from the GORE GREAT real world registry Santi Trimarchi, MD, PhD Associate
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 informationSanti Trimarchi, MD, PhD Vascular Surgeon Thoracic Aortic Research Center, Director IRCCS Policlinico San Donato University of Milan
The Gore GREAT Registry: Update about a real life data collection Santi Trimarchi, MD, PhD Vascular Surgeon Thoracic Aortic Research Center, Director IRCCS Policlinico San Donato University of Milan Disclosures
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 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 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 information