EVAS using Nellix in my practice Where are we today?

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1 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

2 Disclosures and Disclaimers Consultant, Endologix Presentation includes off-label and unapproved uses of Endologix device

3 Endovascular Aneurysm Repair Since its first implementation in 1991, EVAR has gained wide acceptance for the treatment of AAA After >25 years of experience there are still limitations and re-interventions; Endoleak Migration Component separation There are unsolved problems; Post-implant syndrome Inferior late survival compared to open surgery

4 Introducing a New Therapy EVAS is not EVAR Concept based on sealing the aneurysm sac with polymerfilled endobags, potentially disruptive technology Active sac management; No induction of fresh thrombus Reduction in the overall endoleak rate Impact on re-intervention rate

5 EVAS FORWARD Global Registry: Promising Early Results, Despite Pushing IFU Boundaries Endoleaks at 1y 37% Off Anatomic IFU Holden et al, EVAS FORWARD Global Registry: One Year Outcomes, November 19, Veith Symposium, New York The EVAS FORWARD Global Registry is a real-world post market study of the Nellix EndoVascular Aneurysm Sealing System where patients had vascular characteristics beyond the approved anatomic IFU. Safety and effectiveness of Nellix used off-ifu has not been established.

6 Enthusiasm Lessons Learned The sealing the entire aneurysm idea quite simply represents a very seductive concept that seems to lure the vascular surgeon beyond the IFU. Little to no neck? Angulated necks? Large necks?...all not a problem, the endobags will take care of it.the sky seems the limit.

7 EVAS Therapy: progression of the technique REFINED ANATOMIC IFU STANDARDIZED PROCEDURE EVOLUTION OF DEVICE

8 Dutch EndoVascular Aneurysm Sealing (DEVASS) Study Results IFU Revision 12 months 24 months The freedom from reinterventions IFU % 89.7% IFU % 95.7% The freedom from migration IFU % 89.9% IFU % 100% The freedom from all endoleaks IFU % 92.7% IFU % 90.1% Freedom from aneurysm growth IFU % 91.8% IFU % 89.3% Primary patency IFU % 94.0% IFU % 100%

9 M A T U R I T Y 1Y FREEDOM FROM ENDOLEAK, REINTERVENTION, RUPTURE 2Y EVENTS TYPE IA ENDOLEAK MIGRATION SAC GROWTH PROMISING RESULTS, DESPITE PUSHING IFU (GLOBAL REGISTRY) ROOT CAUSE ANALYSES Clinical Imaging Engineering Statistical FF TYPE II ENDOLEAK, RUPTURE, ARM, ACM IFU/PROCEDURE REFINED PREDICTABLE OUTCOMES 96% FF MIGRATION, TYPE IA, SAC GROWTH CONFIRMATORY TRIAL GEN2 NELLIX DEVICE RIGOROUS TRAINING BEST PRACTICES EXTERNAL CORE LAB CASE REVIEW BOARD PROCTORING DEDICATED CASE SUPPORT EU PEER-TO-PEER SECONDARY INT APPROVED A snapshot early in the learning curve, represents a predictable perspective EVAS EVOLVED ChEVAS IDE NEXT GEN EVAS ACM/CVM IDE: N=333, CONTROLLED GLOBAL REGISTRY: N=300, ALL-COMERS (37% OFF-IFU) TIME

10 EVAS2: Validating Freedom from Adverse Events when Anatomically On-IFU / Procedurally On-Target* Freedom from Migration >10mm Freedom from Aneurysm Enlargement Freedom from Type Ia Endoleak * * * 12 Mo 24 Mo 36 Mo 100% 98.6% 98.6% 12 Mo 24 Mo 36 Mo 100% 98.6% 96.9% 12 Mo 24 Mo 36 Mo 100% 98.6% 98.6% Freedom from Aneurysm Related Mortality 100% through 3 years Retrospective analysis of EVAS FORWARD IDE patient cohorts. Data on file at Endologix, Office of Clinical Affairs

11 EVAS in my Practice: Reduce Type II Endoleak

12 EVAS in my Practice: Complex AAA with ChEVAS Nellix with ChEVAS is not approved in any geography for sale or investigation. Safety and effectiveness of off-label use of Nellix has not been confirmed or approved.

13 EVAS in my Practice: EVAS for EVAR Repair Type 1A Endoleak Repair Type 3A Endoleak Repair Type 3B Endoleak Repair Excluder Anaconda Endurant Renu Courtesy of Francesco Torella, MD Liverpool, UK Courtesy of JP de Vries, MD, PhD Nieuwegein, NL Courtesy of Michel Reijnen, MD, PhD Arnhem, NL Courtesy of Rob Fischer, MD Liverpool, UK Expanding population as EVAR prevalence manifests Nellix for EVAR Repair is not approved in any geography for sale or investigation. Safety and effectiveness of off-label use of Nellix has not been confirmed or approved.

14 EVAS in my Practice: EVAS for EVAS Revision Caudal Migration at 2 years Nellix-in-Nellix Extension with Renal Stents Nellix for EVAS Repair is not approved in any geography for sale or investigation. Safety and effectiveness of off-label use of Nellix has not been confirmed or approved.

15 Systemic Inflammatory Response Syndrome (SIRS) EVAR and EVAS EVAS (63) EVAR (41) PIS (%) CRP (mg/l) WCC MAE (%) Cardiac MAE 0 11 Endoleaks Berg et al. JEVT 2017; 24: 670 Stenson et al Veith 2017 (106) (123) The Nellix EndoVascular Aneurysm Sealing System has not been studied in a prospective head-to-head clinical study against other EVAR devices

16 EVAR and EVAS Mechanisms EVAR EVAS

17 EVAS vs EVAR All Cause Mortality SVS VQI Propensity-Weighted Analysis 41% lower risk of mortality for EVAS AAA 5.5 cm, 50% lower risk of mortality for EVAS 93% EVAS 88% EVAR 92% EVAS 86% EVAR Schermerhorn et al. Presented at the Charing Cross Symposium, April 2018, London, UK The Nellix EndoVascular Aneurysm Sealing System has not been studied in a prospective head-to-head clinical study against other EVAR devices

18 INSPIRE Prospective Study of EVAR and EVAS Investigation on Aneurysm Sealing to Prevent Inflammatory Response Control: Comparison of EVAS to Dacron EVAR grafts (Endurant, Zenith) 60 patients, each group. 4 countries: UK, Netherlands, Germany, Poland Labs: pre- and post-op, 30d, and through 12 month follow-up Cytokines, Cardiac biomarkers (CRP, WBC, Troponin, BMC, CMP) Clinical Outcomes: Adverse Events, Endoleak, Device-Related Reintervention, All-Cause and CV Mortality Enrollment in progress

19 Summary New therapy, conceptually different to EVAR Active Sac Management Rapid EU adoption and lessons learned EVAS evolved: IFU revision / procedure refinement / improvement in design Early evidence of EVAS vs. EVAR: less PIS and lower all-cause mortality Therapy deserves continued evolution

20 INDICATIONS FOR USE: The Nellix EndoVascular Aneurysm Sealing System can be used in patients who have an infrarenal abdominal aortic or aortoiliac aneurysm (AAA) with suitable anatomy as indicated: Iliac and femoral artery access that allows for atraumatic device introduction, aortic proximal neck diameter range of 18mm to 28mm, minimum aortic proximal neck length 10mm, with diameter change 10%, proximal aortic neck angulation of 60, aortic aneurysm with a blood lumen diameter 60mm, ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.4, iliac artery inner wall diameter range of 9mm to 20mm, and distal seal zone with length of 10mm and diameter range of 9mm to 20mm CONTRAINDICATIONS: The Nellix EndoVascular Aneurysm Sealing System is contraindicated for patients who have a condition that threatens to infect the implant and patients with sensitivities or allergies to the implant materials. Note: Nellix System components (Catheter delivery and Implant) are not made with natural rubber latex. CAUTION: The Nellix EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only. The Nellix EndoVascular Aneurysm Sealing System has not been approved in any geography for treatment of juxta/pararenal aneurysm.