Heli-FX™

EndoAnchor™ System

ANCHOR Objective: Capture post-commercial availability usage and long term outcomes of ESAR (EndoSuture Aneurysm Repair) with Heli-FX™ EndoAnchor™ System

ANCHOR ANEURYSM TREATMENT USING THE HELI-FX™ ENDOANCHOR™ SYSTEM GLOBAL REGISTRY

Design: Post-market, prospective, multi-arm registry

Enrollment: Up to 1200 patients followed for 5-years

Devices Include: Medtronic Endurant™, Talent™ and AneuRx™ grafts; Gore Excluder™* grafts and Cook Zenith™* grafts

Principal Investigators:

United States: Dr. William Jordan – Chief of Vascular Surgery/ Endovascular Therapy, Emory University School of Medicine, Atlanta, Georgia

Europe: Dr. Jean-Paul de Vries – Chair of Department of Surgery, University Medical Center Groningen, the Netherlands

ANCHOR REGISTRY

ANCHOR ENROLLMENT (ABDOMINAL ARM)

ENROLLMENT STATUS1

Patients since 2012 >950

Countries ANZ, US and EU

Sites 95

REVISION ARM

26%

PRIMARY ARM

74%

ANCHOR REGISTRY1

61% Medtronic Endurant™

27% Gore Excluder™*

10% Cook Zenith™*

2% Other

Stent Grafts - Primary Arm

57.3% Concern for Late Failure21.9% Prevention of Neck Dilatation20.1% Treatment of Type Ia at Index

87.9% ASA Class III/IV18.2% Urgent/Emergent Cases

Reasons for ESAR

We are observing that patients treated prophylactically with ESAR are seeing the most therapeutic benefit, which tells us that EndoAnchor™ implants are an opportunity for EVAR improvement in patients at risk for disease progression.

- Dr. William Jordan ANCHOR Co-Principal Investigator

™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 1 June 2019

CONCLUSIONS ANCHOR captures post-commercial availability use of the Heli-FX™ system with primarily Medtronic grafts, Gore Excluder™*grafts and Cook Zenith™* grafts

Majority of patients enrolled have met the Society for Vascular Surgery analysis criteria for hostile neck

By recreating the durability of a sutured anastomosis, ESAR protects against neck dilatation and promotes sac regression, which has shown to predict better long-term survival5-7

Infrarenal Diameter:23.9 mm

InfrarenalAngulation:36.6°

Neck Length (median):15.0 mm

Conical Neck(>10%/10 mm):41.7%

Max AneurysmDiameter: 59.0 mm

β

88.6% of prophylactic ANCHOR patients4 have “hostile” neck characteristics as defined by Society for Vascular Surgery guidelines (N=530 out of 598)

POST-COMMERCIAL AVAILABILITY OUTCOMES2

4 year results for N=716 patients treated with ESAR at index EVAR

Patients with decreasing aneurysm sac (64/103)

62.1%

Type Ia Endoleak (4/117)3

3.4%Migration (0/57)0%EndoAnchor™ Implants Adequately Penetrated Aorta (683/712)

95.9%

2Based on June 2019 data cut32 patients with 4mm infrarenal thrombus (outside Heli-FX™ EndoAnchor™ implant IFU recommendation). One patient with graft misdeployment and persistent type Ia endoleak4Baseline characteristics and aneurysm measurements are mean (or unless otherwise indicated) based on 598 patients with baseline CTs 5 Melas N, Perdikides T, Saratzis A, Saratzis N, Kiskinis D, Deaton DH. Helical endostaples enhance endograft fixation in an experimental model using human cadaveric aortas. J Vasc Surg.June 2012;55(6):1726-1733.

6Muhs BE et al. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors J Vasc Surg. June 2018 67(6):1699-1707. 7 Muhs BE. In Patients With Hostile Neck Anatomy EndoAnchors Prevent Endoleaks And Migration: A Propensity Matched Comparison Of EVAR In Hostile Neck Patients w/ and w/o EndoAnchors Presented at Veith; November 2016; New York, NY

UC201700318d EN © 2019 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. For distribution in the USA only. 12/2019

medtronic.com/aortic

HELI-FX™ ENDOANCHOR™ SYSTEMIndications for Use: The Heli-FX™ EndoAnchor™ system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX™ EndoAnchor™ system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor™ implant may be implanted at the time of the initial endograft placement, or during a secondary (i.e. repair) procedure.Contraindications: Treatment with the Heli-FX™ EndoAnchor™ system is contraindicated for use in the following circumstances: • In patients with known allergies to the EndoAnchor™ implant material (MP35N-LT) • In conjunction with the Endologix Powerlink™* endograft Warnings: • The long-term performance of the EndoAnchor™ implant has not been established. All patients should be advised endovascular aneurysm treatment requires long-term, regular follow-up visits to assess the patient’s health status and endograft performance. The EndoAnchor™ implant does not reduce this requirement. • The EndoAnchor™ implant and the Heli-FX™ EndoAnchor™ system have been evaluated via in vitro

testing and determined to be compatible with the Cook Zenith™*, Cook Zenith™* TX2™*, Gore Excluder™*, Gore TAG™*, Medtronic AneuRx™, Medtronic Endurant™, Medtronic Talent™ AAA, Medtronic Talent™ TAA, Medtronic Valiant Xcelerant™, Medtronic Valiant™ Captivia™, and Medtronic Valiant Navion™ endografts. Use with endografts other than those listed above has not been evaluated.

• The performance of the EndoAnchor™ implant has not been evaluated for securing multiple endograft components together. Not securing EndoAnchor™ implants into aortic tissue could result in graft fabric damage, component separation, and resultant Type III endoleaks.

• The performance of the EndoAnchor™ implant has not been evaluated in vessels other than the aorta. Use of the EndoAnchor™ implant to secure endografts to other vessels may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures.

• The performance of the EndoAnchor™ implant has not been evaluated for securing multiple anatomical structures together. Such use could result in adverse patient consequences such as vascular perforation, bleeding, or embolic events.

MRI Safety and Compatibility: • The EndoAnchor™ implants have been determined to be MR Conditional at 3T or less when the scanner is in Normal Operating Mode with whole-body-averaged SAR of 2 W/kg, or in First Level Controlled Mode with a maximum whole-body-averaged SAR of 4 W/kg.• Please refer to documentation provided by the endograft system manufacturer for MR safety status

of the endograft system with which the EndoAnchor™ implants are being used.

Potential Adverse Events: Possible adverse events that are associated with the Heli-FX™ EndoAnchor™ system, include, but are not limited to: • Aneurysm rupture • Death • EndoAnchor™ implant embolization • Endoleaks (Type III) • Enteric fistula • Failure to correct/prevent Type I endoleak • Failure to prevent endograft migration • Infection • Renal complications (renal artery occlusion/dissection or contrast-induced acute kidney injury) • Stroke • Surgical conversion to open repair • Vascular access complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula • Vessel damage, including dissection, perforation, and spasm Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. Additional potential adverse events may be associated with endovascular aneurysm repair in general. Refer to the Instructions for Use provided with the endograft for additional potential adverse events.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information.

CAUTION: EndoAnchor™ implant locations should be based upon a detailed examination of the preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing zones. EndoAnchor™ implants should be implanted only into areas of aortic tissue free of calcified plaque or thrombus, or where such pathology is diffuse and less than 2mm in thickness. Attempting to place EndoAnchor™ implants into more severe plaque or thrombus may be associated with implantation difficulty and suboptimal endograft fixation and/or sealing.

Sac regression predicts improved long-term survival. Analysis of 1,802 EVARs demonstrated that patients with sac regression experienced significantly higher long term survival than patients with AAA sac diameters that remained stable or expanded.1

ESAR (EndoAnchor Aneurysm Repair) had significantly greater sac regression as compared to EVAR alone at 2 year post-op (81% vs. 49% without EndoAnchor™ fixation, p=.01)2

Heli-FX™ EndoAnchor™ implants promote sac regression in ANCHOR primary prophylactic cohort. Through 4 years, ANCHOR patients show positive sac regression despite hostile anatomy characteristics.

SAC BEHAVIOR AND SURVIVAL1

P value = 0.01 at 2 years

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Years

1.00

0.75

0.50

0.25

0.00

Pro

port

ion

Sur

vivi

ng

— Regression— Stable— Expansion

P < .01 for all comparisons. SE < 0.1

Long-Term Survival

CUMULATIVE SAC REGRESSION2

0 120 240 360 480 600 720 840

Days Postoperative

1.0

0.8

0.6

0.4

0.2

0.0

Cum

ulat

ive

Sac

Reg

ress

ion — EndoAnchor™ fixation

81.1% ± 9.5%— Control

48.7% ± 5.9%

P value = 0.01 at 2 years

PRIMARY PROPHYLACTIC SAC BEHAVIOR IN ANCHOR

Enlargement Stable Regression

20%

60%40%

80%100%

0%1-Year

(443)2-Year

(266)3-Year

(182)4-Year

(103)

38% 52% 51%62%

(N)

A MORE COMPETENT PROXIMAL SEAL POTENTIALLY INDUCES AAA REMODELING, WHICH COULD BENEFIT LONG-TERM SURVIVAL

1 O’Donnell TFX, Deery SE, Boitano, LT. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. Feb 2018;69(2):414-422

2 Muhs BE et al. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors J Vasc Surg. June 2018 67(6):1699-1707

This therapy is not for everyone. Please consult your physician. A prescription is required. For further information, please call Medtronic at +1.888.283.7868.