Indications for use. Contraindications within the United States

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2 Indications for use Indications within the United States The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta, including: Isolated lesions in patients who have appropriate anatomy, including: Adequate iliac / femoral access Aortic inner diameter in the range of mm 20 mm non-aneurysmal aorta proximal and distal to the lesion Type B dissections in patients who have appropriate anatomy, including: Adequate iliac / femoral access 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected Diameter at proximal extent of proximal landing zone in the range of mm Contraindications within the United States Patients with known sensitivities or allergies to the device materials Patients who have a condition that threatens to infect the graft

3 Indications for use Indications under CE Mark in Europe The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta Contraindications under CE Mark in Europe Patients with known sensitivities or allergies to the device materials Patients with a systemic infection who may be at increased risk of endovascular graft infection

4 Table of contents The science behind the Conformable GORE TAG Thoracic Endoprosthesis Device attributes Partially uncovered stent Radial force Oversizing window Now FDA approved for dissection Clinical studies Treatment considerations Features and benefits Required ancillary devices Summary

5 The science behind the conformable GORE TAG Thoracic Endoprosthesis

6 Extensive research behind the design Design input from the GORE TAG Thoracic Endoprosthesis Maintain the established performance and durability of the GORE TAG Device Research to support the enhanced conformable design Peak blood flow velocity in the thoracic aorta varies dramatically with patient age Aortic diameters shown to increase with patient age Need for a conformable thoracic endograft to meet a broad range of anatomies

7 Peak blood flow velocity in the thoracic aorta varies dramatically with patient age Physiologic research studying the peak blood flow velocity in the thoracic aorta helped Gore understand the need for a thoracic endograft to optimize wall apposition and radial force over a wide range of aortic flow velocities Younger patients can have a peak blood flow velocity that is twice that of an older patient 250 Peak velocity, peak exercise, Vpk (cm / s) > 60 Salmasi AM, Doré C. Variation of aortic blood velocity with age at rest and during exercise in normal subjects. Clinical Autonomic Research 1995;5(1): Age

8 Aortic diameters shown to increase with patient age Anatomical research studying aortic diameters showed that mean thoracic vessel diameter increased with patient age. 33 Vessel diameter descending aorta (mm) > 60 H-U Kauczor, MD, PhD, unpublished data, July Age

9 Need for a conformable thoracic endograft to meet a broad range of anatomies Understanding the peak velocity and aortic diameter range within each age group provided important design inputs. Anatomic and physiological range of a healthy 25-year-old Higher peak velocity ~ 190 cm / s Aortic diameter ~ 20 mm Peak velocity Anatomic and physiological range of a healthy 65-year-old Lower peak velocity ~ 120 cm / s Aortic diameter ~ 25 mm Reported values represent mean Vessel diameter

10 Extensive clinical research to understand various thoracic etiologies We continue our commitment to clinical research and have incorporated data from various studies including the TAG High Risk Study (Complex Pathologies of the Descending Thoracic Aorta) into the design process for the device. Aneurysm 70-year-old patient Dissection 50-year-old patient Trauma 25-year-old patient

11 Indicated for all lesions of the Descending Thoracic Aorta (DTA) We worked with FDA to conduct three clinical trials to study the use of the Conformable GORE TAG Device in aneurysms, traumatic transections, and acute complicated Type B dissections TAG Aneurysm Study led to FDA approval for DTA aneurysms in August 2011 TAG Traumatic Transection Study led to FDA approval for isolated lesions of the DTA in January 2012 TAG Acute Complicated Type B dissection Study led to FDA approval for Type B dissections in September 2013 With safety and effectiveness shown with these three studies, and a pending post-approval study to further study Type B dissections, the FDA granted an indication for all lesions of the DTA including isolated lesions and Type B dissections (acute and chronic)

12 Device attributes

13 Conformability without compromise Conformable GORE TAG Thoracic Endoprosthesis is designed for conformability in tortuous anatomy and optimal wall apposition in angulated arch anatomy without excessive radial force, barbs or bare springs. Partially uncovered stent: helps achieve 360 aortic wall apposition in angulated anatomy without barbs or bare springs Radial force: targeted and consistent radial force maintains wall apposition in angulated arch anatomy without compromising tissue integrity Expanded oversizing window: A unique 6 33% oversizing window also allows physicians to choose the optimal radial force to fit patient anatomy and etiology

14 Thoracic stent graft designs Bare spring Partially uncovered stent Straight cut Bare spring is defined as a complete uncovered stent portion that has increased radial force and extends beyond the graft diameter. (e.g., MEDTRONIC VALIANT Stent Graft, MEDTRONIC TALENT Stent Graft) Partially uncovered stent is defined as the graft material pulled back over half the stent portion. Because the partially uncovered stent does not flare beyond the diameter of the covered stent, the radial force remains consistent throughout the device. (e.g., Conformable GORE TAG Thoracic Endoprosthesis) Straight cut is defined as the graft material completely covering the stent frame and no stent is exposed. (e.g., COOK ZENITH TX2 Stent Graft)

15 Partially uncovered stents Partially uncovered stents are designed to allow the maximum seal zone on the inner curve with no compromise to aortic blood flow or compromise to seal Conformable design helps achieve better graft contact in curved segment of the aorta minimizing the risk of Type I endoleak Covering an arch vessel with the partially uncovered stent may prevent blood flow to that vessel Graft achieves better contact due to conformable design.

16 Partially uncovered stents Partially uncovered stents are included in minimum 2 cm proximal landing zone due to enhanced conformability. Minimum coverage for 2 cm landing zone Labeled Proximal Diameter (mm) Partially Uncovered Stent Length (mm) Additional Covered Graft needed for Minimum 2 cm Landing Zone (mm)

17 Partially uncovered stents Designed for 360 aortic wall apposition in angulated anatomy reducing the need for proximal extensions. Partially uncovered stents help graft achieve better wall apposition* Straight cut design has less optimal graft wall apposition* * 25% oversizing in both models.

18 What is radial force? Radial force is the force exerted by the device (stent) when compressed to a smaller diameter than nominal (i.e., manufactured diameter) This is typically accomplished when the device is oversized (i.e., device is larger than vessel) Radial force is NOT constant through treatment range. Increased oversizing has larger associated radial force. This applies to all self-expanding stents. 24 mm vessel 20 mm vessel Lumen Struts Vessel wall < Less radial force with the same device in a smaller oversizing condition Lumen Struts Vessel wall 8.3% oversizing (e.g., 26 mm Conformable GORE TAG Thoracic Endoprosthesis in a 24 mm thoracic aorta) 30% oversizing (e.g., 26 mm Conformable GORE TAG Thoracic Endoprosthesis in a 20 mm thoracic aorta)

19 What is radial force? Radial force differs through treatment range. More oversizing has increased radial force. This applies to all self-expanding stents. Radial force Force vs. Oversizing More compression of stent Radial force Less compression of stent Oversizing

20 Consistent radial force Consistent radial force throughout the device is achieved along the entire length Competitive devices have increased radial force and point load due to flared orientation of bare springs Conformable GORE TAG Thoracic Endoprosthesis Competitive device

21 Expanded sizing to meet wide range of patient anatomies The Conformable GORE TAG Thoracic Endoprosthesis is the only thoracic endograft engineered to perform in 6 33% oversizing conditions Allows physicians to choose the optimal radial force to fit patient anatomy and etiology Tapered devices further expand treatment options with the Conformable GORE TAG Device Intended range of aortic diameters (mm) Intended range of aortic diameters (mm) mm 40 mm 45 mm Device diameters 26 x 21 mm 31 x 26 mm Device diameters 31 mm 34 mm 28 mm 26 mm 21 mm

22 Expanded sizing and oversizing windows Labeled Diameter (mm) Intended Aortic Diameter (mm) Device Length (cm) Device Profile (Fr) Same sizing chart for Type B dissections as for isolated lesions If there are two or three device options per IFU for a given aortic diameter, the physician can choose which device will be optimal for the patient s anatomy Oversizing Range (%) , , , 15, , 15, , 15, , 15, x / x / Partially Uncovered Stent Length (mm)

23 The only thoracic endograft engineered to perform in 6 33% oversizing conditions The mm range can be treated with as few as five sizes Conformable GORE TAG Device * The mm range can be treated with as few as five sizes. 20 Part numbers A unique 6 33% oversizing window also allows physicians to choose the optimal radial force to fit patient anatomy and etiology Device diameter (mm) VALIANT Device with CAPTIVIA Delivery System * Part numbers Complete inventory COOK ZENITH TX2 Device with PRO-FORM Delivery System * Part numbers BOLTON RELAY Plus Device and BOLTON RELAY NBS Device with PLUS Delivery System * BOLTON RELAY Plus Device Part numbers 82 BOLTON RELAY NBS Device with PLUS Delivery System * Part numbers Intended range of aortic diameters (mm) * Assumes rounding of measured vessel diameter (mm) to nearest whole number within IFU sizing range for aneurysm. Based on European IFU for each manufacturer.

24 Approved for Type B dissection

25 Clinical studies Gore s dissection clinical study history TAG Complex Pathology Study ADSORB (TAG 05-04) European Dissection Study TAG Conformable GORE TAG Device Dissection Study

26 TAG Complex Pathology Study This three arm study was designed to evaluate the use of the GORE TAG Device in the treatment of complex thoracic pathologies including ruptured thoracic aortic aneurysms, traumatic transections, and acute complicated Type B dissections 19 subjects enrolled in the dissection arm of this study Acute = diagnosis within 14 days of symptom onset Complicated = rupture, malperfusion, uncontrollable hypertension, uncontrollable pain, or impending rupture Primary endpoint Composite of death and total paraplegia in subjects at 30-days post-treatment compared with literature-based results from open surgical repair Outcomes Dissection arm resulted in half the combined mortality and paraplegia rates as compared to surgical controls in literature (16% vs. 32% respectively) Favorable aortic remodeling was observed with true lumen expansion, false lumen thrombosis, and reduction in overall aortic diameters

27 ADSORB (TAG 05-04) European Dissection Study Acute Dissection treatment with Stent graft OR Best medical therapy Randomized European study comparing endoluminal stent grafting and best medical therapy (BMT) to BMT alone in the treatment of acute uncomplicated Type B aortic dissections This study was evaluating the GORE TAG Device, not the Conformable GORE TAG Device 61 subjects enrolled in this study 30 stent graft and BMT 31 BMT alone Primary endpoint The incidence of one or more of the following events: Incomplete or no false lumen thrombosis at 1-year post randomization Aortic dilatation at 1-year post-randomization Aortic rupture (descending thoracic aorta or abdominal aorta) through the 1-year follow-up visit

28 ADSORB (TAG 05-04) European Dissection Study Outcomes The 1-year primary endpoint favored the stent graft plus BMT over the BMT alone group ADSORB results confirmed the findings of the INSTEAD trial that endovascular treatment of Type B dissection results in expansion of the true lumen and a reduction in the false lumen. The ADSORB study has demonstrated that this can be performed effectively in the acute phase of dissection.

29 TAG Conformable GORE TAG Device Dissection Study This single arm study was designed to evaluate the use of the Conformable GORE TAG Device in the treatment of acute complicated Type B dissections 50 subjects enrolled in this study Acute = diagnosis within 14 days of symptom onset Complicated = rupture and / or malperfusion only Primary endpoint All-cause mortality incidence through 30-days post-treatment as compared to an established performance goal Performance goal based on literature (including TAG data) and SVS compiled data from physician sponsored IDE studies Outcomes The 30 day all-cause mortality rate was acceptable (met the performance goal) Favorable aortic remodeling was observed with true lumen expansion, false lumen thrombosis, and reduction in false lumen diameters

30 Treatment considerations Access Access vessels may be dissected, so consider non dissected side for access if appropriate Ensure vessels are of appropriate size for sheath advancement; access vessels in dissection patients may be more prone to damage Atraumatic wires / catheters should be used when traversing the aorta. Wires and catheters can cause retrograde dissections upon advancement, so extreme caution is needed. Ensure guidewire is only in true lumen and does not pass from the true to false lumen through septal tears; angiography and / or IVUS may aid in this determination

31 Treatment considerations Deployment Acute Type B dissections If two devices are required, deploy proximal device first Distal deployment first could cause inadvertent pressurization of the false lumen and may result in retrograde Type A dissection Pre-treatment angiogram; no dissection visible in the ascending aorta Distal device deployed first and proximal device being positioned; Type A dissection visible in the ascending aorta Final angiogram shows Type A dissection

32 Treatment considerations Ballooning Care should be taken when ballooning in patients with a history of aortic dissection Ballooning should only be completed when necessary such as treatment of an endoleak Over inflation of the balloon in dissection patients could lead to aortic damage including retrograde dissection and damage to the septum When ballooning in dissection patients, balloon the proximal landing zone first and then overlapped areas (if appropriate). Do not balloon the distal neck of dissections. Inadvertent pressurization of the false lumen may result in retrograde dissection or damage to the septum. Ballooning native vessel could lead to vessel damage, rupture, or death

33 Endoleaks definitions for dissections Type Ia endoleak Type Ib endoleak No endoleak

34 Endoleaks definitions for dissections Type II endoleak Type II endoleak Type III endoleak

35 Features and benefits

36 Conformable GORE TAG Device is conformability without compromise Fully supported graft material for low spring-back force Radial fit for customized oversizing based on patient anatomy Proximal partially uncovered stents for wall apposition in highly angulated anatomy Fully covered distal end for decreased risk of septum perforation

37 Conformable GORE TAG Device is conformability without compromise Proven compression resistance No reports of compression with more than 110,000 devices distributed worldwide* Increased wire diameter optimizes radial force to resist compression in high flow aortas Nine apex stent pattern further distributes point load and contributes to long-term durability in maximum oversizing conditions Unique sutureless design and stent graft construction facilitates consistent conformability throughout the device for uniform arch support Flexible delivery system tracks in challenging anatomy Soft leading catheter tip for navigation through tortuous anatomy Easy one-step deployment * W. L. Gore & Associates, Inc. GORE TAG Thoracic Endoprosthesis Annual Clinical Update. Flagstaff, AZ: W. L. Gore & Associates, Inc; AS0089-EN3.

38 Conformable GORE TAG Device is conformability without compromise Able to treat more patients Small diameter and tapered devices offer a large treatment range A unique 6 33% oversizing window also allows physicians to choose the optimal radial force to fit patient anatomy and etiology Larger device oversizing windows engineered, tested, and proven to accommodate differences in proximal and distal landing zone diameters Leverages more than 40 years of experience with eptfe and a reliable platform with proven clinical durability and strength Low permeability with abrasion-resistant properties Optimizes graft and film layers to maximize durability and conformability Reinforcing film Low permeability film eptfe graft

39 Time-tested success For more than 20 years, the GORE TAG Device family has demonstrated impressive success in both clinical studies and real-world commercial use. More than 125,000 devices distributed worldwide For more than two decades, we have worked alongside physicians in the evolution of the GORE TAG Device family. Our collaboration has resulted in the distribution of more than 125,000 devices, for the treatment of more than 73,500 patients worldwide.* Proven clinical results The GORE TAG Device family is supported by more than 20 years of clinical experience. Most studied thoracic endograft available With the first clinical implant occurring in 1998, the GORE TAG Device family has been studied in ten FDA approved clinical studies, one European clinical trial (ADSORB), and one worldwide registry (GREAT). Forty years of experience with eptfe graft material Having pioneered eptfe graft technology more than 40 years ago, we continue to collaborate with physicians and scientists to create a robust and reliable design platform based on proven clinical performance. * Data on file

40 Required ancillary devices

41 GORE Tri-Lobe Balloon Catheter Unique design allows continuous blood flow around the lobes while inflated 1 Decreased hemodynamic pressure on the inflated balloons with approximately 80% of flow for distal perfusion 2 Minimizes potential for endoprosthesis movement and blood pressure spikes post deployment due to significantly reduced hemodynamic pressures 1 Rapid, uniform, and simultaneous inflation and deflation 3 Inflation diameters of mm Two sizes: Small (16 34 mm aortic diameter) Large (26 42 mm aortic diameter) 1. Gendron M. Simulated Use Testing of Aortic Balloon Catheter for Design Verification Final Amendment. Flagstaff, AZ: W. L. Gore & Associates, Inc; [Work plan]. MD Bloss R, Krall B. Balloon Testing on Pulse Duplicator. Flagstaff, AZ: W. L. Gore & Associates, Inc; [Technology notebook] Nilson T. Balloon Testing of Aortic Balloon Catheter (ABC) for Design Verification (DV). Flagstaff, AZ: W. L. Gore & Associates, Inc; [Work plan]. MD40026.

42 GORE Tri-Lobe Balloon Catheter Recommended inflation volume based on aortic diameter Intended balloon diameter (mm) Inner vessel diameter (mm) Recommended inflation volume (cc) BCM BCL Recommended Inflation volume (cc) BCM1634 BCL Intended balloon diameter (mm) Inner vessel diameter (mm)

43 GORE DrySeal Flex Introducer Sheath Distinct combination of enhanced flexibility and kink resistance Optimized profile with decreased sheath wall thickness for larger inner diameter and decreased outer diameter Smooth guidewire to dilator transition Locking dilator for ease of insertion Excellent sheath lubricity Catalogue Number Sheath Size (Fr) Length (cm) Minimum Sheath ID (mm) Nominal Body OD (mm) Sheath Effective Length (cm) Sheath Working Length (cm) Assembly Length (cm) DSF DSF DSF DSF DSF DSF DSF DSF DSF Dilator Length (cm)

44 Summary

45 Summary Conformable GORE TAG Device is the first thoracic stent graft approved in the U.S. to treat aneurysms, transections, and Type B dissections Engineered to maintain performance and durability of the GORE TAG Device Each device diameter is engineered for the expected anatomic and physiologic environment associated with a given treatment range Expanded sizes to treat a wide range of thoracic aortas between mm Engineered to be conformable and compression resistant in 6 33% oversizing conditions Physician can select oversizing based on patient anatomy for optimal conformability and customized radial fit Off-the-shelf tapered designs provide physicians with more options to match the endograft to the individual patient anatomy

46 Pioneering TEVAR therapy FIRST thoracic stent graft to receive CE Mark in Europe FIRST thoracic stent graft approved in U.S. FIRST thoracic stent graft approved in Japan 2012 FIRST thoracic stent graft approved in U.S. for isolated lesions including traumatic transections* 2013 FIRST thoracic stent graft approved in U.S. for aneurysms, transections, and acute and chronic Type B dissections 2016 FIRST TEVAR device to reach 100,000 devices distributed worldwide * Conformable GORE TAG Device was approved in U.S. for DTA aneurysms in 2011.

47 INDICATIONS FOR USE IN THE US: The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta, including: Isolated lesions in patients who have appropriate anatomy, including: adequate iliac / femoral access, aortic inner diameter in the range of mm, 20 mm non-aneurysmal aorta proximal and distal to the lesion; Type B dissections in patients who have appropriate anatomy, including: adequate iliac / femoral access, 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected, diameter at proximal extent of proximal landing zone in the range of mm. CONTRAINDICATIONS: Patients with known sensitivities or allergies to the device materials; patients who have a condition that threatens to infect the graft. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions, and adverse events. INDICATIONS FOR USE UNDER CE MARK: The GORE TAG Thoracic Endoprosthesis is indicated for endovascular repair of the descending thoracic aorta. CONTRAINDICATIONS: Patients with known sensitivities or allergies to the device materials; patients with a systemic infection who may be at increased risk of endovascular graft infection. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions, and adverse events. Products listed may not be available in all markets. BOLTON, RELAY NBS, and RELAY PLUS, are trademarks of Bolton Medical. COOK, PRO-FORM, TX2, and ZENITH are trademarks of Cook Medical, Inc. CAPTIVIA, TALENT, and VALIANT are trademarks of Medtronic, Inc. GORE, TAG, and designs are trademarks of W. L. Gore & Associates. 2014, 2018 W. L. Gore & Associates, Inc. AS1354-EN3 APRIL 2018 W. L. Gore & Associates, Inc. Flagstaff, AZ (Asia Pacific) (Europe) (United States) (United States) goremedical.com