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Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update TABLE OF CONTENTS Section

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update ABSTRACT This 2015 Clinical Update report provides a current summary of long-term clinical experience for the Endologix studies for endovascular abdominal aortic aneurysm (AAA) repair with the Endologix Powerlink and AFX stent graft systems. Five US clinical studies involving 726 patients have been performed and results submitted to the US FDA to support marketing approvals. This includes the Infrarenal Bifurcated study, Suprarenal Bifurcated study, XL Aortic Extension study, Suprarenal Aortic Extension study,...

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update READER’S GUIDE Endologix, Inc. has prepared this clinical update to provide current information on the worldwide experience to date to physician users. Data and information on the final follow-up on the test patients implanted with the device during the original studies and on surgical control patients is detailed, including patient accountability, adverse events, incidence of endoleak, and aneurysm sac diameter regression. In addition, worldwide post-market information pertaining to product use, safety, and...

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update The Endologix unibody infrarenal bifurcated stent grafts (primary device) has a main body with two attached limbs. Accessory stent grafts for customization to the patient anatomy are comprised of infrarenal and suprarenal proximal extensions and limb extensions in straight, tapered, flared, and stepped configurations. Both Powerlink and AFX stent grafts are constructed from the same cobalt chromium alloy stent cage. The high density expanded polytetrafluoroethylene (ePTFE) graft cover used in the AFX stent graft...

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update The AFX® Endograft AAA System is used with a separate 17Fr AFX Introducer System (19Fr outside diameter). All AFX stent graft delivery systems are compatible with the AFX Introducer System. There are three types of stent graft delivery systems that require delivery through the introducer system: the bifurcated stent graft delivery system; the Vela™ Proximal Endograft System, and the standard limb extension delivery system. A lower profile limb extension delivery system in 14 or 16Fr outer profile may be used...

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update decreased in the majority of patients, and mean sac diameter continued to decrease over time. Secondary interventions within five years were performed primarily for Type II endoleak, with low rates of device-related interventions for endoleak or limb occlusion. No aneurysm rupture, stent fracture, graft failure, or other significant device integrity loss was observed through final five-year follow-up. No aneurysm-related deaths were observed in the PEVAR trial among 100 patients randomized to either totally...

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update SECTION 1: US Pivotal Clinical Trials Endologix has completed five US pivotal clinical studies of the Powerlink System for endovascular AAA repair that were the basis for determinations of reasonable assurances of safety and effectiveness by the US Food and Drug Administration:† • Infrarenal Bifurcated Study: This multicenter, prospective, concurrently controlled clinical study compared 192 standard risk patients with anatomy suitable for endovascular repair to 66 patients treated with open surgery. Patients...

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update Suprarenal Aortic Extension Study: This multicenter, prospective, single arm clinical study enrolled 44 patients with infrarenal aortic necks up to 26mm in diameter and anatomy suitable for endovascular repair. Enrollment commenced in May 2006, and per the originally approved protocol and patient consent, patients were followed to the primary 30-day time point with continued long-term follow-up commitment. An independent DSMB periodically reviewed the results of this study and recommended study continuation...

Table 1. Patient and Imaging Accountability - Infrarenal Bifurcated Study Test Group1

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update Table 3. Patient and Imaging Accountability – Suprarenal Bifurcated Study Test Group1 Events >4Yrs and <5Yrs 5 Years (±3 months) Events >3Yrs and <4Yrs 4 Years (±3 months) Events >2Yrs and <3Yrs 3 Years (±3 months) Events >1Yr and <2Yrs 2 Years (±3 months) Events >6Mo and <1Yr 1 Year (±2 months) Withdrawn/ Lost Events >1Mo and <6Mo 6 Months (±1 month) Events after Implant and <1Mo 1 Month (±2 weeks) Technical Failure Conversion Aneurysm Size Change Pts. with Adequate Imaging to Events Occurring Before Assess...

Patient Follow-up n (% of eligible) Pts. with Imaging n (% of eligible) Pts. with Adequate Imaging to Assess Parameter: n (% of eligible) Events Occurring Before Next Visit Events after Implant and <1Mo

Table 5. Patient and Imaging Accountability - Suprarenal Aortic Extension Study1

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update Aneurysm-Related Mortality Aneurysm-related mortality is defined as any death within 30 days of implantation, regardless of cause; and any death after 30 days due to aneurysm rupture, a primary or secondary procedure, or surgical conversion. Table 7 summarizes the aneurysm-related deaths in the Infrarenal Bifurcated Test, Surgical Control, Suprarenal Bifurcated Test, XL Study, Suprarenal Aortic Extension, and PEVAR Trial groups. Table 7. Aneurysm-Related Death Summaries By Study Group