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 or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Other Financial Benefit Company Cook, Cordis, Gore, Endologix, Bolton, Silkroad, Trivascular, Medtronic, Spectranetics, Bard Spectranetics, Biomet, Endologix, TVA Medical VIVA Physicians Board Member
Ovation Platform 14F OD ultra-low profile system enables smooth aneurysm access Low permeability PTFE enables effective aneurysm exclusion and device patency Staged deployment of suprarenal stent allows simple, precise placement Polymer-filled sealing ring creates a custom seal and protects the aortic neck Conformable, kink resistant PTFE iliac limbs designed to reduce risk of occlusion
Ovation Custom Seals to Each Patient Anatomy Reverse Taper Neck Pre-Op 4 Year Follow-Up Chronic outward force from oversized stent, combined with blood pressure, can result in neck dilatation and may compromise seal. Sealing ring creates no chronic outward force and insulates the neck from blood pressure, resulting in a stable neck diameter. No Type 1 Endoleak Stable Neck Diameter
Ovation Well Suited for Challenging Distal Anatomy Lowest profile of any FDA approved EVAR device Highly flexible limbs and delivery system PTFE iliac limbs with helical architecture for exceptional flexibility and minimal luminal encroachment
Ovation Well Suited for Challenging Distal Anatomy Tight Access Vessels Tortuous Iliacs Narrow Distal Aorta 5.3 mm 3.2 mm 13mm Pre-Op 5 Year Courtesy Thomas Nolte, MD, Bad Bevenson, Germany Pre-Op 4 Year Courtesy Francisco Valdes, MD, Santiago, Chile Pre-Op 5 Year Courtesy Manish Mehta, MD, Saratoga Springs, NY
Robust Clinical Evidence Validates Ovation Platform Expands EVAR access to more patients and improves EVAR outcomes for all patients Over 10,000 patients worldwide have been treated with Ovation Abdominal Stent Graft platform, with over 1,000 patients in a controlled or real-world study 161 patients 501 patients 250 patients 225 patients 75 patients Ovation Global Pivotal IDE Ovation EU Post Market Registry 36 Centers US, Chile, Germany 5 Year Results 30 Centers 3 Year Results FAST Track EVAR 40 Centers 30d Results 2:1 Male/Female 45 Centers Enrolling Ovation Alto IDE Begins in 2017
Ovation Global Pivotal Anatomical Demographics 161 patients enrolled in Chile, Germany and USA from Nov 2009 Dec 2011 ~40% of patients had complex AAA anatomies Minimum Access Vessel <6mm, 25% Baseline Aortoiliac Characteristics Mean ± SD Min, Max Aortic diameter 13mm below renal artery (mm) 1 22.7 ± 3.1 16.6, 32.3 Juxtarenal angle (degrees) 1 19.1 ± 13.5 0.0, 60.0 Proximal neck length (mm) 2 22.9 ± 12.5 1.0, 50.0 Aortic aneurysm diameter (mm) 2 53.6 ± 9.0 37.8, 90.0 Aortic bifurcation diameter (mm) 2 20.3 ± 6.9 11.5, 53.5 Left iliac minimum access diameter (mm) 2 7.0 ± 1.6 3.2, 11.5 Right iliac minimum access diameter (mm) 2 7.0 ± 1.6 3.5, 11.4 1 Data provided by site imaging 2 Data provided by imaging core lab Neither Criteria, 59% Neck Length <10mm, 8% Both Criteria, 8% (66/161) of Ovation Trial patients treated had access vessels <6mm, aortic neck length <10mm, or both.
Safety and Effectiveness 5 year results of the global pivotal clinical study to evaluate the safety and effectiveness of the Ovation Abdominal Stent Graft System. Technical Success 1 Safety 2 0 to 30 days N=161 31 to 365 days N=159 366 to 730 days N=154 731 to 1095 days N=140 1096 to 1460 days N=124 All N=161 Successful delivery and deployment of one aortic body and two iliac limbs 100% 1461 to 1825 days N=105 MAEs 2.5% 3.8% -- -- -- -- Device Related MAE 0% 0% -- -- -- -- Rupture 0% 0% 0% 0% 0% 1% Conversion 0% 0% 0% 0% 0% 0% Effectiveness 3 30 Day 1 Year 2 Years 3 Years 4 Years 5 Years Data extraction: August 2, 2016 1 Site reported 2 MAE and Device Related MAE from CEC-adjudicated data. Rupture and Conversion site reported. 3 Endoleaks and Migration Core Lab reported; Occlusion site reported. Type I/III Endoleak 0% (0/153) 0% (0/143) 0% (0/120) 0% (0/109) 0% (0/87) 0% (0/66) Migration Baseline 0% (0/150) 0% (0/133) 0% (0/117) 0% (0/96) 0% (0/78) Occlusion 0% (0/159) 0% (0/151) 0.7% (1/135) 0% (0/120) 2% (2/98) 2.5% (2/79)
Freedom from Mortality through 5 Years 98% AAA-Related 75% All Cause
Type 1a Endoleak Intervention Intra-Operative Type 1a Endoleak and Adjunctive Device (Palmaz) 3.1% (5/161) 96.6% Five Year Freedom from Reintervention for Type 1 Endoleak Freedom from Secondary Intervention for Type 1 Endoleak 96.6% at 5 Years
Freedom from AAA-Related Reintervention US 84.2% at 5 Yrs GLOBAL 81.2% at 5 Yrs Very important as we continue to transition to value and population management over a lifetime
SELF EXPANDING STENT GRAFT Chronic outward force from stent, combined with blood pressure, can result in aortic neck dilatation. 1 Proximal Neck Dilatation after EVAR: Does Stent Design Matter? 24.6% Neck Dilation over a 15 month to 9 year period Increased size of aorta 26% incidence of clinical events with dilation Type 1a endoleak, migration, and reintervention vs 2% Without dilation
Proximal Neck diameter average expansion (mm) Proximal Neck Dilatation after EVAR: Does Stent Design Matter? Core lab results demonstrate stable neck diameter and durable seal with Ovation through 5 years 6.0 5.0 4.0 3.0 Aortic Neck Dilatation Over Time 4.7 3.6 2.4 5.3 Self- Expanding Stents 1 1 Monahan JVS 2010: 52: 303-7. N=46. Devices: Cook Zenith 2 Rodway EJVES 2008;35:685-93 EVAR: N=67, Open N=56. Data to 2 years. 3 Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of Aug 2, 2016 4 Neck dilation = growth > 3mm at 10mm, 13mm, and 15mm below renals 2.0 1.0 0.0-1.0 0.0 0.4-0.2 0.8 0.0 Open Repair 2 0.2 0.2 Ovation System 3,4 Baseline 1 Year Growth 2 Year Growth 3 Year Growth 4 Year Growth 5 Year Growth 0.1
Women and AAA: An Underserved Population More women than men are ineligible for EVAR Inadequate neck length Narrow access vessels Women are under represented 21% of AAAs in the US are in women, yet only 6-15% patients enrolled in EVAR IDEs are female Outcomes in women are worse
EVAR Outcomes and Treatment: Women vs. Men 6.0% 5.0% % In-Hospital EVAR Deaths Male Female 4.0% 3.0% 2.0% 1.0% 0.0% 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 http://www.hcup-us.ahrq.gov/ Procedure Code 39.71 Endo Impl Grft Abd Aorta
The LUCY Study First prospective study of EVAR in Females Jennifer Ash, MD, Principal Investigator Christie Clinic, Champaign, IL 225 patients 75 females (treatment arm) 150 males (control arm) Primary endpoint: MAEs at 30 days 30 day and 1 year follow-up Data to be presented at SVS 2017
Least Invasive Fast-Track (LIFE) EVAR Registry Demonstrate the clinical and cost benefits associated with the ultralow profile (14F) Ovation Abdominal Stent Graft platform under the least invasive conditions defined in the Fast-Track EVAR protocol: Percutaneous Access No General Anesthesia No ICU Admission Next-day Discharge
No Device- or Procedure-Related Major Adverse Events As of August 2, 2016 1 MAE non-device nor procedure-related: death due to acute respiratory failure 28 days post procedure
30 Day Hospital Readmissions Most common EVAR readmission drivers are MI, renal, respiratory and wound complications Median EVAR readmission cost $17,700 (if for graft occlusion) to $23,600 (if for endoleak) Cost drivers are due to additional surgeries, ICU services, and length of stay LIFE readmission rate is 5x less than contemporary EVAR reports EVAR ACS NSQIP Gupta 2014 EVAR ACS NSQIP Chen 2016 LIFE Registry EVAR Cases (N) 2369 3886 250 Time Period 2011 2012-2013 2015-2016 Unplanned 30d Readmission 7.9% 8.1% 1.6% Operation during Readmission 28% - 0% ACS NSQIP: American College of Surgeons National Surgical Quality Improvement Program Chen SL et al. Perioperative Risk Factors for Readmission Following EVAR. Presented at SCVS, 2016. Gupta PK, et al. Unplanned readmissions after vascular surgery. J Vasc Surg 2014;59:473-82. MM1564 Rev 01
Next Generation Ovation platform will help physicians to broaden patient applicability More intuitive design for increased confidence in Ovation
Elevated Sealing Ring ~ 7 mm IR Ultra-low profile for small access and tortuous anatomy 1 4 2 3 Webbing at bifurcation to facilitate cannulation Offset aortic body legs for improved visualization
Ovation Alto Case
EXPANDING PATIENT APPLICABILITY WITH POLYMER SEALING OVATION ALTO STENT GRAFT IDE STUDY 75 patients /12 US Centers Enrollment to begin Q1 2017
Conclusions Ovation platform addresses a broad patient population across straightforward and complex anatomies Over 10,000 patients worldwide have been treated with Ovation Abdominal Stent Graft platform Robust short- and long-term clinical evidence through 5 years validates Ovation Platform Excellent safety and durability Economic utility Next generation--ovation Alto further expands endovascular options for AAA patients ELEVATE IDE in 2017