14.54 krajcer global experience with tri vascular

Texas Heart Institute™

Zvonimir Krajcer, MDDirector, Peripheral InterventionSt. Luke’s Episcopal Hospital,

Texas Heart Institute

Global Experience With TriVascular Ovation Abdominal Stent Graft System


• On the speaker’s bureau for W.L. Gore, Endologix, Medtronic, Volcano, Abbott Vascular, TriVascular, Lombard

• Training courses for: W.L. Gore, Endologix, Medtronic, Volcano, BARD, Lombard, TriVascular

Disclosures


Short Aortic Necks (<15mm)

Reverse Tapered Necks

Calcium Thrombus Severe Angulation Large Diameter Calcium/Thrombus lined

Necks

Reverse Tapered NecksAt Inferior

Renal Artery

At IR + 5

At IR + 13

48% Patients < 15mm Necks*M2S Database – 43,000 CT Scans

* Derived from M2S Measurement Database of 43,000 AAA CT Scans

63% Women < 15mm Necks**(CHAP) Collaborative effort – 1,063 CT Scans

** New England Society for Vascular Surgery, Matthew P. Sweet, MD et all The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repairClinician-FDA Collaborative effort, Characterization of Human Aortic Anatomy Project (CHAP), 1063 CT Scans

Persistent EVAR ChallengesHostile Neck Anatomy


Narrow Access Vessels

Access Vessel Tortuosity

Narrow (<6mm) Occluded Torturous Calcified Aneurysmal

40% Patients < 6mm*M2S Database – 43,000 CT Scans

* Derived from M2S Measurement Database of 43,000 AAA CT Scans

3.2 mm 5.3 mm

55% Female Patients <6mm **(CHAP) Collaborative effort – 1,063 CT Scans

** New England Society for Vascular Surgery, Matthew P. Sweet, MD et all The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair Clinician-FDA Collaborative effort, Characterization of Human Aortic Anatomy Project (CHAP), 1063 CT Scans

Persistent EVAR ChallengesHostile Access Anatomy


Hostile Neck Adjunctive procedures

Intra-op endoleaks

All cause mortality

On label 9.9% 0.5% 1.1%2 hostile neck parameters 26.7% 6.7% 13.3%

>2 hostile neck parameters 50% 16.7% 16.7%

Speziale et al. shows greater proximal seal complication risks as the number of hostile neck parameters increases

Speziale F et al, Annals of Vascular Surgery (2014), doi: 10.1016/j.avsg.2014.06.057.

Greater than 1 hostile neck parameter significantly increases mortality, major adverse events, intra-op endoleaks and adjunctive procedures

Influence of Multiple Hostile Neck Parameters


At 14F, the ultra-low profile system enables smooth access to the aneurysm

Staged deployment of suprarenal stent allows simple, precise placement

Inflatable & conformablePolymer-filled sealing ring creates a custom seal and protects the aortic neck

Low permeability PTFE enables effective aneurysm exclusion and device patency

Conformable, kink resistant PTFE iliac limbs designed to reduce risk of occlusion

Ovation Prime® System

Water tight seal in ring (IR+13)

• IFU neck length > 7mm • Diameter, not length, is

key to pt. selection • Seal achieved if diameter

is 15.5-30.4 mm at IR+13.


Investigator SiteBotti, Charles Riverside Methodist HospitalCheema, Mohiuddin Hartford HospitalClair, Daniel Cleveland Clinic Eidt, John Central Arkansas VAEskandari, Mark Northwestern MemorialGlickman, Mark Sentara Medical GroupGray, Bruce Greenville HospitalHaser, Paul UMDNJHassoun, Heitham Methodist HospitalHenretta, John Mission HospitalHodgson, Kim Southern Illinois UniversityJain, Ash Washington HospitalJicha, Douglas Santa Rosa MemorialJones, Paul Mercy Medical CenterJordan, William UABKasirajan, Karthik Emory UniversityKrajcer, Zvonimir St. Luke’s HospitalLaird, John UC DavisMaini, Brijeshwar Moffitt Heart and VascularMakaroun, Michel UPMCMaldonado, Thomas NYU HospitalMehta, Manish Albany Medical CenterMishkel, Gregory Prairie Heart Moore, Wesley UCLAMotew, Stephen Forsyth Medical CenterMurkherjee, Dipankar Inova Fairfax HospitalRizvi, Adnan Minneapolis Heart InstituteSternberg, Charles Ochsner Health System

Investigator SiteBrunkwall, Jan Uni. Klinik KolnKrankenberg, Hans Medizinisches Versorgungszentrum,

HHMathias, Klaus Klinikum DortmundNolte, Thomas Herz und Gefaßzentrum, Bad

BevensenScheinert, Dierk Park Krankenhaus, LeipzigSievert, Horst CVC, FrankfurtTorsello, Giovanni St. Franziskus-Hospital, Münster

Investigator SiteValdes, Francisco Catholic University

161 patients enrolled in Chile, Germany & USA• First Global IDE Trial

Ovation® Global Pivotal Trial


Safety2 0 to 30 DaysN=161

31 to 365 Days

N=159

366 to 730 Days

N=154

731 to 1095 Days

N=138Major Adverse Events 2.5% 3.8% -- --Device Related Major Adverse Events 0% 0% -- --

Rupture 0% 0% 0% 0%Conversion to Open Repair 0% 0% 0% 0%Limb Occlusions3 0.6% 0.6% 0% 0.7%

Effectiveness4 30 Day 1 Year 2 Years 3 YearsType I and III Endoleaks 0% (0/153) 0% (0/143) 0% (0/121) 0% (0/106)Migration Baseline 0% (0/150) 0% (0/133) 0% (0/113)

Technical Success1 N=161 Defined as successful, delivery and deployment of one aortic body and two iliac limbs 100%

Data as of July 25, 20141Technical Success based on investigator reports2 Major Adverse Events and Device Related Major Adverse Events based on Clinical Events Committee (CEC) adjudicated data. Rupture and Conversion to Open Repair based on investigator reports3Limb Occlusions defined as re-interventions due to limb occlusion4 Endoleaks and Migration rates based on Core Lab Data (M2S)

Ovation Global Pivotal Trial 3 Year Results


Hostile Neck Features/Patient # of Patients (%)0 105 (65.2)1 31 (19.3)2 22 (13.7)3 3 (1.9)

1Based on Core Lab Data (M2S),

Hostile Neck Features # of Patients (%)Neck Angle > 60° 6 (3.7)Neck Length < 10mm 26 (16.1)Diameter > 28mm 9 (5.6)Calcium ≥ 50% 0 (0)Thrombus ≥ 50% 1 (0.6)Reverse Taper 42 (26.1)

Ovation Global Pivotal TrialHostile Neck Features1


40% (66/161) of patients treated had access vessels <6mm, aortic neck length <10mm, or both.

1Major Adverse Events and Device Related Major Adverse Events based on Clinical Events Committee (CEC) adjudicated data. 2Limb Occlusions defined as re-interventions due to limb occlusion3 Endoleaks and Migration rates based on Core Lab Data (M2S)

Safety10-30 DaysN=66

31-365 DaysN=66

366-730 DaysN=63

731-1095 DaysN=53

Major Adverse Events 0% 3.0% -- --Device Related MAEs 0% 0% -- --Rupture 0% 0% 0% 0%Conversion to Open Repair 0% 0% 0% 0%

Limb Occlusions2 1.5% 0% 0% 0%

Effectiveness3a 30 Days 1 Year 2 Years 3 Years

Type I and III Endoleaks 0% (0/64) 0% (0/59) 0% (0/48) 0% (0/36)

Migration Baseline 0% (0/62) 0% (0/54) 0% (0/41)

Ovation Global Pivotal TrialChallenging Subgroup Analysis


GA

Percutaneous43%

Access Type

Cut-Down Percutaneous

Major Adverse Event @ 30 Days 3.3% (3/92) 1.4% (1/69)

Treatment Success @ 1-year 98.9% (91/92) 100% (69/69)

Anesthesia Time (mean) 191 minutes 149 minutes

Procedure Time (mean) 118 minutes 98 minutes

Hospitalization (median) 2 days 1 day

Subjects undergoing percutaneous access achieved similar clinical outcomes with slightly lower time spent related to anesthesia, procedure and hospitalization time.

Low Profile Device Well Suited for Percutaneous Access


• Multicenter, prospective, post-market study• 501 patients enrolled @ 30 sites across Europe• Enrolled May 2011 – December 2013• Safety and Performance Endpoints assessed by Investigator at

1-month, 6-month, and annually to 5 years• Study Completion: 2019• Primary Endpoints

Technical success Freedom from Type I and III endoleaks, aneurysm rupture,

expansion, conversion, occlusion, and migration• CEC adjudication of device related adverse events

OVATION Post-Market Registry


*Data as of January 6, 2015 based on investigator reported data.1Limb Occlusions defined as re-interventions due to limb occlusion2Ns represent the number of completed follow-up visits for 1m, 6m, 1yr, and 2yr3Multiple imaging modalities were used during follow up

A multicenter, prospective, European post-market registry to evaluate the safety and performance of the TriVascular Ovation® / Ovation Prime® Systems

Performance2 30 Day 1 Year 2 Years

Type I and III Endoleaks 1.1% (5/454) 1.6% (6/384) 0.5% (1/196)Migration 0% (0/440) 0.3% (1/378) 0% (0/195)

Technical SuccessAll

N=501Successful, delivery and deployment of one aortic body and two iliac limbs 99.6%

Safety0 to 30 Days

N=50131 to 365 Days

N=499366 to 730 Days

N=472Rupture 0.2% 0% 0%Conversion to Open Repair 0% 0.2% 0.4%Iliac Occlusion1 1.2% 1.2% 0%

OVATION Post-Market Registry2 Year Results


• Over 6500 patients worldwide have been treated with Ovation and Ovation Prime Abdominal Stent Graft Systems, with over 700 subjects in a tightly controlled study or registry 161 patients enrolled in the Ovation Global Pivotal Trial 77 patients enrolled in the Ovation Continued Access Trial Over 80 patients enrolling in US Post-Approval Study 501 patients enrolled in the OVATION Post Market Registry Additional 400+ subjects enrolling in current post market

registries

• Patient demographics, anatomical characteristics, and procedural characteristics indicate a challenging patient cohort

• These data provide compelling evidence that the Ovation system offers significant advantages and safely expands EVAR.

Conclusion

14.54 krajcer global experience with tri vascular

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