LINC 2015 |

Real World Experience The Ovation Prime® Stent

Graft System

Marc Bosiers Koen Deloose Joren Callaert

A.Z. Sint-Blasius, Dendermonde

Imelda Hospital, Bonheiden

Patrick Peeters Jürgen Verbist

W. Van den Eynde

OLV Hospital, Aalst

Lieven Maene Roel Beelen

R.Z. Heilig Hart, Tienen

Koen Keirse Bart Joos

Patrick Peeters, MD Chief. Dept. of Surgery

Chief. Dept Cardio-Vascular & Thoracic Surgery Imelda Hospital Bonheiden (Belgium)

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LINC 2015 |

Disclosure

Speaker name: Patrick Peeters, MD

I have the following potential conflicts of interest to report:

Consulting - TriVascular

Employment in industry

Shareholder in a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

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LINC 2015 |

History

First implementation in patients in 1991

->Dr. Juan Parodi : custom-made Dacron tube

Endovascular repair for AAA has gained acceptance and availability

Development of new commercial available devices

Evolution : 1st generation device until 4th generation

4th generation device :

Ovation (Trivascular), Exluder (GORE), Zenith Flex (Cook),

INCRAFT (Cordis)

LINC 2015 |

Features of a good endoprothesis

Treating the infrarenal aneurysm even juxtarenal AAA

• Freedom from type I or III endoleaks

• Freedom from aneurysm expansion

• Freedom from aneurysm rupture

• Need for adequate sealing, fixation

• Need for flexible device for tortuous lesions

• Need for small French size, percutaneous use

LINC 2015 |

At 14F, the ultra-low

profile system enables

smooth access to the

aneurysm

Ovation Prime®

Abdominal Stent Graft

Staged deployment of

suprarenal stent allows

simple, precise placement

Polymer-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

iliac limbs designed to reduce

risk of occlusion

LINC 2015 |

Ovation Post Market Registry

• 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

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LINC 2015 |

OVATION Post-Market Registry 2-Year Results

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% (0/440) 0.3% (1/378) 0.0% (0/195)

*Data as of January 6, 2015 based on investigator reported data.

1Limb Occlusions defined as re-interventions due to limb occlusion

2Ns represent the number of completed follow-up visits for 1m, 6m, 1yr, and 2yr

Technical Success All

Successful, delivery and deployment of one aortic body and two iliac limbs

99.6% (499/501)

Safety 0 to 30 Days 31 to 365 Days 366 to 730 Days

Rupture 0.2% (1/501) 0.0% (0/499) 0.0% (0/472)

Conversion to Open Repair 0.0% (0/501) 0.2% (1/499) 0.4% (2/472)

Iliac Occlusion1 1.2% (6/501) 1.2% (6/499) 0.0% (0/472)

©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 7

LINC 2015 |

European Post-Market Registries

• Registries have enrolled over 2400 patients – TriVascular OVATION, Medtronic ENGAGE, Gore GREAT, Endologix EVAS

FORWARD

• Purpose of Registries: – To prospectively evaluate global real world safety and clinical

performance data

• Study Designs: – Real-world patients: Inclusion/Exclusion criteria per IFU

8 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or

on the order of a physician.

LINC 2015 |

European Post-Market Registries Device Indications / Features*

TriVascular OVATION

Medtronic ENGAGE

Gore GREAT

Endologix EVAS FORWARD

Key Indications

Proximal Neck Length ≥ 7mm ≥ 10mm ≥ 15mm ≥ 10mm

Proximal Neck Angle (Degrees)

<60 if neck length ≥ 10 mm

≤ 45 if neck length < 10 mm

< 60 < 60 < 60

Neck Diameter 16-30mm Inner Wall

19-32mm Inner Wall

19-32mm Inner Wall

16-32mm Inner Wall

Iliac Diameter 8-20mm 8-25mm 8-25mm 8-35mm

Device Features

Profile OD (main body)

14F-15F 18F-20F 20F 17F

Sheath Required No No Yes No

*Device Indications from Company Instructions for Use

©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or

on the order of a physician.

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LINC 2015 |

1Results as of January 6, 2015 based on investigator reported data.

2Medtronic, Inc. website and VEITH 2013 session, data presented by Marc Sambeek

3Verhoeven EL, Katsargyris A, Bachoo P, Larzon T, Fisher R, Ettles D, et al. Real world performance of the new C3 Gore Excluder Stent-Graft. Eur J Vasc

Endovasc Surg. 2014 Aug;48(2):131-7.

4Endologix Investor Presentation, November 2014. Data presented by Andrew Holden.

European Post-Market Registries Comparative 30 Day Safety / Performance Data

10 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or

on the order of a physician.

TriVascular OVATION1

Medtronic ENGAGE2

Gore GREAT3

Endologix EVAS FORWARD4

Patients Enrolled 501 1263 400 300

Safety (Treatment to 30 days)

Rupture 0.2% (1/501) Not Reported Not Reported Not Reported

Conversion to Open Repair 0.0% (0/501) Not Reported 0.5% (2/400) 0.3% (1/289)

AAA-Related Reintervention 2.6% (13/501) 1.6% 0.5% (2/400) 3.5% (10/289)

Performance (1 Month Follow-Up) Type I and III Endoleaks 1.1% (5/454) 1.5% Not Reported 0.3% (1/289)

Migration 0.0% (0/440) Not Reported 0.0% (0/400) Not Reported

LINC 2015 |

TriVascular OVATION1

Medtronic ENGAGE2

Gore GREAT3

Patients Enrolled 501 1263 400

Safety (Treatment to 1 Year)

Rupture 0.2% (1/501) 0.2% (2/1263) 0.3% (1/400)

Conversion to Open Repair 0.2% (1/501) 0.6% (7/1263) 0.5% (2/400)

AAA-Related Reintervention 7.0% (35/501) 5.6% (71/1263) 7.0% (28/400)

Performance (1 Year Follow-Up) Type I and III Endoleaks 1.6% (6/384) 0.6% (6/1072) 1.0% (4/400)

Migration 0.3% (1/378) 0.0% (0/1242) 0.0% (0/400)

European Post-Market Registries Comparative 1 Year Safety / Performance Data

11 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or

on the order of a physician.

1Results as of January 6, 2015 based on investigator reported data.

2Endovascular Today Supplement December 2013 sponsored by Medtronic, Inc.

3Verhoeven EL, Katsargyris A, Bachoo P, Larzon T, Fisher R, Ettles D, et al. Real world performance of the new C3 Gore Excluder Stent-Graft. Eur J Vasc

Endovasc Surg. 2014 Aug;48(2):131-7.

LINC 2015 |

Pre op Aortic Views

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©2011 TriVascular, Inc. All Rights Reserved. Device not for commercial distribution in the U.S.A.

RPO PA LPO

LINC 2015 |

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Conclusion

• Over 5000 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

– 501 patients enrolled in the OVATION Post Market Registry

• A Post-Approval Study in the US will follow patients for 5 years

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

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LINC 2015 |

Conclusion

• OVATION Post Market Registries has reported encouraging clinical results in a real-world experience

• Safety and Performance outcomes at 1 year are promising , even for more challenging patient anatomies given a broader Intention for Use.

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LINC 2015 |

Real World Experience The Ovation Prime® Stent

Graft System

Marc Bosiers Koen Deloose Joren Callaert

A.Z. Sint-Blasius, Dendermonde

Imelda Hospital, Bonheiden

Patrick Peeters Jürgen Verbist

W. Van den Eynde

OLV Hospital, Aalst

Lieven Maene Roel Beelen

R.Z. Heilig Hart, Tienen

Koen Keirse Bart Joos

Patrick Peeters, MD Chief. Dept. of Surgery

Chief. Dept Cardio-Vascular & Thoracic Surgery Imelda Hospital Bonheiden (Belgium)

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