TriVascular Ovation Prime System Expanding EVAR Safely · TriVascular Ovation Prime® System –...

LINC 2015 |

TriVascular Ovation Prime® System – Expanding EVAR Safely

Thomas Nolte, MD

Herz und Gefaßzentrum Bad Bevensen, Germany

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

LINC 2015 |

Disclosure

Thomas Nolte:

.................................................................................

I have the following potential conflicts of interest to report:

Consulting

√

LINC 2015 |

What a Beauty!

LINC 2015 |

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

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

Ovation Prime® Abdominal Stent Graft

4 ©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

LINC 2015 |

Ovation® Global Pivotal Trial A pivotal clinical evaluation of the safety and effectiveness of the TriVascular Ovation Abdominal Stent Graft System

• Primary Endpoint

– MAE within 30 days of the procedure as determined by clinical events committee

• Primary Effectiveness Endpoint

– Successful Delivery and Deployment – Freedom from Rupture and Conversion to Open Surgical Repair – Freedom from Type I and III Endoleaks, Migration, and Enlargement

as determined by Core Lab

• Follow-up: 1 month, 6 month and annual to 5 years

©2015 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 5

LINC 2015 |

• AAA max.Ø ≥ 5.0 cm

• Ø increase ≥ 5 mm in 6 months

• Ø exceeds aortic diameter by 1.5

• Proximal Landing Zone: – ≥ 7 mm

– 16 to 30 mm ID

– ≤ 45° angle (neck < 10 mm)

– ≤ 60° angle (neck ≥ 10 mm)

Ovation Global Pivotal Trial Selected Inclusion Criteria


• Distance from lowest RA to hypogastric

• ≥ 130 mm

Distal Iliac landing zone: ≥ 10 mm 8 to 20 mm ID#

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Investigator Site

Botti, Charles Riverside Methodist Hospital

Cheema, Mohiuddin Hartford Hospital

Clair, Daniel Cleveland Clinic

Eidt, John Central Arkansas VA

Eskandari, Mark Northwestern Memorial

Glickman, Mark Sentara Medical Group

Gray, Bruce Greenville Hospital

Haser, Paul UMDNJ

Hassoun, Heitham Methodist Hospital

Henretta, John Mission Hospital

Hodgson, Kim Southern Illinois University

Jain, Ash Washington Hospital

Jicha, Douglas Santa Rosa Memorial

Jones, Paul Mercy Medical Center

Jordan, William UAB

Kasirajan, Karthik Emory University

Krajcer, Zvonimir St. Luke’s Hospital

Laird, John UC Davis

Maini, Brijeshwar Moffitt Heart and Vascular

Makaroun, Michel UPMC

Maldonado, Thomas NYU Hospital

Mehta, Manish Albany Medical Center

Mishkel, Gregory Prairie Heart

Moore, Wesley UCLA

Motew, Stephen Forsyth Medical Center

Murkherjee, Dipankar Inova Fairfax Hospital

Rizvi, Adnan Minneapolis Heart Institute

Sternberg, Charles Ochsner Health System

Investigator Site

Brunkwall, Jan Uni. Klinik Koln

Krankenberg, Hans Medizinisches Versorgungszentrum, HH

Mathias, Klaus Klinikum Dortmund

Nolte, Thomas Herz und Gefaßzentrum, Bad Bevensen

Scheinert, Dierk Park Krankenhaus, Leipzig

Sievert, Horst CVC, Frankfurt

Torsello, Giovanni St. Franziskus-Hospital, Münster

Investigator Site

Valdes, Francisco Catholic University

161 patients across 36 sites enrolled in Chile, Germany and USA • Chile: 20 patients / 1 site • Germany: 30 patients / 7 sites • USA: 111 patients / 28 sites

Ovation Global Pivotal Trial Enrolling Institutions


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Patient Medical History1 Global (N=161)

Germany (N=30)

ASA Grade III or IV 66.5% (107/161) 26.7% (8/30)

Hypertension 84.5% (136/161) 73.3% (22/30)

Hyperlipidemia 70.2% (113/161) 46.7% (14/30)

Smoking History 70.2% (113/161) 60.0% (18/30)

Coronary Artery Disease 44.7% (72/161) 30.0% (9/30)

Chronic Obstructive Pulmonary Disease (COPD)

27.3% (44/161) 23.3% (7/30)

Ovation Global Pivotal Trial Baseline Patient Characteristics


1Conditions listed with frequency ≥25% in global population 2Imaging core lab reported measurements 3Investigator reported measurements 4Measurement @ 13mm distal to distal renal artery

Patient Aortoiliac Characteristics2 Global (N=161)

Germany (N=30)

Proximal Neck Length, mm3,4 23.0 ± 12.5 24 ± 11

Proximal Neck Diameter, mm3 22.7 ± 3.1 23 ± 3

Juxtarenal Angle, degrees 19.1 ± 13.5 19 ± 17

Maximum Aneurysm Diameter, mm 53.6 ± 9.0 55 ± 11

Left Minimum Iliac Access Diameter, mm 7.0 ± 1.6 7.2 ± 1.9

Right Minimum Iliac Access Diameter, mm 7.0 ± 1.6 7.5 ± 1.7

Patient Demographics Global (N=161)

Germany (N=30)

Bad Bevensen (N=295)

Age, yr 73 ± 8 72 ± 6 72 ± 8

Gender 87.6% (141/161) 90.0% (27/30) 87 % (37/295)

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Ovation Global Pivotal Trial 3 Year Results @ July 25 2014


Safety1 Global 731 to 1095 Days

Germany 731 to 1095 Days

Rupture 0/154 0/27

Conversion to Open Repair 0/154 0/27

Limb Occlusions2 0/154 0/27

Effectiveness3 Global 3 Years

Germany 3 Years

Type I and III Endoleaks 0/106 0/23

Migration 0/113 0/23

1Rupture and Conversion to Open Repair based on investigator reports 2Limb Occlusions defined as re-interventions due to limb occlusion 3 Endoleaks and Migration rates based on Core Lab Data (M2S) 4Type II endoleaks reported in all cases of AAA Enlargement.

Aneurysm Assessment4 Global 3 Years

Germany 3 Years

Stable or Decrease (≥5mm) 100/113 20/23


Expanding EVAR Safely: Still open Questions?

LINC 2015 |

Durability of Ovation System’s Seal

Patients treated with the Ovation™ system had no neck dilatation and no late Type I endoleaks at 3 years.4

1 Rodway Eur J Endovasc Surg 2008; 35: 685-93 EVAR: N=67, Open: N=56 2 Monahan JVS 2010: 52: 303-7 N=46 3 Core Lab measurements, Ovation Global Pivotal Study N=131 4 Neck dilatation in proximal neck defined as growth > 2mm at renals, 10mm below renals, and 15 mm below renals; N=131

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LINC 2015 |

CASE STUDY REVIEW


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• Patient History:

• 53 year old male – Obesity

– mild anemia of unknown origin

• AAA max. Ø 62 mm – neck length: 30 mm

– angulation: 55°

– Ø @ 13mm: 27 mm

• Pre-operative images

Case Study- 1


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Follow Up: (Post-Market-Study)


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FDG-PET-CT For Pulmonary Nodes


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Autopsy after sudden Death @ 23 Months

• Bled to death for undiagnosed AADA

• entry supracoronary, reentry above Ovation crown

• Root cause:

– Giant cell arteritis • explains PET-CT findings!

– no pulmonary cancer

– would steroids have changed the fate?


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• 77 year old female – CRI III

• AAA max. Ø 53 mm – perirenal pathology

– neck length: 0 mm

– angulation: 8°

– Ø @ 13mm: 29 mm


Case Study- 2


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OVATION Stent Graft: 34mm MB


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Follow-Up: (Post-Market-Study)


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Postop: @ 36 Months


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Conclusion:

• suprarenal pathology prevented from safe fixation

– barbs never ever caught the aortic wall

– migration

• no endoleakage, sac stable

• 80 years old, CRI

• fenestrated graft as option


LINC 2015 |


• 78 year old female – smoker

– left mastectomy for cancer 2007

• AAA max. Ø 57mm – neck length: 3 mm

– angulation: 33°

– Ø @ 13mm: 29/34 mm


Case Study- 3


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OVATION PRIME Graft: 34mm MB + Stent


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Follow-Up: (Post-Market-Study)


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Postop: @ 30 Months


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Conclusion:


• persistent sac and neck-enlarge

ment with loss of wall contact of the sealing rings

• stable fixation

• no evidence of type 1 or 3 endoleak

Root cause:

• persistent type 2 endoleak after previous ONYX-embolisation

• second embolisation planned

LINC 2015 |

Summary

• Ovation Prime System has proven safe and stable results in the Global Pivotal Study over 3 Years now.

• The Ovation Prime sealing ring preserves the aortic neck with an innovative, less-invasive, clinically proven solution for the broadest range of AAA anatomies.

• Usage for iuxta- and perirenal Aneurysms should be considered with care, especially in elderly women


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LINC 2015 |

TriVascular Ovation Prime® System – Expanding EVAR Safely

Thomas Nolte, MD

Herz und Gefaßzentrum Bad Bevensen, Germany


TriVascular Ovation Prime System Expanding EVAR Safely · TriVascular Ovation Prime® System –...

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