Addressing Unmet Clinical Needs With A New Generation ...€¦ · Addressing Unmet Clinical Needs...

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Addressing Unmet Clinical Needs With A New Generation TEVAR Device: Practical Application of the Valiant Navion Theodoros Kratimenos, MD Athens, Greece

Transcript of Addressing Unmet Clinical Needs With A New Generation ...€¦ · Addressing Unmet Clinical Needs...

Page 1: Addressing Unmet Clinical Needs With A New Generation ...€¦ · Addressing Unmet Clinical Needs With A New Generation TEVAR Device: Practical Application of the Valiant Navion Theodoros

Addressing Unmet Clinical Needs With A New Generation TEVAR Device: Practical

Application of the Valiant Navion

Theodoros Kratimenos, MD

Athens, Greece

Page 2: Addressing Unmet Clinical Needs With A New Generation ...€¦ · Addressing Unmet Clinical Needs With A New Generation TEVAR Device: Practical Application of the Valiant Navion Theodoros

Disclosure

Speaker name:

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

I have the following potential conflicts of interest to report:

✓ Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

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Descending

Opportunities To Innovate In The Thoracic Aorta Are Significant

Thoracic aortic disease represents a significant opportunity to serve patients

ANEURYSM DISSECTION

Ascending

Arch

60%

40%

67%

33%

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Descending

Opportunities To Innovate In The Thoracic Aorta Are Significant

Thoracic aortic disease represents a significant opportunity to serve patients

Historically, TEVAR devices have been designed for aneurysmal disease

ANEURYSM DISSECTION

Ascending

Arch

60%

40%

67%

33%

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Descending

Opportunities To Innovate In The Thoracic Aorta Are Significant

Thoracic aortic disease represents a significant opportunity to serve patients

Historically, TEVAR devices have been designed for aneurysmal disease

We need:

• tailored proximal configurations,

• lower profile devices,

• enhanced conformability and navigability,

• better graft compliance with broader sizing options

ANEURYSM DISSECTION

Ascending

Arch

60%

40%

67%

33%

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Valiant Navion is a single TEVAR System for all lesions of the Descending Thoracic Aorta

PAU-IMH

TBAD

TAA

BTAI

Valiant Navion

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Valiant Navion FreeFlo and

CoveredSeal configuration

options

TAA And PAUTAA and PAU

18 20

22

22 24

25

Longer stent

graft lengths up

to 225 mm

Navion

Captivia

Navion Captivia

FreeFlo CoveredSeal

Shorter nose cone

Lower crossing profile delivery

system

Lower porosity fabric

Accurate distal deployment

Navion Captivia

Ext. Iliacs<6mm and Com.

Iliacs heavily calcified

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Type B Aortic Dissection And IMH (Fragile Aortic Pathologies)

Valiant Navion CoveredSeal configuration

TBAD/IMHGreater tapering of

5 and 6 mm

≥ 2.5 cm proximal

landing zone

13 mm 10 mm

“W” stent on outside aids in vessel

apposition

“W” stent allows for graft material

support between internal stents to

enhance apposition and seal

“A tapered stent graft should be preferred

for the majority of patients with dissection”

Pantaleo et. al. Ann Thor Surg 2016; 102:527-33

Fragility of the aortic wall is risk factor for

stent graft induced new entry tear

Infolding resistanceApposition and Seal

6 months F-UP

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Data file on Medtronic

Type B Aortic Dissection And IMH

“Soft touch” for decreased vessel trauma

CoveredSeal’s proximal stent is

fully enclosed within the graft

Tip capture mechanism

Lower radial pressure

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When I Use The CoveredSeal Configuration In My Practice

Pathology-specific (fragile aortas) where having no exposed metal might be preferred

Dissection

IMH

Anatomical situations

FreeFlo might land underneath supra-aortic vessel; bovine arch

When you need to build from bottom-up

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Blunt Traumatic Aortic Injury (BTAI)

BTAI

18 20

22

Deliver to target

Option of no exposed proximal stent

Shorter nose cone

Lower crossing profile delivery

system

Smaller diameter stent graft size option:

20mm

New deployment

techniqueDeploy at target

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Conclusions

• The simple 3 steps deployment sequence of the Valiant Navion system

meets the need of reduced manipulation during TEVAR (operator friendly)

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• The simple 3 steps deployment sequence of the Valiant Navion system

meets the need of reduced manipulation during TEVAR

• The unique CoveredSeal configuration allows for better customization of

treatment for different anatomical scenarios and pathologies

Conclusions

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Conclusions

• The simple 3 steps deployment sequence of the Valiant Navion system

meets the need of reduced manipulation during TEVAR

• The unique CoveredSeal configuration allows for better customization of

treatment for different anatomical scenarios and pathologies

• Post Market Registry data to be collected on fragile aorta patients, TBAD,

IMH, etc., to better understand outcomes regarding these complex patient

populations

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• The simple 3 steps deployment sequence of the Valiant Navion system

meets the need of reduced manipulation during TEVAR

• The unique CoveredSeal configuration allows for better customization of

treatment for different anatomical scenarios and pathologies

• Post Market Registry data to be collected on fragile aorta patients, TBAD,

IMH, etc., to better understand outcomes regarding these complex patient

populations

• The Navion platform represents an advancement in TEVAR therapy and

device design and that allows physicians to treat more patients safely

Conclusions

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Addressing Unmet Clinical Needs With A New Generation TEVAR Device: Practical

Application of the Valiant Navion

Theodoros Kratimenos, MD

Athens, Greece