Early experience with the new Bolton TREO abdominal

stent-graft

Ciro Ferrer, MDFisiopatologia Chirurgica ad Interesse Vascolare

Sapienza Università di RomaDirettore: Prof. L. di Marzo

Disclosure

Speaker name:

Ciro Ferrer

I have the following potential conflicts of interest to report:

Consulting: Bolton Medical

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

X

Stentgraft design

Adjustable leg landing zones for versatile treatment and adjustment to the distal landing zone

30mm Ipsilateral

Adjustable Zone

10mm Contralateral

Adjustable Zone

Active FIXATION within stent modules with the unique Lock-Stent to avoid modular disconnection

IpsilateralLock Stent

ContralateralLock Stent

1

2

LOCK STENT TECHNOLOGHY

Rounded barbs located at the base of

main body lock stent are designed

specifically to engage with leg

extensions to add resistance against

module disconnection and deliver safe

variable distal adjustment

LOW PROFILE DELIVERY SYSTEM

ADVANCED

HEMOSTASIS VALVE

Double valve mechanisms, one passive

and one active with 10 different positions,

secures hemostasis

TWO WAY FLUSH PORT

DETACH MECHANISM

DETACHABLE SHEATH

The sheath detaches from the Delivery

System providing less access vessel

manipulation and quicker access

PRECISE DELIVERY SYSTEM

The mechanical deployment provides

controlled and stable stent- graft deployment

MAIN BODY D.S. LEG EXTENSION D.S.

30 to 36mm 20 to 28mm 9 to 15mm 17 to 24mm

19 F. (OD) 18 F. (OD) 13 F. (OD) 14 F. (OD)

The overlap of the two first proximal stents provides optimal sealing even in tortuous anatomies

• TREO is indicated in neck lengths of:

– 10 mm or greater with an infrarenal angle of less than 60 degrees

– 15 mm or greater with an infrarenal angle between 60 and 75 degrees

10mm

Male, 67 yoHypertensionHyperlipidemiaCAD (previous PTCA)

Vessel analysis

10 mm

Bolton TREO is the only designed with both suprarenal and infrarenal active fixation

SUPRARENAL FIXATION

Suprarenal laser cut barbs allow for

primary proximal fixation once deployed

INFRARENAL FIXATION

Infrarenal laser cut barbs provides

supplemental fixation. Forces increases

proportionally with the infrarenal angulation

The infrarenal barbs highly contribute to migration resistance in large angulated necks

Infrarenal Barb Contribution Alone

6.41 N

Small Angle Large Angles

1-2 Barbs Engaged

5.9 N 9.75 N50% Increase

12.88 N100% Increase

Straight

SUPRARENAL FIXATION

Suprarenal barbs are completely covered

during deployment until release of the

bare stent

INFRARENAL FIXATION

Infrarenal barbs are obscured in

“valleys” prior to final deployment

Male, 80 yoHypertensionPrevious pulm lobectomyAtrial fibrillation

Enhanced DeliveryTREO’s Proximal Clasp

Forward Movement Required to Recapture

Recapture Avoided

Endurant II & IIs are known for snagging during system removal

TREO’s proximal clasp is designed to smoothly remove and not snag on the

bare stent.

Enhanced DeliveryTREO’s Proximal Clasp

RATIONALE REGISTRY

STUDY DEFINITION

A Post-Market Surveillance Clinical Registry

STUDY DESIGN

- Prospective

- Multicentric

- International

- EDC (Electronic Data Capturing) System

RATIONALE REGISTRY

PRIMARY ENDPOINT

Safety: Mortality & Morbidity (Stroke, MI, Renal Failure, Respiratory

complications, paraplegia, ischemia)

Efficacy: Aneurysm related mortality

SECONDARY ENDPOINT

Delivery / Deployment; Migration; Patency; Integrity; Endoleak; Aneurysm Sac

Size Changes; Limb Ischemia; Vascular Access Complications; Unintentionally

covering renal arteries and / or hypogastric arteries

• PARTICIPANTS

• 17 Countries• 12 Europe

• 3 Asia

• 2 Latin America

• 32 Sites

• 202 Patients enrolled

GLOBAL REGISTRY

SITES BY REGION

3 3

26

26 Europe

3 Asia

3 Latin America

Europe

EUROPEAN INSTITUTIONS

DE - Bonifatius Hospital Lingen

DE - Theresienkrankenhaus und St. Hedwig-Klinik

DE - Universitätsklinikum Tübingen

DE - Deutsches Herzzentrum Berlin

IT - Casa Di Cura Villa Dei Fiori

IT - Azienda Ospedaliera San Camillo Forlanini

IT – Azienda Ospedaliera Universitaria Senese

UK - Manchester Royal Infirmary. Central Manchester University Hospitals

UK - John Radcliffe Hospital. Oxford UniversityHospitalsUK - Addenbrooke's Hospital. Cambridge UniversityHospitals

UK - Hospital Germans Trias i Pujol Hospital

ES - Hospital Clinic Barcelona

ES - Complexo Hospitalario Universitario de Ourense

ES - Hospital Universitario Ramón y Cajal

ES - Hospital HM Modelo

NL - ZiekenhuisGroep Twente

NL - University Medical Center Utrecht

PL - Samodzielny Publiczny Szpital Kliniczny Nr 1 in Lublin

GR - Georgios Gennimatas" Thessaloniki General Hospital

GR - Evangelismos General Hospital

HU - Semmelweis Medical University Budapest

SE - Karolinska University Hospital

SE - Linköping University Hospital

IR - Cork University Hospital

DK - Rigshospitalet, National Hospital and University ofCopenhagen

NO - Haukeland University Hospital

Latin American

Asia

CL - Hospital Barros Luco Trudeau

CL - Fondo Hospital Dirección Previsión de Carabineros Dipreca

VE - Urológico San Román

HK - The University of Hong Kong

VN - Ray Hospital

TH - Lampang Hospital

INTERNATIONAL INSTITUTIONS

Number patients included at Follow-Up N %

1 Month FU 194 96,0

OUTCOMES

1 Month FU 6 Month FU 12 Month FU

6 Month FU 72 35,6

12 Month FU 31 15,3

Complications

Implant

N = 202 (%)

1 Month FU

N = 194 (%)

Device Integrity Maintained 202 (100) 194 (100)

Conversion to Surgery 0 (0) 0 (0)

Stent graft Migration ≥ 10 mm 0 (0) 0 (0)

Graft Patency 202 (100) 194 (100)

Mortality N

Aneurysm Related Mortality 0

Non Aneurysm Related Mortality 0

All Cause Mortality 0

Mortality and major adverse events

Endoleak Type 1 monthN = 194 (96%)

Type Ia 2 (1,0)

Type Ib 2 (1,0)

Type II 26 (12,4)

Type III 0 (0)

Others 0 (0)

Total 30 (13,4)

ENDOLEAK RATE AT FOLLOW-UP

Endoleak

60

50

N=1

9459,2 mm55

55,9mm

Screen 1 month VISIT

MAXIMUM DIAMETER OF LESION: Mean Values (mm)

mm

65

N=202

Aneurysm Sac Size Changes

- 96% technical success

- At 1 month 2% type I endoleak with 0% type III & IV

- 0% mortality and migration at 30 days

- 14% sac decrease at 6 months

- At 6 months no conversion to surgery, no migration, tears nor fractures

- No procedure-related mortality

RATIONALE REGISTRY

Customized solutions available within theTreo custom made program

CUSTOM SOLUTIONS

Current available designs

• Tapers

• Reverse/Extreme Tapers

• Extreme Lengths

• Scallop

• Single Fenestration

Future available designs

• Double Fenestration

• Double Fenestration w/Scallop

DELIVERY TIME

3 weeks (From design approval to delivery)

Courtesy of Prof. Carlo SetacciAzienda Ospedaliera Universitaria Senese

Early experience with the new Bolton TREO abdominal

stent-graft

Ciro Ferrer, MDFisiopatologia Chirurgica ad Interesse Vascolare

Sapienza Università di RomaDirettore: Prof. L. di Marzo