Endurant II - Medtronic - Endovascular Therapies International

www.medtronicendovascular.com
Medtronic Vascular, Inc.
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USA
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UC201201570 EE © Medtronic, Inc. 2011. All Rights Reserved. Printed in Europe. Not for distribution in the USA.
Innovating for life.

Single-piece, laser-cut
nitinol stent with anchor
pins for suprarenal fixation
Controlled release
Endurant II carries forward the proven
performance of Endurant, while introducing
a lower profile * and additional limb lengths
for enhanced ease of use.
Improved radiopacity for
increased visibility †
Low-profile, hydrophilic
delivery system for
enhanced access
Longer limb lengths
offer multiple options
High-density,
multifilament polyester
graft material
Tip capture for
accurate deployment
* 28 mm aortic stent graft
2 ENDURANT II AAA STENT GRAFT SYSTEM
† Contralateral gate marker
3

LOWER PROFILE
ENHANCED ACCESS
Endurant II takes improved access a step further, offering an 18 F crossing profile
for its 28 mm bifurcated device. With extended hydrophilic coating, the same
thin-walled graft cover and flexible, kink-resistant delivery system as Endurant,
Endurant II delivers improved ease of use.
BIFURCATED AAA DEVICE OUTER DIAMETER PROFILES
28 mm Medtronic Endurant II, Cook Zenith Bifurcated Devices and 28.5 mm Gore Excluder Bifurcated Device
Crossing Profile (OD) 18 F 20 F 1 23 F 2
Hydrophilic Coating
Sheath Required
Medtronic
Endurant II
Yes
No
Gore
Excluder
No
Yes
Cook
Zenith
Yes
Yes
100%
delivery/deployment
success 3
Hydrophilic coating extends 35% further down the catheter to facilitate stent graft delivery 4
BIFUR DIAMETER
28mm, 25mm, 23mm 18F (OD) *
36mm, 32mm 20F (OD) *
LIMB DIAMETER
16mm, 13mm, 10mm † 14F (OD) *
28mm, 24mm, 20mm 16F (OD) *
*Outer diameter
† All 156 & 199 mm limbs are 16 F
1. Bench test data on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance. The Gore Excluder IFU recommends using an
18 F Gore Introducer Sheath with its 28.5 mm Gore Excluder bifurcated main body device. The Gore DrySeal Sheath IFU indicates that the nominal
OD of an 18 F Gore DrySeal Sheath is 6.8 mm, which is 20.4 F.
2. Bench test data on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance. Cook’s Physician Manual indicates that the
OD of a 28 mm Cook Zenith bifurcated main body device is 7.7 mm, which is 23.1 F.
3. Delivery Success = successful vascular access and delivery of the device to the intended anatomical treatment site. Deployment Success = successful
deployment of the device in the intended site and the successful removal of the delivery system. Endurant EU trial: Rouwet EV et al. Final results
of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg.
2011;42(4):489–497.
4 ENDURANT II AAA STENT GRAFT SYSTEM
4. Endurant II features 50.8 cm hydrophilic coating.
5

COMPLETE CONFORMABILITY
OPTIMAL SEAL
In treating a wide variety of anatomies, conformability and seal promote success.
With super-elastic nitinol stents, Endurant II conforms to tortuous iliac arteries
and highly angulated necks. *
1. Limb stent and spacing
between stents conform to
anatomy to reduce kinking
2.
M-shaped proximal stents
provide wall apposition
and minimise infolding
1
Treat necks as
short as
10mm
and angulation up to
75°†
Type 1 Endoleak
0.0%*
after one year
* EU Trial, US IDE and ENGAGE Registry studied the Endurant AAA Stent Graft System.
† Please refer to the product Instructions For Use for details. The Endurant II AAA Stent
Graft System is indicated for use in patients with a proximal aortic neck ≥ 15 mm in
length with ≤ 75° infrarenal and ≤ 60° suprarenal angulation, a proximal neck ≥ 10 mm
6 ENDURANT II AAA STENT GRAFT SYSTEM
in length with ≤ 60° infrarenal and ≤ 45° suprarenal angulation.
7
2
PRE
POST
Pre-procedure and one-month follow-up of
Endurant AAA Stent Graft

CONSISTENT PRECISION
CONTROLLED DEPLOYMENT
An advanced delivery system makes Endurant II simple to place in
straightforward and challenging anatomies. With control at every step,
you can approach more targets with confidence. *
A backend thumb wheel provides
controlled release of the suprarenal
stent and anchor pins.
Aim accurately with four proximal markers
Easy contralateral limb placement with the flow divider marker
Facilitate gate cannulation with improved
radiopacity of contralateral gate marker
* EU Trial, US IDE and ENGAGE Registry studied the Endurant AAA Stent Graft System.
Tip capture for
precise positioning
adjustments, including
adjustment of placement
proximally or distally, even
after deployment of
three stent rings. †
e-shaped marker assists
with A/P orientation
8 ENDURANT II AAA STENT GRAFT SYSTEM
† Please refer to the product Instructions For Use for details.
9

DuRABLE DESIGN
DEPENDABLE PERFORMANCE
Featuring a suprarenal stent with anchor pins laser-cut from a single piece of nitinol
and high-density polyester graft material, Endurant II is built for durability, with the
quality you’ve come to expect. *
1. High-density, multifilament
polyester graft material
provides lower porosity
for resistance against
Type IV endoleaks
2. Ultra-high molecular
weight polyethylene
sutures are three
times stronger than
surgical sutures
1
10 ENDURANT II AAA STENT GRAFT SYSTEM
With AAA EVAR Devices And How Are They Helping In Patient Treatment), VEITH 2011.
11
2
3
0.0%†
Migration at 2 Years
BEFORE
POLISHING
Suprarenal stent
with anchor pins
laser-cut from a
single piece of
nitinol provides
secure fixation
3. Electropolished
nitinol stent for
greater strength
* EU Trial, US IDE and ENGAGE Registry studied the Endurant AAA Stent Graft System.
† Proximal migration is observed when the stent graft covers a renal artery or moves > 10 mm.
Distal migration is observed when the stent graft moves > 10 mm relative to fixed anatomic
landmarks. Makaroun M., US IDE 2-Year Presentation (What Improvements Have Occurred
AFTER
POLISHING

CLINICAL DATA
BuILDING CONFIDENCE
CONSISTENTLY LOW EVENT RATES. TRIAL AFTER TRIAL. 1
EvEnT RATEs AT 30 DAYs ACROss 1400+ PATIEnTs
Eu TRIAL
(N = 80)
uS IDE
(N = 150)
ENGAGE REGISTRY 4
(N = 1200)
Trial Study
Design
Prospective, open-label,
multicenter trial conducted
at 10 sites across Europe
Prospective, multicenter trial
conducted at 26 sites across
the United States. Reviewed
by independent core lab
Post-market, real-world
registry involving 1200+
patients and 80+ countries
across six continents
Technical /
Deployment
Success 2
(%)
Type I
Endoleak 3
(%)
100 0
99.3 0
99.4 1.2
ENDURANT EU trial: Rouwet EV et al. Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair.
Eur J Vasc Endovasc Surg. 2011;42(4):489–497.
ENDURANT US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant stent graft system. J Vasc Surg. 2011;54:601–608.
ENGAGE Registry
Schermerhorn M. ENGAGE 30-day and 1-year results, VIVA 2011.
EnDURAnT II InDICATIOns 5
Prox Neck Length ≥ 10 mm with Infrarenal Angulation ≤ 60 and Suprarenal Angulation ≤ 45
Prox Neck Length ≥ 15 mm with Infrarenal Angulation ≤ 75 and Suprarenal Angulation ≤ 60
1. EU Trial, US IDE and ENGAGE Registry studied the Endurant AAA Stent Graft System.
2. EU Trial delivery success = successful vascular access and delivery of the device to the intended anatomical treatment site; EU Trial deployment success = successful
deployment of the device in the intended site and the successful removal of the delivery system; US IDE deployment success = “successful stent graft implant.”
3. 30 Day EU Trial data represents follow-up on N = 79 patients. 30 Day US IDE data represents follow-up on N = 130 patients.
4. 30 Day ENGAGE data represents follow-up on N = 1194 patients.
5. Endurant II IFU
EvEnT RATEs AT 1 YEAR
12 ENDURANT II AAA STENT GRAFT SYSTEM
12. Based on preliminary data received for 96% of eligible subjects at 2 years
13
Eu TRIAL
(N = 80)
(%)
uS IDE
(N = 150)
(%)
ENGAGE
Registry
(N = 1200) 6
(%)
Type I endoleak 7 0 0 0
Migration 8 0 0 0
Aneurysm sac diameter:
decrease or stable
97.3 100 97
Conversion to surgery 0 0 0.9
Aneurysm-related mortality
(ARM) 9 Not Reported * 0 1.8
0% Post-Operative Rupture at 1 Year 10
* Freedom from All-Cause Mortality at 1 Year, the primary endpoint of clinical success was achieved in 95% of patients.
6. 1 Year ENGAGE data represents follow-up on N = 350 patients.
7. 1 Year EU Trial data represents follow-up on N = 77 patients. 1 Year US IDE data represents follow up on N = 130 patients. ENDURANT EU trial: Rouwet EV et al.
Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2011;42(4):
489–497. ENDURANT US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant stent graft system. J Vasc Surg. 2011;54:601–608.
8. Proximal migration is observed when the stent graft covers a renal artery or moves > 10 mm. Distal migration is observed when the stent graft moves
> 10 mm relative to fixed anatomic landmarks.
9. Aneurysm-related mortality is reported as “freedom from ARM” in the EU Trial.
10. Endurant EU Trial: E.V. Rouwet et. al. Final Results of the Prospective European Trial, Eur J Vasc Endovasc Surg, 2011 and Endurant US IDE Trial: M. Makaroun.
One year outcomes of the US regulatory trial of the Endurant Stent Graft System. J Vasc Surg 2011; 54:601-8.
COnsIsTEnTLY LOW EvEnT RATEs AT 2 YEARs 11
uS IDE TRIAL: 2 YEAR RESuLTS 12
Freedom from Secondary Procedure (N = 137) 93.9%
Migration (N = 105) 0%
Conversion to Surgery (N = 136) 0%
Aneurysm-Related Mortality (N = 144) 0%
11. Makaroun M., US IDE 2-Year Presentation (What Improvements Have Occurred With AAA EVAR Devices And How Are They
Helping In Patient Treatment), VEITH 2011.

COMPONENT PLACEMENT GuIDE
40 * , 50 mm
70 * , 80 mm
BIFURCATED GRAFT
124 * , 145, 166 mm
AORTIC ExTEnsIOn / ABDOMInAL TUBE
49, 70 mm
23, 25, 28,
32, 36 mm
AORTIC ExTEnsIOn PROxIMAL MARkERs
23, 25, 28,
32, 36 mm
ILIAC ExTEnsIOn
82 mm
ILIAC ExTEnsIOn
10, 13,
20, 24,
28 mm
P R O x I M A L M A R k E R s
10, 13,
20, 24,
28 mm
MInIMUM 3
sTEnT OvERLAP
MInIMUM 3
sTEnT OvERLAP
BIFURCATED PROxIMAL MARkERs
23, 25, 28,
32, 36 mm
13, 16,
20 mm
12,
14 mm
16 mm
COnTRALATERAL LIMB
PR O x I M A L M A R k E R s
10, 13,
16, 20, 24,
28 mm
COnTRALATERAL LIMB
82, 93, 124, 156, 199 mm
COnTRALATERAL LIMB
82, 93, 124, 156, 199 mm
16 mm
COnTRALATERAL LIMB
PR O x I M A L M A R k E R s
10, 13,
16, 20, 24,
ALIGn MARkERs
AUI PROxIMAL MARkERs
23, 25, 28,
32, 36 mm
14 mm
AUI GRAFT
102 mm
DIsTInCT RADIOPAqUE MARkERs
• Radiopaque markers
• e-shaped proximal markers
— Internal ring marker—only seen under fluoroscopy
* Measurements for 124 mm length bifurcated stent graft
ENDuRANT II PRODuCT CODES
BIFURCATIOns
14 ENDURANT II AAA STENT GRAFT SYSTEM
28 mm
15
Proximal
Graft
Diameter
(mm)
Product Code
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETBF 23 13 C 124 EE 18
ETBF 23 13 C 145 EE 18
ETBF 23 13 C 166 EE 18
ETBF 23 16 C 124 EE 18
ETBF 23 16 C 145 EE 18
ETBF 23 16 C 166 EE 18
ETBF 25 13 C 124 EE 18
ETBF 25 13 C 145 EE 18
ETBF 25 13 C 166 EE 18
ETBF 25 16 C 124 EE 18
ETBF 25 16 C 145 EE 18
ETBF 25 16 C 166 EE 18
ETBF 28 13 C 124 EE 18
ETBF 28 13 C 145 EE 18
ETBF 28 13 C 166 EE 18
ETBF 28 16 C 124 EE 18
ETBF 28 16 C 145 EE 18
ETBF 28 16 C 166 EE 18
ETBF 28 20 C 124 EE 18
ETBF 28 20 C 145 EE 18
ETBF 28 20 C 166 EE 18
ETBF 32 16 C 124 EE 20
ETBF 32 16 C 145 EE 20
ETBF 32 16 C 166 EE 20
ETBF 32 20 C 124 EE 20
ETBF 32 20 C 145 EE 20
ETBF 32 20 C 166 EE 20
ETBF 36 16 C 145 EE 20
ETBF 36 16 C 166 EE 20
ETBF 36 20 C 145 EE 20
ETBF 36 20 C 166 EE 20
ILIAC ExTEnsIOns
Proximal
Graft
Diameter
(mm)
Product Code
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETEW 10 10 C 82 EE 14
ETEW 13 13 C 82 EE 14
ETEW 20 20 C 82 EE 16
ETEW 24 24 C 82 EE 16
ETEW 28 28 C 82 EE 18
AUI
Proximal
Graft
Diameter
(mm)
Product Code
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETUF 23 14 C 102 EE 18
ETUF 25 14 C 102 EE 18
ETUF 28 14 C 102 EE 18
ETUF 32 14 C 102 EE 20
ETUF 36 14 C 102 EE 20
COnTRALATERAL ILIAC LIMBs
Proximal
Graft
Diameter
(mm)
Product Code
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
Total
Contralateral
Covered Length
with Bifurcated †
ETLW 16 10 C 82 EE 14 132
ETLW 16 10 C 93 EE 14 143
ETLW 16 10 C 124 EE 14 174
ETLW 16 10 C 156 EE 16 206
ETLW 16 10 C 199 EE 16 249
ETLW 16 13 C 82 EE 14 132
ETLW 16 13 C 93 EE 14 143
ETLW 16 13 C 124 EE 14 174
ETLW 16 13 C 156 EE 16 206
ETLW 16 13 C 199 EE 16 249
ETLW 16 16 C 82 EE 14 132
ETLW 16 16 C 93 EE 14 143
ETLW 16 16 C 124 EE 14 174
ETLW 16 16 C 156 EE 16 206
ETLW 16 16 C 199 EE 16 249
ETLW 16 20 C 82 EE 16 132
ETLW 16 20 C 93 EE 16 143
ETLW 16 20 C 124 EE 16 174
ETLW 16 20 C 156 EE 16 206
ETLW 16 20 C 199 EE 16 249
ETLW 16 24 C 82 EE 16 132
ETLW 16 24 C 93 EE 16 143
ETLW 16 24 C 124 EE 16 174
ETLW 16 24 C 156 EE 16 206
ETLW 16 24 C 199 EE 16 249
ETLW 16 28 C 82 EE 16 132
ETLW 16 28 C 93 EE 16 143
ETLW 16 28 C 124 EE 16 174
ETLW 16 28 C 156 EE 16 206
ETLW 16 28 C 199 EE 16 249
† Subtract total contralateral covered length of bifurcated by 10 mm
when using the 124 mm-length bifurcated stent graft.
AORTIC ExTEnsIOns
Proximal
Graft
Diameter
(mm)
Product Code
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETCF 23 23 C 49 EE 18
ETCF 25 25 C 49 EE 18
ETCF 28 28 C 49 EE 18
ETCF 32 32 C 49 EE 20
ETCF 36 36 C 49 EE 20
ABDOMInAL TUBEs
Proximal
Graft
Diameter
(mm)
Product Code
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETTF 23 23 C 70 EE 18
ETTF 25 25 C 70 EE 18
ETTF 28 28 C 70 EE 18
ETTF 32 32 C 70 EE 20
ETTF 36 36 C 70 EE 20