TriVascular Abdominal Stent Graft

Transcription

TriVascular
Abdominal Stent Graft
Introduction to Device and Case Planning
©2015 TriVascular, Inc. All Rights Reserved. Confidential. For Customer Use Only Caution: Federal (USA) law
restricts this device to sale by or on the order of a physician. 820-0027-01rC
• The TriVascular Abdominal Stent Graft
incorporates novel technology with a unique
approach to device planning
• As with all devices, proper device selection
greatly influences patient outcome
©2015 TriVascular, Inc. All Rights Reserved. Confidential. For Customer Use Only Caution: Federal (USA) law restricts this device
to sale by or on the order of a physician. 820-0027-01rC
Device Planning
2
Tri-modular design
14-15F OD main body
Low-viscosity,
radiopaque,
fill polymer
12-15F OD
conformable
iliac limbs
Suprarenal nitinol stent
with integral anchors for
fixation
Inflatable rings for
optimal seal
TriVascular Abdominal Stent Graft
3
IR+16
IR+13
IR+20
IR-35
IR
IR+45
IR+80
Diameters
Lengths
Sizing Considerations
4
Sizing Considerations
5
Aortic Body
Special Considerations
©2015 TriVascular, Inc. All Rights Reserved. Confidential. For Customer Use Only Caution: Federal (USA) law restricts this
device to sale by or on the order of a physician. 820-0027-01rC
• Proximal Sealing Zone
• Diameter
• Angulation
• Orientation
• Additional Landmarks
• Length (centerline)
• Flow Lumen
Special Considerations: Aortic
Body
7
1
35 mm 13 mm
2
1)
1 Select aortic body size based on
diameter at location of the Sealing Ring:
13 mm distal to inferior renal artery
(IR+13)
• Note characteristics of disease present
• Review diameters at IR+16 to aid in
device selection
2
Confirm suprarenal aortic diameter at
location of the Anchors 35mm proximal
to inferior renal artery (IR-35) does not
exceed the maximum allowable diameter
at that location for the chosen aortic body
size
Note reference points:
• Bottom edge of the inferior renal is “IR”
• “IR-” is proximal direction toward heart
• “IR+” is distal location away from the heart
Proximal Sealing Zone: Diameter
8
2
1
1
Proximal
Graft
Nominal
Size (mm)
Min – Max
Vessel
Diameter
(mm)
20
23
26
29
34
16 – 17
18 – 20
21 – 23
24 – 26
27 – 30
2
Max Aortic
Ovation
Ovation
Inner
®
Vessel
Labeled Prime
iXTM
“Bore”
Diameter at
Length Delivery Delivery
Diameter
(mm) Catheter Catheter
Anchors
(mm)
(mm)
OD (F) ID / OD (F)
24
26
29
32
35
15.1
17.2
19
22
26
80
80
80
80
80
14
14
14
14
15
12 / 14
12 / 14
12 / 14
12 / 14
13 / 15
Note: Standard rounding rules apply to vessel diameter measurements.
Indications are for proximal aortic neck inner wall diameter of no less than 16mm
and no greater than 30mm.
9
Seal is obtained when the gasket-like sealing ring conforms to the
inner vessel wall
Circumference of the sealing ring must exceed the circumference of
the inner vessel wall to achieve seal
Average of the minimum and maximum diameters is used as an
approximation of circumference to select the appropriate aortic body
Proximal Seal Zone: Diameter
Minimum and Maximum Averaging
10
Normal:
Measure flow lumen (inner diameter)
Obtain minimum and maximum diameters
Thrombus and Calcium:
Include 50% of thrombus (up to 2mm in any
direction)
Include half the thickness of the calcium
Oversizing:
Excessive oversizing may lead to narrowing
of the aortic flow lumen
Ballooning is often an effective means to
improve the lumen contour in irregular necks
or if luminal narrowing is observed
Thrombus Example
Calcification Example
11
A
A
A = Renal – 35mm
Measure angle on lesser curve
C
Angle limits apply between points AA and C
C
There is no angulation limit below point C
Angle indications:
B
B
C
B = Apex
C = Renal + 20mm
C
Proximal Sealing Zone: Angulation
Angle of ≤ 60 degrees if proximal neck is ≥ 10
mm
≤ 45 degrees if proximal neck is < 10 mm
12
Expected
Stent Axis
Orientation of the aortic body
will be determined by the
suprarenal stent
Important to align the axis in a
3D MPR view with the
expected stent axis.
This may result in
recommending a larger sized
aortic body to accommodate a
‘non-orthogonal’ sealing zone
Additional information for
angulated anatomy on following
slides
Inferior
Renal
Sealing Ring
@ IR+13
Proximal Sealing Zone: Angulation
and Graft Orientation
13
Significant Juxtarenal Angulation (>45o and ≤60o)
Sealing ring can flex 10deg relative to stent.
Model w/ 10o Adjustment when juxtarenal angle >45o and ≤60o
Expected
Stent Axis
2
Stent
3
Maximize
Angle
Collar
1
Inferior Renal
IR
1
1.
Find inferior renal (IR)
2.
2
Adjust 3D MPR axes so parallel to
flow lumen of stent (IR to IR-35)
3
3. Rotate to locate plane where
juxtarenal angle is maximized.
4. Translate IR +13mm to sealing
ring (orthogonal to stent axis)
5. Draw 10deg reference angle away
from lesser curve and rotate plane
so cross-section is more circular
6. Measure min x max for average
Proximal Sealing Zone:
14
Significant Juxtarenal Angulation (>45o and ≤60o)
Sealing ring can flex 10deg relative to stent.
Model w/ 10o Adjustment when juxtarenal angle >45o and ≤60o
Expected
Stent Axis
Stent
Maximize
Angle
5
10o Adjustment
4
Translate
IR+13
Collar
Inferior Renal
IR
Sealing Ring
@ IR+13 with
Adjustment
6
1
1.
Find inferior renal (IR)
2.
2
Adjust 3D MPR axes so parallel to flow
lumen of stent (IR to IR-35)
3
3. Rotate to locate plane where juxtarenal
angle is maximized.
4
4. Translate IR +13mm to sealing ring
(orthogonal to stent axis)
5
5. Draw 10deg reference angle away from
lesser curve and rotate plane so crosssection is more circular
6
6.
Measure min x max for average
10deg
rotation
IR+13 w/ 10deg
Proximal Sealing Zone:
15
45 mm
13 mm
80 mm
35 mm
• Evaluate flow Lumen at IR+45 and IR+80 to
determine the environment into which the
aortic body legs will open
• Influences orientation (A-P versus usual LAT)
• If lumen is ≤18mm, narrowing of one aortic
body leg may occur
• With very narrow flow lumens <14mm,
ensure bilateral wire access before
deployment of iliac limbs
• Note cannulation region at IR+80
• Minimum length from inferior renal to native
bifurcation > 80mm
• Confirm Length via centerline measurement
Additional Aortic Body Landmarks
16
Iliac limbs
Special Considerations
• Length (centerline)
• Diameter
• Use of Limbs as Extensions
Special Considerations: Iliac Limbs
18
Tapered Limb
*28mm limb diameter available with the Ovation iX™ Iliac Stent Graft
30mm
Sealing
Zone
30mm
Sealing
Zone
10-12mm
Flared Limb
20mm
Transition Zone
14-28*mm
30mm
Docking Zone
30mm
Docking Zone
Iliac Limb Zones
19
30 mm
When sizing the limbs,
include the 30mm
overlap in limb length
Universal docking zone:
All iliac limbs fit into all
aortic bodies
Distal
Graft
Nominal
Size
(mm)
Labeled Lengths*
10
80
100
120
140
160
12
80
100
120
140
160
14
80
100
120
140
160
16
80
100
120
140
160
18
80
100
120
140
160
22
80
100
120
140
160
28
80
100
120
140
160
Total
Stent
Graft
Length
130
150
170
190
210
Iliac Limb: Length Selection
20
* 28mm diameter and 160 limb length available with the Ovation iX™ Iliac Stent Graft
Centerline Measurements
• Planning for the iliac limbs is similar to planning
for other iliac devices.
• Please note that TriVascular’s limbs are highly
conformable to anatomy and typically follow
centerline measurements
Calcium
Calcification Example
• Include half the thickness of the calcium
Thrombus / Atheroma
• Measure to the “true” lumen (include 100%
thickness of the thrombus / atheroma)
Oversizing
• Additional oversizing of the iliac limb may be
beneficial in irregular lumens
Thrombus + Calcium
Iliac Limb: Diameter Sizing
21
Distal Graft
Nominal Size
(mm)
Native Iliac
Vessel ID
Range (mm)
Min – Max
Vessel
Diameter
(mm)
Ovation
Prime®
Delivery
Catheter OD
(F)
Ovation iX
Delivery
Catheter
ID / OD (F)
10
8-9
8-9
13
10 / 12
12
10-11
10-11
13
10 / 12
14
12-13
12-13
13
10 / 12
16
14-15
14-15
14
11/13
18
16-17
16-17
14
11/13
22
18-20
18-20
15
12/14
281
21-25
21-25
--
13/15
Note: Standard rounding rules apply to vessel diameter measurements.
Indications are for inner wall diameter of no less than 8mm and no
greater than 25mm2.
128mm
limb diameter available with the Ovation iX™ Iliac Stent Graft
iX™ Iliac Stent Graft allows treatment up to 25mm iliac vessel
2Ovation
Iliac Limb: Diameter Sizing
22
All Iliac Limbs may be used as extensions
Iliac Limb Distal
Diameter (mm)
10
12
14
16
18
22
281
*Diameter
Amount of Extension
Required (mm)
Extension Component
Length (mm)
Up to 50 mm
80
51 – 70
100
71 – 90
120
91 – 110
140
111-130
1602
Up to 10*
80*
11 – 20
100
21 – 40
120
41 – 60
140
61 – 80
1602
Iliac Limbs: As Extensions
of extension must be ≥ distal diameter of iliac limb
23
128mm
2160
limb length available with the Ovation iX™ Iliac Stent Graft
10
12
14
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
24
Iliac Limb Extension Sizes
Labeled
Diameter
(mm)
Length
(mm)
Native Iliac
ID (mm)
Ovation
Prime
Delivery
Catheter
OD (F)
Ovation iX
Delivery
Catheter
ID / OD (F)
10
45
8–9
13
10/12
12
45
10 – 11
13
10/12
14
45
12 – 13
13
10/12
16
45
14 – 15
13
11/13
18
45
16 – 17
14
11/13
22
45
18 - 20
14
12/14
281
45
21 - 25
--
13/15
45 mm
10-281 mm
Iliac Limb Extension (45mm)
10
12
Key Points:
• Use Iliac Limb Extensions for 20 mm
or less of required extension length
• Iliac Limb Extension size is the
labeled diameter
128mm
14
16
18
22
281
16
18
22
281
Measurement and Device
Planning Worksheet
Device Planning Worksheet
26
Include percentages of thrombus and calcium when
measuring diameters as shown below.
Reference points:
Bottom edge of the inferior renal is “IR”
“IR-” is proximal direction toward heart
“IR+” is distal location away from the heart
Location
Anchorage
Sealing
IR-35
IR+13, +16
Additional
Landmarks
Iliacs
IR+45, +80,
Native Bifurcation
Iliacs
Lumen
True Lumen
For Sealing
Thrombus
100%
Include 50%
of thrombus
(up to 2mm in
any direction)
Calcium
50%
50%
Flow Lumen
0%
0%
True Lumen
100%
50%
Diameter Measurement Guidelines
27
• Landmarks (Inferior Renal)
• Angulation
• Juxtarenal (lesser curve)
• Infrarenal (if significant)
• Aortic Diameter
• IR-35mm
• IR
• Maximum of IR+13mm & IR+16mm
• IR+45mm
• IR+80mm
• Native Bifurcation
• Iliac Diameters & Lengths
• Maximum of Distal Diameters
• Iliac Lengths (centerline)
• IR to Native Bifurcation Length
• IR to Internal Iliac Artery Lengths
• Access
Sizing Considerations Summary
28
Access
• Narrow access < 4.7mm
advance delivery system, pre-dilate if resistance is encountered
Aortic Body
• Significant Angulation
retract guidewire, avoid tension, confirm seal, balloon if needed
• Calcium and thrombus
confirm seal, balloon if needed
• Flow lumen diameter
cannulation considerations, post limb ballooning if needed
Iliac Limbs
• Lengths
marker catheter confirmation
• Calcium and thrombus
post limb ballooning if needed
• Narrow flow lumen
post limb ballooning if needed
• Narrow aortic bifurcation < 18mm
recommend kissing balloons post limb deployment
Additional Considerations
29
INDICATIONS FOR USE: The TriVascular Ovation iX™ Abdominal Stent Graft System is indicated for treatment of patients with abdominal aortic aneurysms having the
vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or
percutaneous), devices, and/or accessories; proximal aortic landing zone: with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below
the inferior renal artery, and with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm; distal iliac landing zone: with a
length of at least 10 mm, and with an inner wall diameter of no less than 8 mm and no greater than 25 mm.
CONTRAINDICATIONS: The system is contraindicated for use in patients who have a condition that threatens to infect the graft and in patients with known sensitivities or
allergies to the device materials (including polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, fluorinated ethylene propylene [FEP] or nitinol). Also
consider the information in Section 4 Warnings and Precautions of the systems’ Instructions for Use.
Refer to Instructions for Use at TriVascular.com for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
NOTE: Not all product components are available in every country. Please consult with your TriVascular representative to confirm product availability.
CE marked. Please refer to current product instructions for use.
©2015 TriVascular, Inc.
to sale by or on the order of a physician. 820-0027-01rB
CAUTION: The information provided is based on anonymized patient data submitted to TriVascular by a clinician(s) familiar with the patient and with the use of the
TriVascular Abdominal Stent Graft System. The information is provided by TriVascular representatives who are not medical practitioners and who do not have medical
training. It remains, at all times, the responsibility of the clinician(s) to make an independent assessment of the patient’s anatomy and measurements and to make the
decision to proceed using the provided information either in whole, in part or not at all.
30

TriVascular Abdominal Stent Graft

Transcription

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