IN.PACT Amphirion
The Power of Clinical Research
Technical
Specifications
Leipzig Park-Hospital experience with DEB
in long BtK lesions
• Overall restenosis rate was reduced by 61%
• Restenosis of whole segment was reduced by 82%
80
Restenosis rate (%)
3 months restenosis rate (%)
70
Prior intervention
60
50
40
-61%
56
30
10
20
10
Catheter design Over the Wire (OTW)
FLEXITEC™ Ultra
Balloon material Balloon coating FreePac™- Paclitaxel eluting formulation
120 and 150cm*
Usable shaft lengths Shaft diameter proximal 3.3F for 120 cm shaft length
3.9F for 150 cm shaft length
middle 3.3F
distal 2.8F
Introducer sheath compatibility 4F
Guiding catheter compatibility
5F ( I.D. >0.056“)
0.014"
Max. recommended guidewire Nominal pressure
7 bar
IN.PACT Amphirion
paclitaxel-eluting PTA Balloon Catheter 0.014"
Restenosis Prevention
A Short-Term Therapy for
Long-Term Success in
Infrapopliteal Interventions
17
13
0
IN.PACT Amphirion
non focal
Post intervention
focal
Order
Information
IN.PACT Amphirion showed 27% restenosis after
3 months. Only 10% of patients had restenosis
of the whole segment while 17% had focal
restenosis. This result is dramatically different
from the historical control group where restenosis
typically appeared in the whole segment.
3 month fu
Dr. Schmidt LINC 2011
case example: courtesy of Dr. Schmidt, Leipzig
The IN.PACT clinical study program (BtK)
Currently (Feb 2011), 4 different INPACT studies are enrolling or
completed to investigate the effect of DEB in BtK/infrapopliteal
applications:
Study
No. of
patients
District
/
Indication
Type
1° Endpoint
IN.PACT DEEP
357
BTK / de-novo +
restenotic (no ISR)
RCT EU multicenter:
DEB vs PTA in CLI
12m LLL
12m TLR
IN.PACT BTK
Registry Leipzig *
104
BTK / de-novo +
restenotic (no ISR)
Single-arm single center
Registry in CLI +
severe claudication
3m Angio
Rest. Rate
IN.PACT BTK IT
Registry *
100
BTK / de-novo +
restenotic (no ISR)
Single-arm multicenter
Registry in Claudicants +
Rest Pain
6m Rest. Rate
IN.PACT BTK
Registry Abano
Terme*
122
BTK / de-novo +
restenotic (no ISR)
Single-arm single center
Registry in CLI
6m Rest. Rate
* investigator sponsored trial
Ref. N°
120 cm
shaft length
Ref. N°
150 cm
shaft length
Balloon Ø
(mm)
Markers
RBP
(bar)
AMD 020 040 00P
AMD 020 040 15P
2.00
40
2
15
AMD 020 080 00P
AMD 020 080 15P
2.00
80
2
14
AMD 020 120 00P
AMD 020 120 15P
2.00
120
2
14
AMD 025 040 00P
AMD 025 040 15P
2.50
40
2
16
AMD 025 080 00P
AMD 025 080 15P
2.50
80
2
15
AMD 025 120 00P
AMD 025 120 15P
2.50
120
2
14
AMD 030 040 00P
AMD 030 040 15P
3.00
40
2
16
AMD 030 080 00P
AMD 030 080 15P
3.00
80
2
15
AMD 030 120 00P
AMD 030 120 15P
3.00
120
2
14
AMD 035 040 00P
AMD 035 040 15P
3.50
40
2
16
AMD 035 080 00P
AMD 035 080 15P
3.50
80
2
15
AMD 035 120 00P
AMD 035 120 15P
3.50
120
2
14
AMD 040 040 00P
AMD 040 040 15P
4.00
40
2
16
AMD 040 080 00P
AMD 040 080 15P
4.00
80
2
15
AMD 040 120 00P
AMD 040 120 15P
4.00
120
2
14
www.medtronic.com
www.invatec.com
Global Headquarters
Hungerbüelstrasse 12
8500 Frauenfeld – Switzerland
Balloon
length (mm)
Usable shaft length
Balloon inflation port
Guidewire port
Kink protection
Balloon length
Balloon diameter
©2011 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170583, 02/11
non coated balloon*
*historical control
W elco m e to
Peripheral
Power.
TO INNOVATE
TO COLLABORATE
TO TREAT
IN_AMD_0170583_030311.indd 1
Innovating for life.
03.03.11 09:36
IN.PACT Amphirion
The Power of Results 1, 2
The Power of Lesion Specific Solutions
Next generation FreePac coating demonstrates excellent performance.
Designed specifically for lower extremity treatments
Paclitaxel-eluting pTA Balloon Catheter 0.014"
FreePac urea-based coating shows equivalent performance compared with
Ac/Matrix coating.
• BtK de novo and restenotic lesions
The Power of Optimized Drug Delivery
Development of stenosis due to neointimal proliferation in porcine coronary
arteries four weeks after stent implantation; overstretch about 1: 1.2,
randomized comparison of 3 treatments:
Broad array of diameters and lengths
• Specifically designed for BtK arteries
How IN.PACT DEBs work
The proprietary FreePac™ urea-paclitaxel coating on IN.PACT
DEBs optimizes drug delivery:
Proven Amphirion Deep Balloon Platform
Control n=14, Ac/Matrix n=12, FreePac n=12
• FLEXITEC™ Ultra balloon material
Percent stenosis (angiography); negative values
indicate persistent over-dilatation
• 4F compatible for all sizes
• The IN.PACT DEB is delivered to the lesion using state of the art peripheral balloon catheters
• Low profile
• As the balloon unwraps, the FreePac coating is fully exposed and presented
to the vessel wall
• Urea molecules in the coating separate and free the paclitaxel molecules, increasing their solubility and facilitating their absorption into the artery
Balloon Lengths
40mm
80mm
% stenosis
• Kink resistant shaft material
120mm
Ac/Matrix coating
IN.PACT FreePac Matrix
• Rapid, short-term drug delivery within 30–60 seconds
• Continued antirestenotic protection as paclitaxel stays in the arterial wall for at least 28 days
Paclitaxel is carried across the
vessel wall by the urea
Balloon Diameters 2.0, 2.5, 3.0, 3.5, 4.0mm
2.0
2.5
3.0
3.5
minimal lumen diameter (mm)
• Increased drug solubility and optimal diffusion into the vessel wall
Urea “Separator“ Molecule
27
Control
-7
-14
Ac/Matix
FreePac
FreePac and Ac/Matrix vs. Control each p < 0.001; FreePac
vs. Ac/Matrix p = 0.25
By over-dilatation the lumen in all treated vessel segments
was increased by 15-20% over the reference diameter
resulting in a corresponding negative ‘diameter-stenosis’.
Excessive neointimal proliferation reduces the lumen
diameter in the control group (no paclitaxel) not only to
the reference diameter but to a 27% stenosis, whereas
the original enlarged diameter of the treated segments
remain almost unchanged if treated with the paclitaxelcoated balloons with no difference between the Ac/Matrix
and FreePac coating.
Minimal lumen diameter (angiography)
IN.PACT’s unique FreePac coating combines urea and paclitaxel molecules
into a single compound that provides:
Paclitaxel Molecule
60.0
50.0
40.0
30.0
20.0
10.0
0.0
-10.0
-20.0
-30.0
-40.0
3.5
3.0
2.5
2.68
2,72
Ac/Matix
FreePac
2.0
1.5
1.0
1.44
FreePac and Ac/Matrix vs. Control each p < 0.001; FreePac
vs. Ac/Matrix p = 0.68
Significantly larger lumen diameter in paclitaxeltreated arteries than in the control group and no
difference between the Ac/Matrix and FreePac coating.
0.5
0.0
4.0
Control
Neointimal area (histology)
8.0
neointimal area (mm2)
Control
I N . P A C T P aclita x el el u tion ti m eline
The FreePac coating
ensures that drug delivery occurs within
30–60 seconds.
Paclitaxel’s ongoing retention in the medial
layer provides continual antirestenotic
protection to the target site.
wrapped Balloon
The IN.PACT DEB is
delivered to the target site
IN_AMD_0170583_030311.indd 2
folds unwrapping
The balloon unwraps to
expose the FreePac coating
balloon inflated and eluting
Urea molecules facilitate carriage of pacli­
taxel molecules across the vessel wall
10 seconds
15 seconds
elution
Drug elution takes place
within 30 - 60 seconds
6.0
5.0
5.78
4.0
3.0
2.0
2.86
2,75
Ac/Matix
FreePac
FreePac and Ac/Matrix vs. Control each p < 0.001; FreePac
vs. Ac/Matrix p = 0.82.
Significantly less neointimal proliferation in paclitaxeltreated arteries and no difference between the Ac/
Matrix and FreePac coating.
1.0
0.0
Control
Literature:
1 Paclitaxel-coated balloons - Survey of preclinical data.
Schnorr B, Kelsch B, Cremers B, Clever YP, Speck U, Scheller B.
Minerva Cardioangiol 2010;58:567-82
2 Dose Response to Paclitaxel-Coated Balloon Catheters in the Porcine Coronary Overstretch
and Stent Implantation Model.
Kelsch B, Scheller B, Biedermann M, Clever YP, Schaffner S, Mahnkopf D, Speck U, Cremers B
Invest Radiol 2011;46: 255-263
DRUG UPTAKE
COMPLETED
60 seconds
7.0
28 days
03.03.11 09:36