May be used with
PHIL™ The Difference
Free From Preparation and Tantalum Constraints
Key Clinical Benefits:
What is PHIL ? ™
The PHIL™ System is a non-adhesive liquid
embolic agent comprised of a biocompatible
polymer dissolved in dimethyl sulfoxide (DMSO)
solvent. An Iodine component is covalently
bonded to the polymer to provide homogeneous 1 READY TO USE DEVICE
fluoroscopic visualization.
The PHIL™ Liquid Embolic is intended Pre-filled sterile syringes
for use in the embolization of lesions in – No preparation required
the peripheral and neurovasculature, – No risk of contamination and needle stick injury
including arteriovenous malformations
– High embolic capacity loaded in a 1mL syringe
and hypervascular tumors.
(See Embolic Capacity Chart on flap)
Scepter balloon catheter
inflation in the Middle
Meningeal Artery
PHIL™ Competitor A
homogeneous (dark Line)
radiopacity
PHIL™
Scepter distal tip
in PHIL™ cast
Figure 1 Figure 2
Tentorial AVF treated with PHIL™ and Competitor A Liquid Coronal CT Reconstruction of Posterior Fossa AVM.
Embolic injection through Scepter balloon catheter.
Images courtesy of Dr. Naci Kocer, Istanbul University, Cerrahpasa Medical Faculty, Istanbul, Turkey.
2 Optimized Visibility
Iodine component is covalently bonded to the co-polymer
– No shaking needed
– Perfect homogeneity of PHIL™ radiopacity (Figure 1)
– Same visibility regardless the procedure length
Lower density of radiopacity
– Perfect balance between visibility and cast masking effect
– Visibility of microcatheter tip during treatment (Figure 1)
3 NO METALLIC COMPONENTS
No risk of microcatheter blockage due to
Tantalum aggregation
Minimize (streak) artifact during control imaging (Figure 2)
– Facilitate staged procedures or combined treatments
Compatible with surgical resection
– No hazard related to sparking/combustion
No tattoo effect seen in superficial malformation treatment
EMBOLIC CAPACITY
mL’s of Precipitate Volume per mL of Liquid Embolic
1.00
0.90
0.80
Precipitate Volume (mL)
0.70
0.60
0.50
0.40
0.30
0.20
0.10
0.00
Competitor A PHIL™ 25% PHIL™ 30% PHIL™ 35%
PHIL™ vs. Competitor A
(similar viscosity to PHIL™ 25%)
Embolic Capacity Comparison
Precipitate Volume in
Product 1mL of Liquid Embolic
Competitor A • 0.67 mL
PHIL™ 25% • 0.85 mL
1 mL of PHIL™ 25% = 1.26 mL of Competitor A
PHIL™ 30% • 0.87 mL
1 mL of PHIL™ 30% = 1.3 mL of Competitor A
PHIL™ 35% • 0.90 mL
1 mL of PHIL™ 35% = 1.4 mL of Competitor A
Cross section at
30 seconds
Precipitate dissected after soaking
in 37°C Phosphate Buffered Saline (PBS)
Cross section at
2 minutes
CASE STUDY
Transosseous
Arteriovenous
Malformation/Fistula
Late phase of DSA
Arteriovenous shunt fed via ophthalmic artery
Unsubstracted Image
After complete occlusion of the vascular lesion
with PHIL™ 25% via transvenous access
DSA : arterial and venous phase
No remaining vascular pathology after
PHIL™ injection
MIP from Dyna CT:
sagittal images from lateral to midline
Distribution of PHIL™ after end of procedure
Images courtesy of Dr. Markus Holtmannspötter
University of Copenhagen
Rigshospitalet, Denmark
PHIL™
Formulations
Product Code Concentration Viscosity Volume of LE When to Use
– Low flow scenarios
LEN10250 PHIL™ 25% 16cSt 1mL
– Distal access
– Moderate flow scenarios
LEN10300 PHIL™ 30% 36cSt 1mL – When feeding pedicle injections
are conducted close to the nidus
– Higher flow scenarios
LEN10350 PHIL™ 35% 72cSt 1mL – Large fistulous components
embolization
MICROCATHETER COMPATIBILITY Concentration:
Percentage of embolic material in DMSO in weight
PHIL must be used with DMSO compatible catheters such as:
™
Viscosity:
Dead Dead Space Measure in centistokes (ex: water = 1cSt, Blood = 5cSt)
Product Name Description Space with PHIL™ Adaptor
(mL) (mL) Volume of Liquid Embolic:
Compliant DMSO + Copolymer bounded with iodine
Scepter C ®
Occlusion Balloon 0.44 0.23
X-tra Compliant
Scepter XC® Occlusion Balloon 0.44 0.23
Headway® 17
Headway® 17 Microcatheter 0.41 0.26
Headway® Duo Headway® Duo 0.34 0.24
156cm Microcatheter
Headway® Duo Headway® Duo 0.35 0.25
167cm Microcatheter
PHIL™ System components
1mL of PHIL™ system in pre-filled
sterile syringe
1mL of DMSO in pre-filled sterile syringe
Catheter specific adaptors
Instructions for Use
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MICROVENTION, Headway, Scepter C and Scepter XC are a registered trademarks of MicroVention, Inc. PHIL is a trademark of MicroVention.
• Scientific and clinical data related to this document are on file at MicroVention, Inc. Refer to Instructions for Use, contraindications and
warnings for additional information. ©2015 MicroVention, Inc. MM412(i) 6/15