2. Caution: The PHIL™ device is not cleared/approved by the U. S
Caution: The PHIL™ device is not cleared/approved by the U.S. FDA for sale or use in the United States.

3. PHIL™ Composition
PHIL™ is a liquid embolic agent made of a co-polymer dissolved in DMSO during the liquid phase and linked with an iodine agent for radiopacity purpose during injection
Non-adhesive co-polymer-based liquid embolic material
Hydroxyethyl methacrylate (PHEMA)
Radiopacity from Iodine contrast agent covalently bonded
Dissolved in DMSO solvent
Dimethyl Sulfoxide
Component 1
Component 2

4. Indications For Use (CE mark)
The PHIL device is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors

5. PHIL™ Copolymer Main Characteristics
Soluble in DMSO
Will solidify in an aqueous (Water) environment
Non-Thrombogenic
Shown per Pre-clinical testing
Non-exothermic
No chemical reaction as nBCA polymerization
Non-adhesive
Radiopaque
Cohesive

6. PHIL™ Mode of Action PHIL™ is delivered Upon contact with blood
In liquid phase
Through a DMSO compatible microcatheter
Upon contact with blood
Solvent (DMSO) diffuses away
PHIL precipitates in-situ
Precipitation / solidification begin immediately from the outside
The distance traveled before solidification depends on
Flow rate in the vessel
Position of the microcatheter in the malformation
Rate of injection
Viscosity (precipitating characteristics)
Liquid Phase
“Solid” PHIL
Cross section at 30 seconds
Cross section at 2 minutes

7. PHIL™ System Components
1cc of PHIL in pre-filled Sterile syringe
1cc of DMSO in pre-filled Sterile syringe
Catheter specific adapters
IFU
Talking Points:
The PHIL system contains 1 syringe of liquid embolic, 1 syringe of DMSO, and 3 catheter specific adapters (DUO, SCEPTER, and SONIC) each in its respective tyvek heat sealed pouch.
All components are sterilized with an autoclave procedure.
An IFU is provided in each PHIL System.
3 separate sterile pouches

8. PHIL™ overview
Catalog Number
Concentration
When to use
Volume of LE
Embolic capacity
Viscosity
LEN10250
PHIL 25%
Low flow scenarios
Distal access
1mL
0.85mL
16 cSt
LEN10300
PHIL 30%
Moderate flow scenarios
When feeding pedicle injections are conducted close to the nidus
0.87mL
36 cSt
LEN10350
PHIL 35%
Higher flow scenarios
Large fistulous components embolization
0.94mL
72 cSt
Concentration = percentage of embolic material in DMSO in weight
When to use = Factors that influence which concentration to use
Flow rate of the vascular lesion
Distal or proximal penetration desired
Position of the microcatheter
Volume of Liquid Embolic = DMSO + Copolymer bounded with iodine
Embolic Capacity = volume of embolus created by 1ml of embolic material
Viscosity = measure in centistokes (ex: water = 1cSt, Blood = 5cSt)

9. Key Features and benefits
Ready to use
No Shaking
Pre-filled syringes
Sterile set
Optimized visibility
Perfect homogeneity of radiopacity of Liquid embolic
Optimum visibility all along the procedure
Visibility of Microcatheter tip during the treatment
No metallic component
Minimize (streak) artefact during control imagery
No saturated radio-opaque cast to facilitate stages endovascular treatment
Compatible with surgical resection
No tattoo effect of the Tantalum powder in superficial malformations treatment
High embolic Capacity
Less DMSO injected
More Embolus created with 1mL of Embolic material