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

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

in the United States.

• 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

PHIL™ Composition

Component 1

Component 2

The PHIL device is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors

Indications For Use (CE mark)

PHIL™ Copolymer Main Characteristics

• PHIL™ copolymer

– 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

• PHIL™ is delivered– 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)

PHIL™ Mode of Action

Liquid Phase

“Solid” PHIL

Cross section at 30 seconds

Cross section at 2 minutes

PHIL™ System Components

• 1cc of PHIL in pre-filled Sterile syringe

• 1cc of DMSO in pre-filled Sterile syringe

• Catheter specific adapters

IFU

3 separate sterile pouches

PHIL™ overview

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)

Catalog Number

Concentration When to useVolume 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

1mL 0.87mL 36 cSt

LEN10350 PHIL 35% • Higher flow scenarios• Large fistulous components

embolization

1mL 0.94mL 72 cSt

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