caution: the phil™ device is not cleared/approved by the u.s. fda for sale or use in the united...
TRANSCRIPT
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