Caution: The PHIL™ device is not cleared/approved by the U. S

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Presentation transcript:

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.

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

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

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

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

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

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)

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