Teosyal Ultra Deep Puresense 2 x 1.2ml

TEOSYAL® PureSense ULTRA DEEP is a sterile, transparent, non-pyrogenic, viscoelastic gel made of hyaluronic acid (HA) of non-animal origin and of mean molecular weight higher than 1 million Dalton. It is crosslinked with BDDE (1,4-Butanediol diglycidyl ether), and contains 0.3% by mass of lidocaine hydrochloride, for its anesthetic properties. Each box contains two pre-filled syringes of TEOSYAL® PureSense ULTRA DEEP. For each syringe, the box contains two sterile 25G1” needles and two traceability labels (one to be given to the patient, and one to be kept by the doctor in the patient medical records). The volume of gel in each syringe is indicated on the cardboard box as well on each syringe.

Hyaluronic acid is a major constituent of the ground substance of the dermal extracellular matrix. A genuine molecular sponge, its helicoidal structure enables it to trap up to a thousand times its weight in water. It is widely distributed in cutaneous tissue and hydrates the skin, though its content diminishes with age. As the skin becomes thinner and fragile, initial skin fracture lines appear. TEOSYAL® PureSense ULTRA DEEP creates a volume that corrects wrinkles or facial contours and restores skin hydration.

TEOSYAL® PureSense ULTRA DEEP is a biodegradable implant that is progressively resorbed over time. The estimated lifetime of TEOSYAL® PureSense ULTRA DEEP is between 15 and 18 months. The duration of the treatment depends on several factors including skin type, the severity of the wrinkle to be treated, the injection area, the volume injected, the patient’s physiology and lifestyle. The injector will decide if a touch-up session may be required for optimal results.

In their aesthetic indications, TEOSYAL® products do not have an intended medical purpose. Therefore, the non-medical benefit of TEOSYAL® devices is understood as clinical performance. Overall, 70 to 100% of patients experienced an aesthetic improvement of the treated area following the injection, based on data collected throughout clinical studies program. In their medical indications, the clinical benefit of TEOSYAL® products is based on patient-reported outcomes measuring satisfaction and well-being following the treatment. Over clinical trials evaluating these indications, patient satisfaction rates were consistently higher than 70% up to six months after the first injection.