indications and intended use
The device is intended for injection by authorized medical personnel to:
- Provide mechanical restoration and reconstruction of soft tissue volume (volumetry of the cheeks, cheekbones, and facial oval).
- Correct severe volumetric deficits of the skin and subcutaneous tissue.
- Provide structural correction of the nose and chin shape.
- Provide symptomatic treatment of facial lipoatrophy, including in patients with the HIV virus (lipodystrophy syndrome).
Bi-Soft® Injection System The product is packaged in specialized Bi-Soft® syringes. The ergonomic design is characterized by precise balance and a non-slip grip surface, allowing the physician full control over the high injection force required when administering dense volumetric gel. This design minimizes the physical effort of the operator, increasing the stability of the preparation’s delivery into deep tissue layers.
treatment areas
- Cheekbones and cheeks.
- Facial contour and jawline.
- Temples.
- Chin and nasal bridge.
mechanism of action
Cross-linked sodium hyaluronate at a concentration of 26 mg/ml acts as a stable implant with a very high elastic modulus (G’ prime). The mechanism of action involves the physical filling of space and mechanical tissue support, resulting in an immediate volumetric effect. The estimated duration of the preparation is up to 12 months, depending on the degree of tissue deficit, injection technique, and the patient’s individual characteristics.
injection depth
- Deep dermis.
- Subcutaneous tissue (subcutaneous layer).
- Supraperiosteal (depending on the area).
composition
- Cross-linked Sodium Hyaluronate: 26 mg/ml.
- Mannitol: ancillary substance (antioxidant).
- Phosphate buffer pH 7.2 q.s. ad 1 ml.
contents
- 2 sterile pre-filled syringes (1 ml).
- 2 sterile 23G 1/4 needles.
- 2 sterile 27G 1/2 needles.
Reviews
There are no reviews yet.