Technical Information
HYALOFAST® is a white non-woven pad entirely composed of HYAFF®, a semi-synthetic derivative of hyaluronic acid, a naturally occurring extracellular matrix molecule and a major component of human cartilage. After spontaneous degradation following application, the polymer releases the parent molecule enriching the transplantation site with hyaluronic acid.
HYALOFAST® is a biodegradable support for the entrapment of mesenchymal stem cells for the repair of chondral or osteochondral lesions.
HYALOFAST® acts as a support for bone marrow aspirate or as a chondroprotective coverage which favors in situ residence of mesenchymal stem cells after their mobilization due to microfracture or perforation procedures.
HYALOFAST® is initially filling the defect and temporarily substituting the chondral and osteochondral tissue in the lesions until it is absorbed and replaced by the skeletal tissue.
INDICATIONS FOR USE
Repair of chondral or osteochondral lesions.
REGULATORY STATUS
CE marked Medical device – Class III (Directive 93/42/EEC).
HOW SUPPLIED
Double packaging containing 1 non-woven pad (2×2 cm or 5×5 cm), suitable for operating theatre.
SHELF-LIFE
3 years from manufacturing date.
STERILITY
HYALOFAST is sterilized by gamma-radiation.
TRANSPORTATION AND STORAGE
Keep in a cool and dry place (T ≤ 40°C).
MANUFACTURER
Anika Therapeutics S.r.l.
Corso Stati Uniti 4/U
35127 Padova – Italy