A Single-Stage Hyaluronic Acid Matrix for Cartilage Repair
Hyalofast® is a biodegradable, non-woven scaffold composed of HYAFF® (benzyl ester of hyaluronic acid) intended as support for the entrapment of mesenchymal stem cells (MSC) for the repair of chondral and osteochondral lesions. It acts as a support for bone marrow aspirate (BMA), bone marrow aspirate concentrate (BMAC), or as a chondroprotective coverage which favors in situ residence of mesenchymal stem cells after their mobilization following bone marrow stimulation procedures.
Hyalofast fibers favor cell adhesion, allowing MSC arrangement inside the three-dimensional matrix. Once implanted, it fills the defect and temporarily substitutes the chondral and osteochondral tissue in the lesion until it is absorbed and replaced by the cartilage tissue. As the HYAFF fibers degrade, the polymer releases the parent molecule enriching the implantation site with hyaluronic acid, a naturally occurring extracellular matrix molecule and a major component of human cartilage.
The unique handling properties of Hyalofast make it quickly and easily implantable via arthroscopy or mini-arthrotomy. The soft texture allows it to conform easily to the lesion anatomy. It readily adheres to the site of application without requiring additional fixation in most cases. The scaffold can be applied in any orientation or stacked due to its uniform single-layer 3D structure.
Hyalofast has been clinically demonstrated to be safe and effective in medium-to-long-term follow-up of 8 years in the repair of ankle, knee or hip chondral and osteochondral lesions, permitting the filling of the lesion with a high volume of new hyaline-like cartilage tissue, and smooth integration with the surrounding cartilage. Patients reported reduction in pain and good functional improvement of the affected injured joint, thus enabling return to their daily/non-impact sport activities with substantial pain relief and high satisfaction.
Key Features & Benefits:
- Single-stage, off-the-shelf cartilage repair procedure
- Versatile: acts as a scaffold for bone marrow aspirate or as a chondroprotective coverage after bone marrow stimulation procedures; usable either in open or minimally invasive surgery
- Fast: can be used with or without fixation means; easily adaptable to any lesion shape
- Two available sizes allow different lesion sizes to be easily covered: 2×2 cm and 5×5 cm
- Clinically demonstrated to be safe and effective up to medium-long-term follow-up of 8 years
Anika is currently enrolling patients in a U.S. clinical trial for Hyalofast.
Hyalofast is not approved for use in the United States.
Hyalofast is CE-marked indicated for the repair of chondral and osteochondral lesions.
Anika products may not be available in all geographies. Product availability is subject to the regulatory clearances in individual markets. Please reach out to your local representative or Contact Us if you have questions about specific market approvals.
For complete product information, including indications, contraindications, warnings, and precautions, please refer to the Instructions for Use provided with the product or Contact Us for a copy.
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