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Vericel宣布FDA批准MACI Arthro上市
2024-08-26 19:54
- Vericel (NASDAQ:VCEL) has announced that the U.S. FDA has approved a supplemental Biologics License Application expanding the MACI® label to include arthroscopic delivery of MACI to repair symptomatic single or multiple full-thickness cartilage defects of the knee up to 4 cm2 in size.
- MACI ArthroTM provides a less invasive technique compared to the current approach, allowing surgeons to evaluate and prepare the defect site as well as deliver the MACI implant through small incisions using custom-designed MACI Arthro instruments.
- MACI is the first FDA-approved cellularized scaffold product that applies tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient's own knee.
- “The approval of MACI Arthro represents another significant milestone in our strategy to provide innovative solutions for patients suffering from pain and dysfunction caused by cartilage defects in the knee,” said Nick Colangelo, President and CEO of Vericel.
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