Vericel Gains FDA Approval for Arthroscopic Delivery of MACI in Knee Cartilage Treatments
Vericel Gains FDA Approval for Arthroscopic Delivery of MACI in Knee Cartilage Treatments
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) expanding the MACI (autologous cultured chondrocytes on porcine collagen membrane) 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.
Vericel公司（纳斯达克：VCEL）是体育医学和严重烧伤护理市场先进疗法领域的领导者，今日宣布，美国食品药品监督管理局（FDA）已批准补充生物制品许可申请（sBLA），扩大了MACI（自体培养软骨细胞植入猪胶原膜）的适用范围，包括关节镜下给予MACI，用于修复膝部症状性单个或多个全层软骨缺损，最大面积达4平方厘米。MACI ArthroTm相较目前的方法，提供了一种更为微创的技术，使外科医生能够评估和准备缺损部位，并通过小切口使用专门设计的MACI Arthro器械植入MACI。