AUSTIN, Texas, Nov. 30, 2023 /PRNewswire/ -- Alafair Biosciences announced today that VersaWrap has received 510(k) clearance from the FDA, enabling application of VersaWrap in all populations, regardless of age. The additional clearance allows pediatric surgeons and facilities the flexibility to use VersaWrap in treating younger populations.

2023年11月30日，德克萨斯州奥斯汀/PRNewswire/-Alafair Biosciences今天宣布VersaWrap已获得FDA 510（k）许可，可在所有人群中应用VersaWrap，无论年龄大小。额外的间隙允许儿科外科医生和设施灵活地使用VersaWrap治疗年轻人群。

VersaWrap, a class II medical device, is a bioresorbable hydrogel implant that forms a gelatinous layer around target tissues such as tendons, peripheral nerve and surrounding soft tissues, allowing gliding during healing and reducing postoperative tethering to give consistent results. VersaWrap may be implanted as a sheet or as a gel and is used primarily by orthopedic, reconstructive plastic, and spine surgeons in a wide variety of tendon and peripheral nerve procedures..

VersaWrap是一种II类医疗器械，是一种生物可吸收的水凝胶植入物，可在肌腱，周围神经和周围软组织等靶组织周围形成凝胶状层，可在愈合过程中滑动并减少术后束缚，从而获得一致的结果。VersaWrap可以作为片材或凝胶植入，主要由整形外科，重建塑料和脊柱外科医生用于各种肌腱和周围神经手术。。

This clearance is another milestone reached in the Alafair Biosciences mission to provide tools to surgeons that improve patient outcomes related to unwanted postoperative tethering. Alafair continues to expand its portfolio of indications for use and populations that it serves.

这一清除是ALAFIR生物科学使命中达到的另一个里程碑，旨在为外科医生提供工具，以改善与不必要的术后束缚相关的患者预后。Alafair继续扩大其使用适应症和服务人群的组合。