RTI公司推出异种移植物的介入螺丝钉

一种新型介入螺丝钉被设计用于关节内窥镜或者开放式前十字韧带（ACL）和/或者后十字韧带（PCL）重建手术。这种产品已经获得了美国食品药品管理的批准。

Sterling介入螺丝钉的长期吸收速度确保了在愈合期间的安全移植固定，其牵拉力量与金属介入螺丝钉相当。美国Regeneration Technologies公司(RTI, Alachua, FL, USA; www.rtix.com)研制开发了这种产品，这种移植物使用了RT获得保护的BioCleanse组织消毒程序。这就确保了异种移植物无菌，生物兼容性改善，并保留了组织结构的完整性。

RTI公司主席Brian K. Hutchison指出：“我们有能力研制开发新型移植物，并对异种移植物进行安全处理和消毒，对外科手术不能满足的需要提供生物解决方案。”

在2002年，该公司资助了一项动物实验，研究BioCleanse对异种移植物的作用。研究结果显示：BioCleanse处理程序对牛异种移植物性质的影响与同种移植物介入螺丝钉相同。RTI拥有BioCleanse的，该公司指出这是唯一得到证实的消毒程序，能够消灭组织中的病毒、细菌、真菌和孢子而不会影响组织的生物力学完整性。迄今为止，RTI已经销售了超过600000份使用BioClease消毒程序处理的同种移植物，感染率为零。

Xenograft Interference Screw
 
A new interference screw is designed for use in arthroscopic or open anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction. The device has been cleared by the U.S. Food and Drug Administration (FDA).

The Sterling interference screw has a long-term absorption rate, which ensures secure graft fixation throughout the healing process, and pullout strength is comparable to metal interference screws. Developed by Regeneration Technologies, Inc. (RTI, Alachua, FL, USA; www.rtix.com), the implant offers the benefits of RTI’s patented BioCleanse tissue sterilization process. This enables delivery of xenograft implants that are sterile and have improved biocompatibility and preserved structural integrity.

“We have the opportunity to capitalize on our competencies to develop new implants and to safely process and sterilize xenograft tissue to supplement the unmet demand for biological solutions in surgery,” observed Brian K. Hutchison, chairman of RTI.

In 2002, the company sponsored an animal study of the effects of BioCleanse on xenograft tissue. The results showed that the BioCleanse treatment process renders bovine xenograft essentially equivalent to an allograft interference screw. RTI holds the patents on BioCleanse, which the company notes is the only proven tissue sterilization process validated to eliminate viruses, bacteria, fungi, and spores from tissue without affecting the structural or biomechanical integrity of the tissue. To date, RTI has distributed more than 600,000 allograft implants sterilized with the BioCleanse process, with zero incidence of infection.