Archus公司治疗脊椎狭窄的移植物获得CE标签

一种获得的脊椎骨移植物被设计用于治疗脊椎狭窄，这是一种脊椎关节的退行性病变，导致脊髓神经的压缩，产生下肢的神经症状。

在传统上，脊椎狭窄的患者都接受减压椎板切除手术，而这常常并发脊柱融合。而这种新型移植物，叫做脊椎关节成型系统（TFAS），使用假体关节移植物替代退行性病变的脊椎关节，这就恢复了脊椎稳定性和正常的脊椎运动，免除了脊椎融合的需要。这种新型系统，是有Archus Orthopedics集团(Redmond,WA, USA)研制开发的，已经获得了CE标签。

Archus主席兼执行总裁Jim Fitzsimmons评价说：“CE标签对Archus公司而言是一个新的里程碑，是对这种重要的新型设备过去3年研制过程中严格的科研、设计、以及测试的合法确认。”

Fitzsimmons主席指出：此时公司不会在欧洲全力推广应用，“我们的最初的计划是与一些著名的中心采取细致的、探索性途径来积累这种设备的临床应用经验。”
 
Spinal Implant for Stenosis
 
A patented spinal implant is designed to treat spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves, producing neurologic symptoms in the legs.

Traditionally, patients with spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spine fusion. The new implant, called Total Facet Arthroplasty System (TFAS), replaces the degenerative facet joints with a prosthetic joint implant that restores stability and normal motion to the spine, eliminating the need for fusion. The new system, developed by Archus Orthopedics, Inc. (Redmond,WA, USA) has received the CE Mark.

“The CE Mark is a significant milestone for Archus and a clear validation of the rigorous research, design, and testing activities completed over the last three years to develop this important new device,” remarked Jim Fitzsimmons, chairman and CEO of Archus.

Chariman Fitzsimmons indicated that the company will not pursue a full-scale launch of the TFAS in Europe at this time. “Initially, our plan is to take a careful, investigational approach with a few prominent centers and accumulate clinical experience with the device.”