一種獲得的脊椎骨移植物被設(shè)計(jì)用于治療脊椎狹窄，這是一種脊椎關(guān)節(jié)的退行性病變，導(dǎo)致脊髓神經(jīng)的壓縮，產(chǎn)生下肢的神經(jīng)癥狀。

在傳統(tǒng)上，脊椎狹窄的患者都接受減壓椎板切除手術(shù)，而這常常并發(fā)脊柱融合。而這種新型移植物，叫做脊椎關(guān)節(jié)成型系統(tǒng)（TFAS），使用假體關(guān)節(jié)移植物替代退行性病變的脊椎關(guān)節(jié)，這就恢復(fù)了脊椎穩(wěn)定性和正常的脊椎運(yùn)動(dòng)，免除了脊椎融合的需要。這種新型系統(tǒng)，是有Archus Orthopedics集團(tuán)(Redmond,WA, USA)研制開(kāi)發(fā)的，已經(jīng)獲得了CE標(biāo)簽。

Archus主席兼執(zhí)行總裁Jim Fitzsimmons評(píng)價(jià)說(shuō)：“CE標(biāo)簽對(duì)Archus公司而言是一個(gè)新的里程碑，是對(duì)這種重要的新型設(shè)備過(guò)去3年研制過(guò)程中嚴(yán)格的科研、設(shè)計(jì)、以及測(cè)試的合法確認(rèn)。”

Fitzsimmons主席指出：此時(shí)公司不會(huì)在歐洲全力推廣應(yīng)用，“我們的最初的計(jì)劃是與一些著名的中心采取細(xì)致的、探索性途徑來(lái)積累這種設(shè)備的臨床應(yīng)用經(jīng)驗(yàn)。”
 
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.”