一種新型支架能夠自我擴張，鎳鈦諾支架覆蓋在輸送系統(tǒng)中，使其能夠到達并擴張大腦狹窄的動脈。美國食品與藥品管理局已經(jīng)授予了“人道主義設(shè)備豁免”許可，允許該系統(tǒng)用于治療動脈粥樣硬化疾病，適用那些對藥物治療沒有應(yīng)答的患者，用于改善大腦動脈內(nèi)腔的直徑。

該許可是根據(jù)在歐洲12個單位進行的安全性臨床研究作出的。該研究入選患者是顱內(nèi)疾病導(dǎo)致的腦卒中患者，藥物治療沒有能夠預(yù)防腦卒中的再次發(fā)作。支架手術(shù)成功率為97.7％，30天內(nèi)的死亡或者相同大腦半球腦卒中的發(fā)生率為4.4％。

這套Wingspan系統(tǒng)和Gateway經(jīng)皮經(jīng)管腔血管成形術(shù)(PTA)氣囊導(dǎo)管是Boston科學(xué)公司的產(chǎn)品。

2005年8月在美國夏威夷Oahu舉行的年會上，美國介入治療神經(jīng)放射學(xué)學(xué)會主席John Barr醫(yī)生指出：“顱內(nèi)動脈粥樣硬化疾病是一種嚴(yán)重的疾病，當(dāng)前的藥物控制仍然不能確保許多患者面臨再次發(fā)作腦卒中的風(fēng)險。這項臨床研究提示：Wingspan設(shè)備能夠安全的擴張動脈，為預(yù)防缺血性腦卒中帶來了新的希望。”
 
Stent System for Brain Arteries
 
A new stent is a self-expanding, nitinol stent sheathed in a delivery system that enables it to reach and open narrowed arteries in the brain. The U.S. Food and Drug Administration (FDA) has granted a humanitarian-device exemption (HDE) approval of the system for the treatment of atherosclerotic disease and its use is indicated for improving cerebral artery lumen diameter in patients who have been unresponsive to medical therapy.

The approval was based on a safety study conducted at 12 sites in Europe. The study enrolled patients who had a stroke caused by an intracranial lesion and for whom medical treatment failed to prevent another stroke. The stent had a procedural success rate of 97.7% and showed only a 4.4% incidence of death or stroke in the same hemisphere of the brain within 30 days.

The Wingspan system with Gateway percutaneous transluminal angioplasty (PTA) balloon catheter is the product of Boston Scientific (Natick, MA, USA).

“Intracranial atherosclerotic disease is a serious condition and current medical management still leaves many patients at risk for another stroke,” noted John Barr, M.D., president of the American Society of Interventional Therapeutic Neuroradiology (ASITN), speaking at the ASITN annual meeting in Oahu (Hawaii) in August 2005.

“This study suggests that the Wingspan device can open arteries safely and offers new hope for the prevention of ischemic stroke.”