Boston科学公司推出大脑动脉支架

 
一种新型支架能够自我扩张，镍钛诺支架覆盖在输送系统中，使其能够到达并扩张大脑狭窄的动脉。美国食品与药品管理局已经授予了“人道主义设备豁免”许可，允许该系统用于治疗动脉粥样硬化疾病，适用那些对药物治疗没有应答的患者，用于改善大脑动脉内腔的直径。

该许可是根据在欧洲12个单位进行的安全性临床研究作出的。该研究入选患者是颅内疾病导致的脑卒中患者，药物治疗没有能够预防脑卒中的再次发作。支架手术成功率为97.7％，30天内的死亡或者相同大脑半球脑卒中的发生率为4.4％。

这套Wingspan系统和Gateway经皮经管腔血管成形术(PTA)气囊导管是Boston科学公司的产品。

2005年8月在美国夏威夷Oahu举行的年会上，美国介入治疗神经放射学学会主席John Barr医生指出：“颅内动脉粥样硬化疾病是一种严重的疾病，当前的药物控制仍然不能确保许多患者面临再次发作脑卒中的风险。这项临床研究提示：Wingspan设备能够安全的扩张动脉，为预防缺血性脑卒中带来了新的希望。”
 
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.”