以色列superDimension公司推出肺部气道导航系统

美迪医疗网报道：一种导航系统可以引导内窥镜设备在肺部三维地图上行进，包括气管镜不能达到的区域。该系统已经获得美国食品药品管理局批准。

当前，在肺组织外周区域进行气管镜操作是几乎盲法进行的，而外周区域是大多数病变所在区域，但是气管镜本身不能到达。因此，大多数气管镜检查得不到目的区域的内窥镜检查资料，以至于手术的成功比例相当低，经常得到不可靠的检查结果。类似困难还阻碍了对淋巴结的检查，而淋巴结活检对肺癌的分期相当重要。新系统的设计能够克服这些差异，而无论是使用哪个厂家的标准气管镜、诊断或者治疗气管镜。2003～2004年在欧洲和以色列成功进行了有关外周肺组织病变活检的临床试验。

该系统叫做superDimension/Bronchus，包含了10项美国，被Technology Review (Massachusetts Institute of Technology,Boston, USA)评选为2004年世界上五大出类拔萃之一，而且是五项中唯一的医疗保健。

superDimension公司(Tel-Aviv, Israel)总裁兼首席执行官David Tolkowsky说：“FDA批准的是该系列产品中的第一个，我们计划来年在介入肺脏学领域中推广这种产品。”正是该公司将该系统进行了商品化。

Navigation System for Pulmonary Tract
 
A navigation system guides endoscopic instruments on a three-dimensional (3D) roadmap of the lungs, including areas beyond the reach of a bronchoscope. The system has been cleared by the U.S. Food and Drug Administration (FDA).

Currently, bronchoscopy is performed rather blindly in the peripheral areas of the lungs, where most lesions are situated but where the bronchoscope itself cannot reach. Therefore, most bronchoscopies are performed without endoscopic vision of the targeted area, so that success rates of the procedure are low, and unreliable results are common. Similar difficulties hinder access to the lymph nodes, where proper biopsy is critical for the staging of lung cancer. The new system is designed to correct these deficiencies while making use of any standard bronchoscope and any standard diagnostic or therapeutic bronchoscopic tool from any vendor. Successful clinical trials on the biopsy of peripheral lung lesions were conducted in Europe and Israel in 2003-2004.

The system, called superDimension/Bronchus, is covered by 10 U.S. patents and was selected this year by Technology Review (Massachusetts Institute of Technology, Boston, USA) as one of the five most outstanding patents in the world for 2004, and was the only healthcare patent among those five.

“This FDA approval is the first in a series of products that we plan to introduce in coming years in the field of interventional pulmonology,” remarked David Tolkowsky, president and CEO of superDimension (Tel-Aviv, Israel), which is commercializing the system.