Navigation System for Pulmonary Tract

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.




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