Calypso obtains IDE approval

Electromagnetic localization technology developer Calypso Medical Technologies has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for a clinical study evaluating real-time tracking of lung cancer tumors during radiation delivery.

Patient enrollment is planned at Washington University in St. Louis and the Cancer Treatment Centers of America in Tulsa, OK. Investigators in the U.S. will implant three anchored Beacon transponders in patients' lungs and use the Calypso system to precisely track tumor location and movement during lung cancer radiation therapy.

The clinical trial has been under way in Europe and South Africa since October 2010. Participating cancer centers include those at the University of Heidelberg, the University Hospital Basel, and the University of Stellenbosch's Tygerberg Hospital in Cape Town, South Africa.

Early data on the implantation of the electromagnetic transponders in lung cancer patients from the clinical trial will be presented at the American Society for Radiation Oncology (ASTRO) annual meeting in Miami Beach, FL.

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