News | May 20, 2008

FDA Clears Calypso’s GPS for the Body for Prostatectomy Patients

May 21, 2008 - Calypso Medical said the FDA cleared a new indication for the use of implantable Beacon electromagnetic transponders with the Calypso System in external beam radiation therapy.

Known as GPS for the Body, the Calypso System utilizes transponders to setup and continuously track the position of targeted tissue during radiation treatment. In the event that the tumor site moves outside of acceptable limits, the clinician adapts therapy during daily treatment to ensure the treatment is delivered as prescribed to the cancerous tissue while avoiding adjacent healthy organs. This is reportedly the only technology platform designed to provide objective, accurate and continuous tracking information during external beam radiation therapy without adding ionizing radiation. Radiation therapy is the standard of care for patients with a high risk of prostate cancer recurrence or those in whom recurrence has been diagnosed.

Previously this technology was cleared solely for use in patients with an intact prostate. Studies indicate up to 20 percent of prostatectomy patients are diagnosed with recurrent prostate cancer following surgery and require adjuvant radiation therapy.

"Patients with high Gleason scores, extracapsular extension, positive surgical margins or seminal vesicle involvement are at risk of developing biochemical failure following radical prostatectomy,” said David I. Lee, M.D., a University of Pennsylvania urologist. “These patients often need adjuvant radiation therapy. Having the benefit of continuous real-time tracking during radiation therapy is critical to minimizing possible complications associated with external beam radiation therapy. It is imperative to know precisely where the prostatic bed is located during radiation treatment. The objective tracking data, provided by the Calypso System, may be the key to achieving the desired outcomes for these aggressive cases.”

For more information: www.calypsomedical.com

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