January 3, 2011 – The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market a new component of the CyberKnife VSI System. The clearance of the Lung Optimized Treatment lets Accuray provide physicians with greater flexibility in delivering radiosurgery treatments to patients with lung cancer.

Recent studies have found radiosurgery to be an effective treatment option for medically inoperable lung cancer patients as it provides good local control and survival rates. Treating these tumors is particularly complex due to movement with respiration and nearby critical structures. This is especially the case for central and chest wall tumors, which are located in close proximity to critical anatomical structures.

Lung Optimized Treatment offers the accuracy and steep dose fall off required to safely treat lung tumors, even those close to critical structures. Simulation and comparison workflows, combined with unique tracking modes, allow the clinician to select from multiple noninvasive options, providing lung stereotactic body radiation therapy (SBRT) patients the optimal noninvasive treatment option, regardless of tumor location.

"This new technology enables treatments throughout the lung without a single incision, all while safeguarding healthy tissue and structures around the tumor to ensure they are not damaged by radiation," said Chris A. Raanes, senior vice president and chief operating officer for Accuray.

Because fiducial implantation is no longer required, radiosurgery with Lung Optimized Treatment offers a completely noninvasive option, which is particularly important for medically or surgically inoperable patients. This means patients who are not candidates for fiducial placement or physicians who choose not to implant fiducials due to the high risk of pneumothorax, now have a noninvasive alternative.

The CyberKnife Robotic Radiosurgery System is a robotic radiosurgery system designed to treat tumors anywhere in the body noninvasively. Using continual image guidance technology and computer controlled robotic mobility, the system automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the system to deliver high-dose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.

For more information: www.accuray.com


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