FDA grants marketing clearance to Accuray's CyberKnife VSI System Lung Optimized Treatment

Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market Lung Optimized Treatment, a new component of the CyberKnife® VSI™ System. The 510(k) clearance enables Accuray to provide physicians with greater flexibility in delivering radiosurgery treatments to patients with lung cancer, the most common and deadly cancer worldwide.

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 such critical anatomical structures.

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

"Lung Optimized Treatment is a new tool we developed to meet the clinical demand for more flexibility in treating lung cancer patients with radiosurgery and the desire to move away from reliance on fiducial markers," said Chris A. Raanes, senior vice president and chief operating officer for Accuray. "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."

Because fiducial implantation is no longer required, CyberKnife radiosurgery with Lung Optimized Treatment offers a completely non-invasive 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 non-invasive alternative using the CyberKnife System's unique tracking and correction capabilities.

"With the FDA 510(k) clearance of Lung Optimized Treatment, we've taken the CyberKnife technology to new heights and enabled care for an expanded group of patients," said Euan S. Thomson, Ph.D., president and chief executive officer of Accuray. "This is yet another step in our efforts to ensure physicians have access to the treatment choices necessary for their patient, based on the patient's specific needs. To this end, Accuray continues to investigate ways to improve patient care across various indications."