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FDA Approval for Surgery Rehearsal Platform

Manufacturing Group | February 23, 2013

Surgical Theater’s platform is the only patented and FDA approved platform for cerebral and spine pre-surgery.

Surgical Theater LLC, has received Food and Drug Administration approval of their Selman Surgery Rehearsal Platform (SRP), making it the only patented and FDA approved platform for cerebral and spine pre-surgery rehearsal in the marketplace. 

Using standard scanned images from any patient, the SRP generates 3D patient specific and accurate models showing the interaction between life-like tissue and surgical instruments. The tissue responds “realistically” to actions taken by the surgeon, enabling accurate pre-surgery planning and rehearsal. The unique software utilizes flight simulator technology to permit the remote connection of multiple SRPs; participants anywhere in the world can simultaneously work together, practice the same case with real-time feedback, and collaborate on the planning of a specific surgery case.

“Receiving FDA approval is confirmation of the innovative technology that our company has worked so hard to create over the last several years and the beginning of what we believe will be improved patient outcomes for cerebral and spine surgery patients,” states Moty Avisar, president and CEO, Surgical Theater. 

“A surgeon’s main priority is to provide the best treatment for their patients and the SRP offers a one-of-a-kind opportunity through pre-procedure rehearsal to reduce risk and maximize the chance for superior outcomes,” Avisar notes. “Now that the FDA cleared our SRP we expect it will become the surgeons' obvious choice and preference for gaining unique preoperative insight on how to best to accomplish their goals in surgery for each individual patient with the opportunity to "pre-live the future" of their cranial and spinal surgical procedures.” 

Surgical Theater launched the Platform late last year after receiving their first broad patent approval and submitting their application to the FDA. Early this year, the company completed the first sale of its groundbreaking technology to University Hospitals (UH) Case Medical Center in Cleveland. Physicians at the medical center have been instrumental in the development of Surgical Theater. 

“It is widely accepted that ‘purposeful practice makes perfect’ and having a tool like the SRP provides that opportunity and as such will help ensure improved patient safety and outcomes,” says Dr. Warren Selman, chairman, Department of Neurological Surgery, UH Case Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH. Selman is a co-originator of the Platform’s development. 

The Neurological Surgery Department at UH Case Medical Center has been using the SRP for over two years, and provided clinical insight to the company during its development. The Hospital has been using the Platform for clinical studies to document the value of pre-surgical rehearsal, and for resident and fellow education. Now with FDA approval, the Platform will be additionally used for patient care.

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