Surgical Navigation Advanced Platform Receives FDA Clearance
CLEVELAND – Surgical Theater, LLC today received Food and Drug Administration (FDA) clearance on the recently launched Surgical Navigation Advanced Platform (SNAP). The SNAP integrates with operating room technology to provide advanced 3D capabilities and augmented reality, allowing surgeons to enhance their surgery performance and “see what cannot be seen.”
The SNAP is the second of the company’s line of products combining flight simulation technology with advanced CT/MRI imaging for use in brain surgery to receive FDA clearance. It enables surgeons to perform a real-life “fly through” of a “patient-specific” surgery and receive unique virtual reality guidance to determine the safest and most efficient pathway to remove cerebral tumors and treat vascular anomalies.
With the SNAP, surgeons can execute their surgery plan while in the operating room utilizing a patient’s CT/MRI scans, allowing enhanced accuracy and efficiency. It provides the ability to rotate the image or make it semi-transparent in order to see behind arteries and other critical structures, something not possible until now, affording for accuracy to be sustained during complex procedures. Also, SNAP’s augmented reality and simulation capabilities allow surgeons to analyze virtual “what if” scenarios before making the actual incision. This precision enables surgeons to gain clinical insight that was previously unavailable.
“We have used the SNAP in the operating room in a handful of surgeries. The SNAP’s realistic 3D imaging is one-of-a-kind and has been introduced as an integrated OR device for the first time at our medical center,” said Warren R. Selman MD, Chairman, Department of Neurological Surgery, University Hospitals Case Medical Center. “It is just like watching a football game when multiple cameras are located around the arena and an editor can freeze the image, rotate, zoom in, zoom out and see things that he could not otherwise see. In my recent surgeries, I was able to pause the navigation scene during the surgery to rotate the image and to verify that I removed the entire tumor and to make sure that I was within a safe distance from a vital artery while removing the tumor. With the SNAP connected to the OR navigation platform, the OR team coordination is enhanced, and we are utilizing the best imaging technology tool to benefit our patients.”
Surgical Theater’s first product, the Surgical Rehearsal Platform (SRP), paved the way to the operating room by providing surgeons with a way to plan and rehearse their surgeries outside of the operating room. To date it is estimated that the SRP has been utilized by surgeons wanting to pre-live their procedure more than 500 times. Now the SNAP will be utilized to take the pre-planned pathway into the operating room to be used during the surgical procedure thanks to its ability to integrate into operating room navigation equipment. In addition, the flight simulator technology used in the software permits remote connection of multiple platforms; participants anywhere in the world can simultaneously work together and practice the same case with real-time feedback and collaboration.
“We are extremely excited to expand our offerings beyond planning and rehearsing surgeries outside the OR,” said Moty Avisar, Surgical Theater CEO and Co-Founder. “The SNAP, our advanced imaging platform, allows us to connect to the operating room navigation system and become a part of the surgery as its performed, enabling a surgeon and OR team to achieve their goal of delivering the best care and outcome for the patient. We are witnessing strong anticipation from the medical community about this new technology, with multiple pre-orders for the SNAP already placed from hospitals across the country.”
Since Surgical Theater obtained FDA clearance on their first product in February 2013, SRPs have been installed in leading research and teaching hospitals across the United States. Hospitals include: University Hospitals Case Medical Center, University Hospitals Rainbow Babies and Children’s Hospital, The Ronald Reagan UCLA Medical Center, The Mount Sinai Hospital, Mayo Clinic, NYU Langone Medical Center, and others.
Surgical Theater has received generous recognition from the media. Last week, the company was named in Forbes as one of 10 Health Tech Companies Changing The World. Surgical Theater was also featured on CNN as a breakthrough technology in surgery, and also recently featured on FOX News and Extra.