Ohio company’s surgery simulator secures FDA approval

Elyria-based Surgical Theater has received FDA approval of their Selman Surgery Rehearsal Platform (SRP), making it the only patented and approved platform for cerebral and spine pre-surgery simulation.

Using standard scanned images from the patient, the SRP generates 3-D patient specific and accurate models showing the interaction between life-like tissue and surgical instruments. The animated tissue “responds” 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 surgery planning.

“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,” said Surgical Theater President & CEO Moty Avisar.

“A surgeon’s main priority is to provide the best treatment for their patients,” Avisar added. “The SRP offers a one-of-a-kind opportunity through pre-procedure rehearsal to reduce risk and maximize the chance for superior outcomes.”

Surgical Theater launched SRP 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 Case Medical Center in Cleveland. Physicians at the medical center have been instrumental in the company’s development.

“It is widely accepted that ‘purposeful practice makes perfect’ and having a tool like the SRP provides that opportunity and 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. Dr. Selman is a co-originator of the Platform’s development.

Spine Surgery Rehearsal Platform Approved by FDA

The FDA approved Surgical Theater’s Selman Surgery Rehearsal Platform, one of the only patented and approved platforms for cerebral and spine pre-surgery rehearsal, according to Today’s Medical Developments.

The SRP generates 3-D models based on standard scanned images from patients that show the interaction between tissue and surgical instruments. The pre-surgical analysis offers a rehearsal for surgeons and is ultimately designed to reduce risk and maximize outcomes, according to the report.

The device was released late last year after patent approval. Currently, the University Hospitals Case Medical Center in Cleveland uses the technology for clinical studies.

FDA Approval for Surgery Rehearsal Platform

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.

MRIs & CT scans become virtual 3-D models in rehearsal platform for high-risk brain surgeries

From the Article…

Collaberative TheaterMoty Avisar and Alon Geri have backgrounds in flight simulation. Dr. Warren Selman is neurosurgeon-in-chief at University Hospitals in Cleveland. Together, the three top minds behind Surgical Theater have developed a surgery rehearsal platform on which surgeons can practice the procedure they are about to perform on a specific patient and use a digital replica of the patient’s specific anatomy.

The Surgical Theater software takes MRIs and CT scans and constructs them into digital, interactive 3-D models with life-like tissue reaction. It’s run on the Surgery Rehearsal Platform, which includes models of real surgery tools that surgeons use to interact with the software.

 Read the Full Article

©Copyright . All rights reserved.
Menu
Menu