ECA Medical Disposable Fixation Kit Used in First Spinal Surgery

Doctors in North Carolina recently were the first to use ECA Medical Instruments’ IIS Revolution Spine System lumbar implant from the Intelligent Implant Systems in a successful surgery.

The procedure to correct a lower back condition in the L5 to S1 vertebrae occurred on Oct. 5 and was performed by William Hunter, M.D., of the Neuroscience & Spine Center of the Carolinas in Charlotte, N.C. The ECA kit used in the procedure featured a full complement of disposable fixation instruments, including the industry’s first single-procedure cannulated torque limiter, ratchet and fixed driver, awl, pedicle probes and compression shafts needed to perform the open surgical procedure, company executives announced in a news release.  

“This first surgery is the beginning of a change in the way single- and two-level spinal procedures are done and will be done in the future. The efficacy and ease of use of deploying a single sterile packed instrument tray along with sterile implants is unparalleled. In addition, due to the implant design, it is a simpler procedure saving time in the operating room,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems. “The future of spinal implants will be sterile implant and instrument systems.”

The IIS Revolution system is a pre-sterilized, single-use posterior spinal fixation system that provides hospitals and ambulatory surgical centers (ASCs) a delivery method to increase productivity and reduce operational costs as well as curb the risk of surgical site infection. The Revolution Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

“This is a tremendous milestone. The ECA instruments performed as expected for Dr. Hunter and the surgical team in this implant procedure,” said John Nino, ECA president and CEO. “The outcome was excellent and the ECA instrument set proved a cost effective and easy to use solution that will accelerate adoption of disposable kits across the orthopedic and spine markets. Tailored and robust disposable implant products like the IIS Revolution implant and instrument kit are saving hospitals and ASCs on inventory and operating costs, improving patient safety, reducing risk of surgical site infection and increasing OR efficiency levels.”  

All ECA instruments for the Revolution spinal fusion kit are single-procedure and disposable, simplifying workflow by eliminating the need to clean and reprocess instruments before every procedure. Single-procedure instruments minimize the risk of infection due to cross contamination, ensuring pristine out-of-the-box instruments are used to support every patient procedure.                   

“The focus in healthcare is on gaining the best possible outpatient outcomes at the best price point or value,” said James Schultz, ECA’s executive vice president. “Our single-procedure instruments and kits allow OEMs to offer cost savings, operating room efficiency gains and increased patient safety to hospitals and ASCs as every instrument used to secure an implant is sterile and 100 percent calibrated.”

ECA Medical Instruments estimates hospitals and ASCs with an average number of surgical cases can save more than $1,200 per procedure using the disposable instrument set with the IIS Revolution kit and the healthcare industry several billion dollars a year by converting to single-use instrumentation.

Commercial launch is underway for the IIS Revolution system featuring ECA’s disposable instrument kit. The implant kit has been approved by the U.S. Food and Drug Administration.  

Founded in 1979, ECA Medical Instruments, an American Capital company, develops single-procedure torque-limiting instruments and surgical fixation kits. The Thousand Oaks, Calif.-based company claims it has manufactured and delivered more than 30 million precision torque instruments to the producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants, resulting in more than 500 million precision surgical actuations.