ECA Medical Instruments’ custom disposable instrument kit was used to successfully secure the first Revolution spine system lumbar implant from Intelligent Implant Systems (ISS).
The implant surgery to correct a condition in the lower back in the L5–S1 vertebrae was performed without incident by William Hunter of the Neuroscience & Spine Center of the Carolinas, USA. The sterile-packed ECA kit used in the procedure held the 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 surgery procedure.
“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 chief executive officer of Intelligent Implant Systems. “The future of spinal implants will be sterile implant and instrument systems.”
The IIS Revolution system is a pre-sterilised, single-use posterior spinal fixation system providing hospitals and ambulatory surgical centres (ASCs) a novel delivery method to increase productivity and reduce operational costs as well as curb risk of surgical site infection. The Revolution spinal fixation system is intended to provide immobilisation and stabilisation 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.
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 prior to every procedure. Single-procedure instruments minimise the risk of infection due to cross contamination, ensuring pristine out of the box instruments are used to support every patient procedure.
“This is a tremendous milestone. The ECA instruments performed as expected for Hunter and the surgical team in this novel and historic implant procedure,” said John Nino, ECA’s president and chief executive officer. “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 orthopaedic 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 operating room efficiency levels,” he said.
ECA Medical Instruments estimates hospitals and ASCs with an average number of surgical cases can save over US$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 Revolution implant kit has Food and Drug Administration clearance and is available via distributors throughout North America. Focus is on serving ASCs as well as hospitals.
ECA and IIS will both be showcasing the Revolution kit at the North American Spine Society (NASS) conference (14–17 October, Chicago, USA) at ECA Medial Instruments booth #729 and at Intelligent Implant Systems booth #1739.