Thousand Oaks, Calif.-based ECA Medical Instruments and Charlotte, N.C.-based Intelligent Implant Systems LLC together have developed a complete spinal implant instrument fixation kit that is 100 percent disposable. The sterile packed kit features the a range of fixation instruments including a single-procedure cannulated torque limiters, ratchets and fixed drivers needed by orthopedic surgeons to perform both open and minimally invasive surgeries (MIS). Other pieces in the pack include awls, pedicle probes, driver shafts, all of which are disposable.

Branded as the I2S Revolution system, the pack is a pre-sterilized, single-use posterior spinal fixation procedural system. The fusion implants and instruments are packaged as a bundled solution. The included 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.

“We’re helping transform healthcare economics by providing our OEM implant customers with robust and tailored disposable instruments and fixation kits as alternatives to traditional and costly reusable tools,” said John Nino, ECA president and CEO. “Adoption of disposable kits across the orthopedic market is saving hospitals and ASCs on inventory and operating costs, improving patient safety, reducing risk of surgical site infection and increasing OR efficiency levels.”

“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 like I2S to offer cost savings, operating room efficiency gains and increased patient safety to hospitals and ambulatory surgical centers (ASCs) as every torque-limiter 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 over $1,200 per procedure using the disposable instrument set with the I2S Revolution kit and the healthcare industry several billion dollars a year by converting to single-use instrumentation.

Commercial launch of the new I2S Revolution system featuring ECA’s disposable instrument set is under U.S. Food and Drug Administration (FDA)510(k) review and not currently available for sale. Once approved by FDA it will be available via distributors throughout North America. Focus will be on serving ASCs as well as hospitals. As well as being disposable, the kits are biodegradable and recyclable.

ECA Medical and I2S are showcasing the Revolution kit solution at the North American Spine Society (NASS) conference in San Francisco, Calif. from Nov. 12 through 15. They will be exhibiting at booth #2245.