ECA Medical Instruments and Intelligent Implant Systems unveil the first pre-sterile, single-procedure spinal fusion kit


ECA Medical Instruments, in partnership with Intelligent Implant Systems (I2S), has developed the industry’s first complete spinal implant instrument fixation kit that is 100% disposable. The sterile packed kit features the full complement of fixation instruments including the industry’s first single-procedure cannulated torque limiters, ratchets and fixed drivers needed by orthopaedic surgeons to perform open and minimally invasive surgeries.

The I2S Revolution system is a pre-sterilised, single-use posterior spinal fixation procedural system. The fusion implants and instruments are packaged as a bundled solution. 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. Single-procedure instruments minimise the risk of infection due to cross contamination. The kit contains 100% disposable fixation tools including awls, pedicle probes, driver shafts and cannulated torque-limiting handles, ratchet and fixed driver.

“Adoption of disposable kits across the orthopaedic market is saving hospitals and ambulatory surgical centres on inventory and operating costs, improving patient safety, reducing risk of surgical site infection and increasing OR efficiency levels,” says John Nino, ECA’s president and chief executive officer.

James Schultz, ECA’s executive vice president adds: “Our single-procedure instruments and kits allow OEMs like I2S to offer cost savings, OR efficiency gains and increased patient safety to hospitals and ASCs as every torque-limiter used to secure an implant is sterile and 100% calibrated.”

ECA Medical Instruments estimates hospitals and ambulatory surgical centres with an average number of surgical cases can save over US$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 is under 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 ambulatory surgical centres as well as hospitals. All the kits are fully disposable, biodegradable and recyclable.

ECA Medical and I2S are showcasing the Revolution kit solution at the North American Spine Society (NASS) conference in San Francisco, USA from 12-15 November. Surgeons and healthcare professionals may see the Revolution single-use implant and fixation kit at ECA Medial booth #2245 and at Intelligent Implant Systems booth #719.