ECA Medical Instruments’ fully disposable spine implant fixation instrument kit has received approval from the US Food and Drug Administration. The disposable spine implant fixation kit has been granted FDA 510(k) approval to be used with the Intelligent Implant Systems (IIS) Revolution Spinal System and will be available in the marketplace starting second quarter 2015.
The sterile-packed kit features a full complement of fixation instruments in a single sterile packed tray including proprietary and cannulated torque-limiters, ratchets and fixed drivers.
“This single tray of instruments is game changing for our industry and FDA approval signals a new era is taking hold with potential to transform healthcare economics,” said John Nino, president and chief executive officer of ECA Medical Instruments. “Surgeons, hospitals, ambulatory surgical centres and patients all benefit from cost savings, increased safety and superb outcomes.”
IIS says that its Revolution Spinal System offers a simplified design for posterior spinal fixation implant of single or two-level constructs providing hospitals and ambulatory care centres a novel pre-sterile implant and instrument set combination to increase productivity, reduce operational cost, insure accurate implant fixation and curb risk of surgical site infection. The spine implants and instruments are packaged as a bundled solution. The IIS implants 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. The kit contains 100% disposable fixation tools including awls, pedicle probes, driver shafts and industry first cannulated torque-limiting handles, ratchet and fixed driver making them ideal for minimally invasive procedures.
With this FDA approval IIS can now advance the Revolution Spinal System with its distributors in North America, with a focus will on serving ambulatory care centres as well as hospitals. All the kits and instruments are disposable, biodegradable or recyclable.