ECA Medical Instruments, a leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits, developed the industry’s first fully disposable spine implant fixation instrument kit to gain FDA approval, the company announced. The industry-first 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 industry first cannulated torque-limiters, ratchets and fixed drivers. These specialized instruments are needed by surgeons to perform both open and minimally invasive surgeries (MIS) in both inpatient and outpatient facilities.
“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,” says John Nino, president and CEO of ECA Medical Instruments. “Surgeons, hospitals, ambulatory surgical centers (ASCs) and patients all benefit from cost savings, increased safety and superb outcoms. The IIS Revolution™ set with ECA’s instruments was designed to make that sustained and measurable value a reality."
The IIS Revolution Spinal System™ offers a simplified design for posterior spinal fixation implant of single or two-level constructs providing hospitals and ASCs 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 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 are excited to be launching the Revolution™ Spinal System, and the feedback from surgeons, distributors, OR staff and sales people has been exceptional. By providing sterile state-of-the-art implants combined with a single sterile tray of disposable instruments by ECA, we are leading the way to a better approach for spinal surgery,” says Marc Richelsoph, president and CEO of Intelligent Implant Systems, LLC.
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 minimize 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 percent disposable fixation tools including awls, pedicle probes, driver shafts and industry first cannulated torque-limiting handles, ratchet and fixed driver making them ideal for MIS procedures.
With this FDA approval IIS will rapidly advance the Revolution Spinal System™ with its distributors throughout North America. Focus will be on serving ASCs as well as hospitals. All the kits and instruments are disposable, biodegradable or recyclable.
Source: ECA Medical Instruments