The US Food and Drug Administration (FDA) has granted 510(k) approval for ECA Medical Instruments‘ newly developed fully disposable spine implant fixation instrument kit.
The new disposable spine implant fixation kit was approved for use with the Intelligent Implant Systems (IIS) Revolution Spinal System and will be made available from the second quarter of this year.
The sterile-packed kit includes full complement of fixation instruments in a single sterile packed tray, including cannulated torque-limiters, ratchets and fixed drivers, which are necessary for surgeons to conduct both open and minimally invasive surgeries (MIS) in both inpatient and outpatient facilities.
ECA Medical Instruments president and CEO John Nino said: "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.
"Surgeons, hospitals, ambulatory surgical centres (ASCs) and patients all benefit from cost savings, increased safety and superb outcomes.
"The IIS Revolution set with ECA’s instruments was designed to make that sustained and measurable value a reality."
The IIS Revolution Spinal System has been designed for posterior spinal fixation implant of single or two-level constructs.
The system provides hospitals and ASCs a new pre-sterile implant and instrument set combination to increase productivity, reduce operational cost, insure accurate implant fixation and control surgical site infection.
Intelligent Implant Systems president and CEO Marc Richelsoph said: "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."
Image: World’s first disposable spine implant fixation kit receives FDA approvals. Photo: courtesy of Business Wire.