US-based ECA Medical Instruments has obtained approval from the US Food and Drug Administration (FDA) for its newly developed disposable spine implant fixation instrument kit.
The disposable spine implant fixation kit has received the FDA 510(k) approval for use with the Intelligent Implant Systems (IIS) Revolution Spinal System.
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 centers (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 sterile-packed kit comprises full complement of fixation instruments in a single sterile packed tray, including cannulated torque-limiters, ratchets and fixed drivers.
According to the company, the specialized instruments will allow surgeons to carry out open and minimally invasive surgeries (MIS) in both inpatient and outpatient facilities.
ECA plans to start the marketing of disposable spine implant fixation kit from the second quarter of this year.
The IIS Revolution Spinal System has been designed for posterior spinal fixation implant of single or two-level constructs. It helps hospitals and ASCs to increase productivity, reduce operational cost, insure accurate implant fixation and control surgical site infection.
Image: FDA 510(k) approval has been granted for ECA’s spine implant fixation kit. Photo: courtesy of Business Wire.