ECA Medical Instruments Develops 1st Disposable Spinal Instrument Fixation Kit to Gain FDA Clearance with Intelligent Implant Systems

ECA Medical Instruments, the 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 today. 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 Systemâ„¢ 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,” said 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 outcomes. The IIS Revolutionâ„¢ set with ECA’s instruments was designed to make that sustained and measurable value a reality,” he said.

The IIS Revolution Spinal Systemâ„¢ 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.

Source: ECA Medical Instruments

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