Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and turnkey procedural kits, announced today its custom disposable instrument kit was used to successfully secure the first Revolution™ Spine System lumbar implant from Intelligent Implant Systems, Charlotte, NC.
The implant surgery to correct a condition in the lower back in the L5 to S1 vertebrae, occurred on October 5 and was performed without incident by Dr. William Hunter of the Neuroscience & Spine Center of the Carolinas. The sterile-packed ECA kit used in the procedure held the full complement of disposable fixation instruments including the industry’s first single-procedure cannulated torque limiter, ratchet and fixed driver, awl, pedicle probes and compression shafts needed to perform the open surgery procedure.
“This first surgery is the beginning of a change in the way single and two level spinal procedures are done and will be done in the future. The efficacy and ease of use of deploying a single sterile packed instrument tray along with sterile implants is unparalleled. In addition, due to the implant design, it is a simpler procedure saving time in the operating room,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems. “The future of spinal implants will be sterile implant and instrument systems, and IIS is leading the way with the help of ECA, the market leader in single-use instrumentation.”
The IIS Revolution™ system is a pre-sterilized, single-use posterior spinal fixation system providing hospitals and ambulatory surgical centers (ASCs) a novel delivery method to increase productivity and reduce operational costs as well as curb risk of surgical site infection. The Revolution™ Spinal Fixation System is intended to 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.
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.
Page 2 First IIS Implant Surgery with ECA Medical Instruments disposable fixation kit
“This is a tremendous milestone. The ECA instruments performed as expected for Dr. Hunter and the surgical team in this novel and historic implant procedure,” said John Nino, ECA’s president & CEO. “The outcome was excellent and the ECA instrument set proved a cost effective and easy to use solution that will accelerate adoption of disposable kits across the orthopaedic and spine markets. Tailored and robust disposable implant products like the IIS Revolution™ implant and instrument kit are saving hospitals and ASCs on inventory and operating costs, improving patient safety, reducing risk of surgical site infection and increasing OR efficiency levels,” he said.
“The focus in healthcare is on gaining the best possible outpatient outcomes at the best price point or value,” said James Schultz, ECA’s executive vice president. “Our single-procedure instruments and kits allow OEMs like IIS to offer cost savings, OR efficiency gains and increased patient safety to hospitals and ASCs as every instrument used to secure an implant is sterile and 100% calibrated.”
ECA Medical Instruments estimates hospitals and ASCs with an average number of surgical cases can save over $1,200 per procedure using the disposable instrument set with the IIS Revolution™ kit and the healthcare industry several billion dollars a year by converting to single-use instrumentation.
Commercial launch is underway for the IIS Revolution™ system featuring ECA’s disposable instrument kit. The Revolution implant kit has FDA clearance and is available via distributors throughout North America. Focus is on serving ASCs as well as hospitals.
ECA and IIS are both showcasing the Revolution™ kit at the North American Spine Society (NASS) conference in Chicago, IL. October 14 through 17. Surgeons and healthcare professionals may see the Revolution™ single-use implant and fixation kit and surgical video at ECA Medial Instruments booth #729 and at Intelligent Implant Systems booth #1739.
About ECA Medical Instruments
ECA Medical Instruments®, an American Capital company (NASDAQ:ACAS), was founded in 1979 and located in Thousand Oaks, CA. ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 30 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2012 by the Pacific Coast Business Times. www.ecamedical.com
About Intelligent Implant Systems
Based in Charlotte, North Carolina, Intelligent Implant Systems was founded with the goal to develop and market innovative surgical solutions for orthopedics and both fusion and non-fusion applications of the spine. Since its inception, Intelligent Implant Systems has been granted multiple US patents with foreign and additional US patents pending to protect its core technology. The product portfolio includes implants and instrumentation for enhanced fixation technology, facet joint fusion, lumbar posterior fusion, deformity correction, cervico-thoracic posterior fusion, and lumbar interbody fusion. www.intelligentimplantsystems.com