IIS Revolution™ spinal fusion system features an all-sterile implant and sterile disposable instrument set and represents a fundamental change to the way single and two level posterior lumber spinal fusions are performed.
Intelligent Implant Systems, LLC is pleased to announce today that Revolution™ Spinal System has been officially launched and multiple surgeries have been completed with this new posterior thoracolumbar spinal fusion system. The surgeries were performed by Dr. William Hunter of the Neuroscience & Spine Center of the Carolinas. The Revolution™ Spinal System pioneers a new approach to lumbar spinal fusion by providing an advanced all-sterile implant and instrument set, which has numerous advantages over conventional thoracolumbar spinal fusion systems.
The Revolution™ Spinal System allows approaches to treating spinal fusion cases in a manner never experienced before in the lumbar spine, while making the procedure simpler, faster, and more effective. Implants and instruments are provided sterile packed for single use only, eliminating numerous issues with processing multiple non-sterile trays at hospitals. Last week, a surgery was performed to correct a condition in the lower back from L5 to S1, and an additional surgery was performed to correct an L4-L5 condition. In both cases, the sterile-packed Revolution™ disposable instrument kit, manufactured by ECA Medical Instruments, was used in the procedure and held the full complement of disposable fixation instruments.
“We are very pleased to launch this new advanced system. This is the beginning of a change in the way single and two level spinal procedures are done and will be done in the future,” said Marc Richelsoph, President and CEO of Intelligent Implant Systems, LLC, based in Charlotte, NC. “There are numerous benefits provided by using a single sterile disposable set of instruments along with specially designed sterile implants.”
Conventional systems are provided to the hospital in multiple non-sterile trays that require the hospital to sterilize the implants and instruments prior to use. Instruments, sterilized before each case, are used for many cases and, as a result, can be worn or out of calibration. Revolution™ eliminates this risk by providing pristine sterile instruments for every case.
Spine procedures carry a risk of infection, and current literature suggests that a significant amount of wound contamination occurs during surgery. Trays of implants and instruments, when exposed to the OR environment, become a source of contamination. The Revolution™ system eliminates this source with pre-sterilized implants that are not opened from their sterile packaging until the surgeon is ready to implant. Additionally, a reduced number of instruments are required to implant the system, and these instruments are provided in a single pre-sterilized instrument tray which remains sterile until the packaging is opened. With the need for lot traceability becoming more important for spinal implants, eliminating non-sterile implants and placing the implants in pre-sterilized, bar coded packages provides superior tracking for the hospital and company. A single disposable sterile instrument tray also reduces required OR space and eliminates the need for post-operative handling, cleaning, and sterilization of instruments.
About Intelligent Implant Systems:
Based in Charlotte, North Carolina, Intelligent Implant Systems, LLC 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. http://www.intelligentimplantsystems.com
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. http://www.ecamedical.com
For further information, please contact Intelligent Implant Systems,