Intelligent Implant Systems Receives 510(k) Clearance for Two-Level Revolution™

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Existing All-Sterile System Expands to Accomodate Two-Level Fusions

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Intelligent Implant Systems announced today that the two-level components for the Revolution™ Spinal System were cleared by the FDA via 510(k) for sale in the United States. These components expand the capabilities of the system and allow Revolution™ to be utilized for two-level posterior thoraco-lumbar fusions. With one-level sales beginning in October of 2015, the company has seen significant sales growth in 1Q 2016, and the system is currently being used at both hospitals and ASC’s in several regions across the United States. Revolution™ is intended to simplify single and two-level thoraco-lumbar fusions by providing a sophisticated novel implant system which is implanted with a single tray of all-sterile instruments. Implants are also provided sterile, eliminating the need for the hospital or ASC to sterilize anything for the procedure. The procedure is fast: place the pedicle screws, attach the connectors, and lock with the single-use torque wrench. There are no rods to contour, and with the locking mechanism built in, there are no set screws to place and potentially cross-thread.

Marc Richelsoph, CEO of Intelligent Implant Systems said: “Intelligent Implant Systems is committed to expanding our pioneering efforts in the all-sterile lumbar implant market. With the addition of the two-level components, the potential usage of the implant system now applies to the majority of patients, as most fusions are one and two-level. The same benefits of the system apply to the hospital and ASC: a simplified procedure, one tray of single-use instruments to make the procedure faster, and a potentially reduced risk of infection for the patients. OR turn time can be accelerated, as there is no need to clean and sterilize instruments, and there is no need for inventory management by the hospital or ASC.”

The new components allow expansion to two-level fusions while maintaining the simplicity and existing capabilities of the Revolution™ system. The same single-use instrument tray is used for a one or two-level procedure. The two-level system utilizes the existing Revolution™ Connectors, and requires only a minimum of additional components. The unique and extremely controllable compression and distraction provided by the system is maintained, setting the system apart from any other system on the market. All implants are UDI compliant, with individual bar coding and labels to provide inventory and tracking information.

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. Distribution is handled by our independent sales force, which continues to expand.

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Michael Nutt
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