Intelligent Implant Systems Gains FDA Approval for the Revolution Spinal System™ with Disposable Instrumentation Kit from ECA Medical Instruments

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The Revolution Spinal System™ from IIS features a novel posterior spinal fixation system with individually packaged sterile implants and an all-sterile single use instrument kit developed by ECA Medical Instruments.

Intelligent Implant Systems, LLC (IIS) announced today its novel Revolution Spinal System™ for correction of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine has received 510(k) approval for market release by the US Food and Drug Administration (FDA). The pre-sterile implant system and single-procedure instrument set are the world’s first fully disposable system designed from inception to provide ease of use, cost savings, implant simplicity and best outcomes and value for surgeons, hospitals, surgical centers and patients.

Revolution™ uses simple bone screws and a unique connector design which replaces traditional spine rods while offering adjustability for angulation and length. By removing the need to contour and cut rods, Revolution™ allows for bone screws to be placed first, maximizing visualization and ease of screw placement. The design eliminates separate locking nuts or set screws, making the extremely low profile system easy to place in open and mini-open surgical procedures. Screws range in size from 4.5mm to 7.5mm in diameter and 5.5mm and larger are cannulated.

Revolution™ is a completely sterile posterior spinal fixation system with individually packaged implants and an all-sterile single use instrument kit. IIS partnered with ECA Medical Instruments, Thousand Oaks, CA. for the disposable kit development. IIS worked with ECA Medical Instruments to develop a low profile kit featuring a full complement of instruments in a single sterile packed tray. Instruments include industry first fully disposable 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.

In order to incorporate a single-use instrument kit, IIS designed a completely new implant system, eliminating expensive and complicated reusable, non-sterile instruments. Simplicity of design makes the IIS pre-sterile implant and instrument set combination ideal for hospitals and ASCs seeking ways to increase OR 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.

Revolution Spinal System™ will be available in the marketplace starting second quarter 2015. With this FDA approval, IIS will rapidly advance the Revolution Spinal System™ with its distributors throughout North America. The focus will be on serving ASCs as well as hospitals. All procedural kits including instruments are fully disposable, biodegradable or recyclable.

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 25 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

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