ECA Medical Instruments® and Intelligent Implant Systems Unveil World’s First Pre-Sterile, Single-Procedure Spinal Fusion Kit

THOUSAND OAKS, Calif.–(BUSINESS WIRE)–ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits, has developed in partnership with Intelligent Implant Systems (I²S) the industry’s first complete spinal implant instrument fixation kit that is 100% disposable. The sterile packed kit features the full complement of fixation instruments including the industry’s first single-procedure cannulated torque limiters, ratchets and fixed drivers needed by orthopaedic surgeons to perform both open and minimally invasive surgeries (MIS) that offer potential for the best surgical outcomes at the best value.

“We’re helping transform healthcare economics by providing our OEM implant customers with robust and tailored disposable instruments and fixation kits as alternatives to traditional and costly reusable tools”

The I²S Revolution™ system is a pre-sterilized, single-use posterior spinal fixation procedural 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 fusion implants and instruments are packaged as a bundled solution. 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. The kit contains 100% disposable fixation tools including awls, pedicle probes, driver shafts and industry first cannulated torque-limiting handles, ratchet and fixed driver making them ideal for MIS procedures.

“We’re helping transform healthcare economics by providing our OEM implant customers with robust and tailored disposable instruments and fixation kits as alternatives to traditional and costly reusable tools,” said John Nino, ECA’s president & CEO. “Adoption of disposable kits across the orthopaedic market is 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 I²S to offer cost savings, OR efficiency gains and increased patient safety to hospitals and ASCs as every torque-limiter 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 I²S Revolution™ kit and the healthcare industry several billion dollars a year by converting to single-use instrumentation.

“We are pleased to have partnered with ECA for developing single-use and disposable instrumentation kits for our new Revolution™ System,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems. “The future of spinal implants will be cost effective sterile implant and instrument systems, and I²S is leading the way with the help of ECA, the market leader in single-use instrumentation.”

Commercial launch of the new I²S Revolution™ system featuring ECA’s disposable instrument set is under 510(k) review and not currently available for sale. Once approved by FDA it will be available via distributors throughout North America. Focus will be on serving ASCs as well as hospitals. All the kits are fully disposable, biodegradable and recyclable.

ECA Medical and I²S are showcasing the Revolution™ kit solution at the North American Spine Society (NASS) conference in San Francisco, CA. November 12 through 15. Surgeons and healthcare professionals may see the Revolution™ single-use implant and fixation kit at ECA Medial booth #2245 and at Intelligent Implant Systems booth #719. ECA Medical will also be displaying its complete line of single-procedure instruments and operational samples of spine & orthopaedic procedural kits.

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. 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