Pre-sterile, single-procedure spinal fusion kit

Thousand Oaks, California – 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. 

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. 

Source: ECA Medical Instruments