FDA Clears ECA Medical’s Disposable Spine Implant Fixation Kit

Thousand Oaks, Calif.-based ECA Medical Instruments, which makes single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its disposable spine implant fixation kit. The kit is cleared for use in with the Intelligent Implant Systems (IIS) Revolution Spinal System and will be available in the second quarter of 2015.

The sterile-packed kit features a full set of fixation instruments in a single sterile packed tray including proprietary and industry first cannulated torque-limiters, ratchets and fixed drivers. Surgeons use these specialized instruments to perform both open and minimally invasive surgeries (MIS) in both inpatient and outpatient facilities.

“This single tray of instruments is game changing for our industry and FDA approval signals a new era is taking hold with potential to transform healthcare economics,” said John Nino, president and CEO of ECA Medical Instruments. “Surgeons, hospitals, ambulatory surgical centers (ASCs) and patients all benefit from cost savings, increased safety and superb outcomes. The IIS Revolution set with ECA’s instruments was designed to make that sustained and measurable value a reality.”

The IIS implants 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, the company reports.

“We are excited to be launching the Revolution Spinal System, and the feedback from surgeons, distributors, [operating room] staff and sales people has been exceptional,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems LLC. “By providing sterile state-of-the-art implants combined with a single sterile tray of disposable instruments by ECA, we are leading the way to a better approach for spinal surgery.”

All ECA instruments for the Revolution spinal fusion kit are single-procedure and disposable, which is hoped to simplify 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 percent 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.

With this FDA approval, IIS plans to rapidly advance the Revolution Spinal System with its distributors throughout North America. Focus will be on serving ASCs as well as hospitals. The kits and instruments are disposable, biodegradable or recyclable.