ECA Medical's disposable spinal system gets FDA clearance — 5 things to know

Spinal Tech

ECA Medical Instruments received FDA clearance for its Intelligent Implant Systems Revolution Spinal System, which includes the company's sterile pack and disposable instrument set.

The instrument set is designed to ease workflow, save costs and boost operating room efficiency for both the inpatient and outpatient settings. Here are five things to know about the system:

 

1. The Intelligent Implant System Revolution Spinal System is a sterile-packed kit with a full complement of fixation instruments in the single sterile packaged tray.

 

2. The system is designed for posterior spinal fixation implant for single- or two-level constructs. The instruments and implants are packaged as a "bundled solution."

 

3. Healthcare facilities don't need to clean or reprocess the instruments prior to every procedure. They are single-procedure instruments to minimize the risk of infection from cross contamination.

 

4. The FDA approval allows the company to rapidly advance system distribution throughout North America, with a focus on serving ASCs as well as hospitals.

 

5. The Intelligent Implant Systems Revolution Spinal System will be available on the marketplace starting in the second quarter of 2015.

 

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