Eitan Medical’s Sapphire Infusion Pump Receives FDA Clearance

NETANYA, Israel (January 20, 2021)—Eitan Medical, a global leader in advanced infusion therapy and drug delivery solutions across the care continuum, announced that its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Sapphire infusion system is the company’s flagship infusion device, and is used across the United States within alternate sites, homecare markets, emergency medical services (EMS) and hospitals.
 
The compact and robust Sapphire infusion pump is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood, and blood products, making it suited for complex and demanding medical scenarios. The pump’s smart technology includes a full-color touch screen for intuitive and fast operation, built in safety mechanisms aimed to enhance patient safety, and advanced technology that helps minimize dosage errors and false alarms.
 
The most recent hardware and software upgrade adds a number of key improvements, utilizing the Sapphire family’s future-ready features. The new device features include:
 

• Perineural route was added to the Sapphire intended use to support a wider range of pain management therapies
• Software update to simplify workflows by reducing key presses and message prompts, and enhancing preset programs
• Updated epidural portfolio with NRFit dedicated connectors

Improved maintenance PC Suite functionality:

• FasTest PM—an on-site preventative maintenance solution designed to increase efficiency. FasTest PM enables quick and intuitive pump certification testing, supported with a downloadable manufacturer certificate. FasTest PM is capable of testing eight pumps simultaneously with an average pump testing time of five minutes, streamlining annual maintenance and testing between patients.
• Sapphire Configuration Manager—Sapphire is a fully customizable infusion device, that can be configured to the different clinical use. Sapphire Configuration Manager is a tool that allows for faster, simpler, and reliable configuration management across a fleet of pumps. Sapphire Configuration Manager enables users to export, save, share, and load configurable settings, drug libraries and preset programs. Promoting standardization by simplifying the creation of presets programs and configuration settings while significantly reducing resources required to manage these critical tasks.

 
“At Eitan Medical, we develop innovative and reliable technologies to provide a world-class user and patient experience via our drug delivery and advanced infusion solutions,” said Roger Massengale, CCO of Medication Delivery Solutions at Eitan Medical. “For over a decade, the SapphireTM infusion pump has established itself as an extremely capable and easy to use across the health care continuum. This clearance is an example of our continued dedication to innovation making our pumps easier to use for providers and safer for patients.”

Visit eitanmedical.com for more information.