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FDA clears device for simplifying enteral nutrition delivery
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The FDA has issued marketing clearance to a new enteral nutrition delivery device designed to simplify the administration of tube feeding formulas, the manufacturer announced.
Safe-T Feed (Trovita Health Science) is a disposable ready-to-feed pouch that provides a fully-closed system that comes pre-packaged with complete enteral formulas, according to a press release.
The device reduces the steps in the tube feeding process from more than 60 to seven, and does not require pouring enteral formulas into an open syringe or gravity bag.
“This is important because a recent survey of 250 tube feeding patients and caregivers noted that 76% of patients experienced not meeting their daily nutrition requirements due to problems with their equipment or formulas,” and subsequent malnutrition can increase health care use and costs, according to the press release.
Safe-T Feed showed high flow rates in tests with high viscosity formulas, so a range of formulas can be used. The device includes a cap-less no-spill spout and the new leak-proof ENFit nutrition connector, which allows the device to be disconnected from a tube during feeding to be stored and used again.
The company is also launching a new line of tube feeding formulas called Ultrient Ready-to-Feed, which will be the only enteral formulas available with the device.
“The FDA marketing clearance of Safe-T Feed is a significant advancement toward improving the quality of health care for people who require tube feeding,” Will Brown, Trovita’s CEO, said in the release. “Simultaneously advancing both the quality of nutrition with Ultrient Ready-to-Feed formulas, and offering a simplified administration device with Safe-T Feed is a major step toward eliminating unintended malnutrition with enteral feeding. Trovita Health Science will make a positive impact on the lives of tube feeding patients and their families, and we intend to help reduce downstream health care costs in the process.”
Disclosures: Brown is employed by Trovita Health Sciences.