Trovita Health Science, announced U.S. Food and Drug Administration marketing authorization of the new SAFE-T FEED device for administering tube feeding formulas.
The nutrition delivery device is a ready-to-feed pouch offering pre-packaged with complete enteral formulas.
SAFE-T FEED simplifies the tube feeding process from over 60 steps to just seven, and eliminates pouring enteral formulas into an open syringe or gravity bag for feedings. This is important because a recent survey of 250 tube feeding patients and caregivers noted that 76 percent of patients experienced not meeting their daily nutrition requirements due to problems with their equipment or formulas. Malnutrition resulting from improper tube feeding may lead to increased healthcare costs due to hospital re-admissions and added physician visits.
SAFE-T FEED incorporates the ENFit nutrition connector, while also featuring a cap-less “No Spill” spout. The patent-pending, leak-proof connector allows SAFE-T FEED to be disconnected from a tube in the midst of a feeding and stored for later use. Trovita successfully demonstrated SAFE-T FEED achieved high flow rates when tested with high viscosity formulas, allowing for a wide range of enteral nutrition formulas to be pre-filled inside the disposable delivery device.
Along with the new delivery device, Trovita Health Science will launch Ultrient Ready-to-Feed, a new line of tube feeding formulas to be pre-packaged inside SAFE-T FEED for easy tube feeding. The new formulas will offer superior ingredients from real food sources, and low sugar levels consistent with the FDA and American Heart Association recommendation to limit daily sugar consumption. Trovita’s Ultrient Ready-to-Feed formulas will be the only enteral formulas available with SAFE-T FEED.
“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,” notes Will Brown, Trovita’s CEO. “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 healthcare costs in the process.”