Trovita Health Science has announced the 510(k) submission for clearance of a new tube feeding system offering the first and only method for administering bolus or gravity tube feeding in a fully closed system, without the need for pouring formulas through a syringe, or utilizing an electronic pump system.
The single-use, disposable feeding device will enable patients and care givers to directly administer Trovita's proprietary, pre-filled nutrition formulas without exposing the food to potential contaminants, as well as offering greater portability, and a reduction in feeding time resulting from a substantial simplification of the bolus tube feeding process.
The SAFE-T FEED™ Pouch incorporates the standardized ENFit® nutrition connectors, which are mandated for implementation among all devices used in the administration of nutrition through feeding tubes.
Trovita's feeding system is highly portable, discreet, and does not require the use of a pump to conduct feedings through a gastronomy tube (G-tube). In conjunction with the new feeding system,
Trovita will market a new line of tube feeding formulas called Ultrient Ready-to-Feed, which will be the only formulas packaged in the device.
In addition to pending patents protecting the method of administration, a patent-pending "no spill" spout will allow for refrigerated storage if a feeding cannot be completed in a single session – with no cap required.
"The FDA submission of the SAFE-T FEED system is a significant milestone toward improving quality of care for people who require tube feeding," noted William Brown, Trovita's CEO.
"Our mission at Trovita is to address important patient care needs related to receiving both proper and better quality nutrition. As many as one-third of patients on feeding tubes are malnourished as a direct result of not being able to complete daily feedings due to the limitations of the current bolus feeding approach.
“By offering a system that can allow patients to easily receive their full nutritional requirement, Trovita can make a positive impact on the lives of patients and their families, and potentially reduce downstream healthcare consumption resulting from malnutrition or tube feeding complications."