Actuated Medical, a US-based medical device company, has obtained the additional US Food and Drug Administration (FDA) approval for its TubeClear system.
The company has added several new clearing stem models for the TubeClear system and this additional FDA approval allows to use the system in nasoenteral, gastrostomy, and jejunostomy feeding and decompression tubes.
In July 2012, Actuated Medical received the FDA approval for the TubeClear system to use in nasogastric tubes and it had also received CE Mark approval.
TubeClear system has reusable control boxes and single-use clearing stems and uses the company’s proprietary mechanical motion technology to clear clogs in feeding and decompression tubes without the discomfort and expense of removing them from the patient.
Actuated Medical president Dr Maureen L Mulvihill noted clogging is a significant problem occurring in approximately 25% of feeding and decompression tubes.
"With this latest FDA clearance the financial case becomes exceptionally strong. Using typical costs for clearing G and J tubes, our ROI Calculator shows annual savings of $243,000 for a typical 500-bed facility," Dr Mulvihill added.
TubeClear system is available in the US, Europe, the Middle East and North Africa.