AMI’s TubeClear System Receives Additional FDA Clearances

Actuated Medical Inc. (AMI) has received U.S. Food and Drug Administration (FDA) clearance on three additional TubeClear System Clearing Stem models. The FDA clearance enables the TubeClear System to operate in feeding tubes as narrow as 6 French (2 mm), which expands the capability of the TubeClear System to gastrostomy, jejunostromy, and nasoenteral feeding and decompression tubes between 6 and 18 French in adult patients. The FDA clearance also enables licensed or certified healthcare practitioners to use the TubeClear System to clear the clogged feeding tubes at a patient’s bedside.
 
“We are excited by the additional FDA clearance. The ability to clear clogs in smaller diameter feeding tubes opens new U.S. and international markets. It also enables paramedics to potentially clear clogged tubes in the patient’s home avoiding transportation and hospital readmission costs,” AMI President and CEO Maureen L. Mulvihill said.
 
Feeding and decompression tubes are used to supply nutrition and medication to patients that cannot self-feed. These tubes are narrow in diameter and clog at about a 25 percent rate ( about 1.7 million clogs annually). Caregivers spend significant time trying to clear the clogged tubes. When a tube cannot be cleared, the tube must be replaced which means another costly, invasive procedure for the patient. (The costs of feeding tube replacement can be more than $1,200 per instance when accounting for clinician time, effort and associated supplies.) The TubeClear System clears clogged feeding tubes at the patient’s bedside, while the tube remains in the patient. Comparison testing has shown that the TubeClear System works in minutes and is more effective than other methods used in the industry. It is expected that the replacement rate in environments where the TubeClear System is utilized will be significantly reduced.
 
“Nasogastric feeding tube insertion is a painful experience. Therefore clinicians often use smaller diameter feeding tubes for comfort and/or to accommodate a patient’s size. With this FDA clearance, AMI offers a solution to clear smaller diameter tubes at the patient’s bedside. The idea of reducing patient pain and unnecessary invasive procedures is what drives us, at AMI, to continue to innovate.” said Joe Kroll, AMI’s director clinical education.
 
The TubeClear system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed and manufactured by Actuated Medical in the United States.

Actuated Medical develops and manufactures minimally invasive medical devices to enhance clinical care and deliver positive patient outcomes. Actuated Medical a certified women-owned business located in Bellefonte, Pa., and is ISO 13485:2003-certified.