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TubeClear Receives FDA Clearance for New GJ-Specific Clearing Stem Model

TubeClear Receives FDA Clearance for New GJ-Specific Clearing Stem Model

BELLEFONTE, PA – Actuated Medical, Inc. (AMI) recently received its sixth Food and Drug Administration (FDA) 510(k) clearance for the TubeClear® system. Clearance number K200646 introduces a Clearing Stem model that is compatible with select gastro-jejunostomy (GJ) feeding tubes.

These complex dual lumen feeding tubes are often expensive and require surgery to place. When a clogged feeding tube of any type cannot be cleared, it requires replacement. The new TubeClear GJ-1422 Clearing Stem offers a mechanical option for clinicians to keep these expensive GJ tubes clear and avoid an unnecessary procedure to replace the tube. The GJ-1422 Clearing Stem is designed to work with MIC*, MIC-KEY* (Avanos Medical, Inc., Alpharetta, GA) and G-Jet® (Applied Medical Technology (AMT), Brecksville, OH) GJ feeding tubes that are 14-22 French diameter and have a jejunal length of 15-45 centimeters.

“Clogging in GJ tubes is one of the most common complaints we hear from clinicians and patients alike,” said AMI president and chief executive officer Maureen L. Mulvihill, PhD. “Being able to deliver a Clearing Stem that is compatible with our existing TubeClear system as well as GJ feeding tubes is an exciting opportunity for AMI to support vulnerable patients and improve their outcomes.”

The TubeClear system is an FDA cleared medical device that uses patented mechanical motion technology to maintain flow and clear clogs in most feeding and decompression tubes while the tube remains in the patient and works at bedside. Keeping these tubes clear prevents interruptions to feeding and medication delivery, allowing clinicians to maintain their focus on improving patient care and reducing healthcare cost associated with tube replacement. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by AMI in Bellefonte, PA. The new GJ Clearing Stem is slated to be available for sale in clinical settings in early 2021.

 

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About Actuated Medical, Inc.

Actuated Medical develops medical devices that integrate electronically controlled motion technologies that improve patient outcomes and reduce healthcare costs. Their development process focuses on intellectual property, regulatory, and reimbursement strategies to decrease commercialization risk and attract medical device technology licensing partnerships. Their devices solve unmet clinical needs in target markets (e.g., GI, oncology, critical care and pediatrics). Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485:2016 certified.

For more information, please visit http://www.actuatedmedical.com

 

Malnutrition Prevalent in Older Adults – Tuesday Tube Facts

Did you know…?

Malnutrition is highest among older adults (65+). Hospital stays with malnutrition are 2x longer than those without.[1]

Patients treated for Covid-19 may require a feeding tube to help supplement their nutrition to fight the infection.[2] Keeping these tubes clear by proactively using the TubeClear system may help maintain feeding tube flow so these patients keep getting the nutrition they need for recovery.[3]

References:

  1. Barrett ML, Bailey MK, Owens PL. “Non-maternal and Non-neonatal Inpatient Stays in the United States Involving Malnutrition.” U.S. Agency for Healthcare Research and Quality. 2016. https://hcup-us.ahrq.gov/reports/HCUPMalnutritionHospReport_083018.pdf
  2. Garcia-Navarro, Lulu, host. “What Is The Treatment For COVID-19 Patients? A Doctor Explains.” Weekend Edition Sunday, NPR. March 15, 2020. https://www.npr.org/2020/03/15/816042230/what-is-the-treatment-for-covid-19-patients-a-doctor-explains
  3. Actuated Medical Inc. TubeClear Prophylactic Test Report: 1100791569, Rev002. 2019.

Device More Effective Than Flushing with Water – Tuesday Tube Facts

Did you know…?

The TubeClear system was 146% more effective at removing buildup from the inside walls of feeding tubes than flushing with water alone.[1]

Even with regular water flushes, feeding tubes still clog 15% of the time.[2]

References:

  1. Actuated Medical Inc. TubeClear Prophylactic Test Report: 1100791569, Rev002. 2019.
  2. Dandeles, L. and Lodolee, A. Efficacy of Agents to Prevent and Treat Enteral Feeding Tube Clogs. The Annals of Pharmacotherapy. 2011. 45:676-680.

Acidic Fluids May Coagulate or Thicken Clogs – Tuesday Tube Facts

Did you know…?

The use of acidic liquids to clear a clogged feeding tube may make the problem worse.[1,2]

Enteral feeding proteins coagulate or thicken in an acidic environment.[1,2]

References:

  1. Dandeles LM, Lodolce AE. Efficacy of agents to prevent and treat enteral feeding tube clogs. Ann Pharmacother. 2011;45:676-680.
  2. Williams NT.Medication administration through enteral feeding tubes. Am J Health-Syst Pharm. 2008;65:2347-2357.