Dec 4, 2020 | News, Press Releases
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
Mar 14, 2019 | News, Press Releases
FOR IMMEDIATE RELEASE: March 14, 2019
For more information:
Maureen L. Mulvihill, Ph.D./814-355-0003
www.ActuatedMedical.com
info@actuatedmedical.com
New Website for
the TubeClear System Features Improved Usability and Additional Clearing Stem
Models
BELLEFONTE,
PA – Actuated Medical, Inc. (AMI) announced the launch of its
updated website for the TubeClear system, www.TubeClear.com. This is the first overhaul of the site since
its original launch in 2012. The update optimizes lead generation tools while
providing updated information about the TubeClear system for visitors.
“We’re excited to unveil this new website to our customers,”
said Maureen L. Mulvihill, Ph.D., president and CEO of AMI. “We believe this update will help bring greater
awareness to a common problem in feeding tubes – clogs that disrupt a patient’s
vital nutrition and medication needs.”
The TubeClear system is a powered mechanical device for keeping
enteral access devices (e.g., feeding tubes) clear of buildup that can
eventually clog. The new website places
additional focus on presenting the problem that clogs create. Approximately 25% of feeding tubes clog, and
if they cannot be cleared, they must be replaced. Replacement risks include misplacement into the
lungs, which can lead to pneumothorax and even death. By keeping feeding tubes clear with the
TubeClear system, there is a reduced need to replace feeding tubes, thus
reducing these misplacement risks. In
addition, interruptions to a patient’s enteral nutrition have been found to
increase the patient’s hospital length of stay, adding to their cost of care.
In
2016, the TubeClear system received additional FDA 510(k) clearance for three
new Clearing Stem models. These Clearing
Stems allow facilities additional flexibility for inventory options as well as
serve feeding tubes as small as 6 French (2.33 mm) in diameter. The new models
recently became commercially available and more information about them is
included on the updated website.
The
TubeClear system is the only device of its kind on the market, and is
designated as an Innovative Technology Product by Vizient, Inc.
# # #
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 acquisition partnerships.
Their devices solve unmet clinical needs in target markets e.g., GI,
critical care and pediatrics. Actuated
Medical a certified women-owned business located in Bellefonte, PA and is ISO
13485 certified.
For more information, please visit http://www.actuatedmedical.com
Originally published on PRLog.
Nov 14, 2018 | Press Releases
FOR IMMEDIATE RELEASE: November 14, 2018
BELLEFONTE, PA – Actuated Medical, Inc. announced its TubeClear System has received an Innovative Technology contract from Vizient, Inc., the largest member-driven health care performance improvement company in the country. The contract was based on a recommendation of the TubeClear System by hospital experts in this category who serve on one of Vizient’s member-led councils. Innovative Technology contracts are reserved for technologies that demonstrate an ability to enhance clinical care or patient safety, and those that improve an organization’s care delivery and business model.
The TubeClear system is an FDA-cleared medical device that uses patented mechanical motion technology to clear occlusions in most enteral access devices (EADs) while the EAD remains in the patient and works at bedside. Clinical research estimates that 7 million enteral access devices are placed each year.1 With a clogging rate of about 25%,2 that is 1.7 million patients experiencing interruptions to their nutrition and medication due to clogged feeding tubes every year. Replacement risks include misplacement into the lungs, which can lead to pneumothorax and even death.
Keeping these EADs clear prevents interruptions to feeding and medication delivery, allowing clinicians to maintain their focus on improving patient care and reducing healthcare costs associated with tube replacement. The TubeClear system is the only powered mechanical system for clearing EADs on the market. Bench top analysis confirms that it is faster and more effective than current solutions such as flushing with water or using enzyme-based treatments. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by Actuated Medical in Bellefonte, PA.
Maureen L. Mulvihill, Ph.D. is Actuated Medical’s President and CEO, as well as one of the inventors of the TubeClear System. “We’re excited to be recognized as an innovative technology provider that is improving patient outcomes,” said Mulvihill. “Having a Vizient awarded contract, the TubeClear System allows members to have access to increased savings.”
The new multi-year contract for the TubeClear System begins November 1, 2018.
“After a full review of the TubeClear System, Vizient’s member council agreed this solution offers unique and incremental benefit over other products available on the market today, and recommended it for an innovative technology contract. We are pleased to award this new contract to Actuated Medical,” said Debbie Archer, director of procurement and leader of Vizient’s Innovative Technology program for suppliers.
Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents approximately $100 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to review potentially innovative products. If it is determined that a product is innovative, Vizient may award a contract outside of the competitive bid cycle.
# # #
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 acquisition partnerships. Their devices solve unmet clinical needs in target markets e.g., GI, critical care and pediatrics. Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485 certified.
For more information, please visit http://www.actuatedmedical.com
- Botoman VA, Kirtland SH, Moss RL. A randomized study of a pH sensor feeding tube vs a standard feeding tube in patients requiring enteral nutrition. JPEN J Parenter Enteral Nutr. 1994; 18 (2):154-158.
- Smith, R.M. and Myers, S. A. “2 devices that unclog feeding tubes.” RN. Jan; 68(1): 36-41; quiz 42 (2005).
Sriram, K., Jayanth, V., Lakshmi, R., George, V. “Prophylactic locking of enteral feeding tubes with pancreatic enzymes.” Journal of Parenteral and Enteral Nutrition. 21, 353-356 (1997).
Bourgault, A.M., Heyland, D.K., Drover, J.W., Keefe, L., Newman, P. and Day, A.G. “Prophylactic pancreatic enzymes to reduce feeding tube occlusions.” Nutrition in Clinical Practice. Oct; 18(5): 398-401 (2003).
Cogen, R., Weinryb, J., Pomerantz, C. and Fenstemacher, P. “Complications of jejunostomy tube feeding in nursing facility patients.” American Journal Gastroenterology. 86(11): 1610-3 (1991).
Marcuard, SP. and Stegall, KS. “Unclogging feeding tubes with pancreatic enzyme.” Journal of Parenteral and Enteral Nutrition. 14, 198-200 (1990).
For more information:
Maureen L. Mulvihill, Ph.D./814-355-0003
www.ActuatedMedical.com
info@actuatedmedical.com
Jun 29, 2018 | Press Releases
BELLEFONTE, PA – Actuated Medical, Inc. (AMI) recently signed two regional U.S. distributors for the TubeClear system. Alamo Scientific, Inc. distributes the TubeClear system throughout Texas, Oklahoma, Kansas, Nebraska, Missouri, and Iowa. Clinical Technology, Inc. (CTI) distributes the system in Ohio, Western Pennsylvania, Kentucky, Indiana, Michigan, Illinois, Wisconsin, Minnesota, North Dakota and South Dakota.
“Clinical Technology, Inc. is excited to begin representation of the TubeClear system from Actuated Medical,” said Kent Krafft, vice president of CTI. “As the premier specialty distributor in the Midwest, CTI strives to provide our customers with solutions to their challenges, and feel strongly that TubeClear offers a unique and effective solution to the persistent problem of clogged enteral feeding tubes. The system also fits nicely with our enteral feeding product mix, and we look forward to educating our clinicians on the many advantages TubeClear has to offer.”
The TubeClear system is an FDA cleared medical device that uses patented mechanical motion technology to 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.
“At Alamo, we specialize in bringing innovative medical technologies to the market for improving healthcare,” said Todd Endersby, president of Alamo Scientific. “TubeClear is a great fit as an innovative solution to a common problem with feeding tubes. We’re excited to represent the device and partner with Actuated.”
“Partnering with Alamo and CTI expedites access of the TubeClear system to clinicians who need an effective tool to clear partially and fully clogged feeding tubes,” said Maureen L. Mulvihill, Ph.D., president and CEO of AMI. “These partnerships are very well aligned to our corporate goal of improving patient outcomes.”
Please contact Actuated Medical at 1-814-355-0003 x 117 to be connected with the regional distributor in your area.
About Alamo Scientific, Inc.
Alamo Scientific Inc. is one of the few specialty medical distributors located within Texas. We carry a full inventory on the items we sell and shipping times to our major markets are only 1 to 2 days. Founded in 2005, Alamo has quickly built a highly respected reputation with both device manufacturers and leading hospitals within our service geography.
For more information, please visit www.alamoscientific.com.
About Clinical Technology, Inc.
Clinical Technology Inc.(CTI) is a leading specialty distributor of medical products in the mid-western region of the United States. Today, CTI operates directly in thirteen states, is part of a national distribution alliance, and serves as master distributor capable of providing sales and distribution throughout the country. In addition, CTI maintains the infrastructure to facilitate a product from concept through the FDA approval process and into manufacturing and distribution.
For more information, please visit www.clinical-tech.com.
# # #
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 acquisition partnerships. Their devices solve unmet clinical needs in target markets e.g., GI, critical care and pediatrics. Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485 certified.
For more information, please visit http://www.actuatedmedical.com.
Jan 17, 2017 | Press Releases
Building on its strong foundation, Actuated Medical hires Sales Representatives for sales expansion of the TubeClear System
BELLEFONTE, PA – January 17, 2016 – Maureen L. Mulvihill, President and CEO of Actuated Medical, Inc.(AMI) announces the addition of 6 senior sales leaders to support the nationwide sales launch of the TubeClear® System. These sales leaders were formerly part of the top producers for a recently acquired medical device company. Repeatedly recognized for their performance, they have a proven track record of exceeding customer expectations and establishing relationships with key customer constituencies.
“I have the great confidence that these Sales Leaders. Not only will they assist healthcare organizations in more effectively and efficiently clearing clogs in feeding and decompression tubes, but they will also be able connect with clinicians to identify new clinical needs. We are always looking for the next device to develop that improves patient outcomes and these leaders will be our eyes and ears with our customers,” says Mulvihill.
Using patented technology platforms, AMI develops medical devices that have unmet clinical needs in targeted markets. AMI has multiple devices in development that have been funded using non-equity capital (e.g., Small Business Innovation Research (SBIR) funds). For each technology, the goal is to develop devices for acquisition by a strategic buyer or private equity group. AMI’s first product, the TubeClear System is already FDA cleared and is building sales revenue to attract a technology acquisition.
The sales representatives along with Joseph Kroll, Director Clinical Education, will support TubeClear System customers nationwide. “These sales leaders understand the challenges faced by the nursing staff and nutritional support specialists. They are passionate about not only expanding the TubeClear System’s usage, but also about improving patient outcomes,” says Kroll.
About Actuated Medical, Inc.
Actuated Medical Inc. is committed to improving patient outcomes by designing the next generation of innovative and advanced medical devices through continuous improvement and innovative solutions.
US-based 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.
Dec 7, 2016 | Press Releases
TubeClear System cleared for Smaller Feeding and Decompression Tubes
BELLEFONTE, PA – December 7, 2016 – Actuated Medical Inc. (AMI) received U.S. Food and Drug Administration (FDA) Clearance on 3 additional TubeClear System Clearing Stem Models. This FDA clearance enables the TubeClear System to operate in feeding tubes as narrow as 6 French (2mm), which expands the capability of the TubeClear System to gastrostomy (G), jejunostromy (J) and nasoenteral (NE) 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.
Maureen L. Mulvihill, AMI’s President and CEO stated that, “We are excited by the additional FDA clearance. The ability to clear clogs in smaller diameter feeding tubes opens new US and international markets. It also enables paramedics to potentially clear clogged tubes in the patient’s home avoiding transportation and hospital readmission costs.”
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% rate (~1.7million 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 greater 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, Inc. in the United States. To learn more about the TubeClear System, additional information can be found at tubeclear.com.
About Actuated Medical, Inc.
Actuated Medical Inc. is committed to improving patient outcomes by designing the next generation of innovative and advanced medical devices through continuous improvement and innovative solutions.
US-based 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. For additional information, please visit www.actuatedmedical.com.
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