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The product is an FDA-cleared medical device that uses patented mechanical motion technology to clear occlusions.
January 3, 2019
By: Business Wire
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 a U.S. Food and Drug Administration-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 percent,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. 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 began Nov. 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. 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. Its 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. References 1. 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. 2. 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).
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