Lineus Medical’s SafeBreak Vascular product has been chosen by the nonprofit foundation New England Pediatrics Device Consortium for a $50,000 grant to fund the development of solutions to the issue of IV catheter dislodgment for pediatric patients.
The Fayetteville company’s SafeBreak product attaches to an IV line, and when force is applied to the line the two pieces break away from each other, creating “a controlled separation,” preventing damage to the IV line and not requiring the insertion of a new one, according to its website.
SafeBreak is on track for commercialization during the first quarter of 2018, pending approval from the U.S. Food & Drug Administration, said founder and CEO Spencer Jones. However, it is not confirmed at this time that the product, designed for adults, can be used as-is — without modification — for children.
It’s a matter of striking the right balance when it comes to the force it takes to make the line separate. If SafeBreak holds too strong, it won’t work properly and the IV will be pulled out when force is applied. Lineus Medical’s lab testing shows an IV line can be negatively impacted with about 4.3 pounds of force, so the version of SafeBreak is designed to separate when a force of more than 3.7 pounds is applied across a line, according to the site.
Lineus Medical said hospital patients are given an IV between 60% and 90% of the time, and the website quotes the Journal of Infusion Nursing as saying IVs have a 46% failure rate.
Lineus Medical was one of three companies given the award by NEPDC, and the total amount given was $100,000. CareAline Products of Danvers, Mass., was chosen for its CareAline CVC Wrap and PICC Sleeve and Gus Gear of Pittsburg was chosen for its product, Central Line Wraps, according to a press release from NEPDC.
“In the primary care setting, when I see families trying to manage long-term health issues with their kids, we try to look for areas of light. At times the tunnel looks pretty dark,” Dr. Marion Pierson, pediatrician at Village Pediatrics and NEPDC adviser, said in the press release. “Having to recapture ground when IV access lines are lost or tubes become dislodged can be like traveling backwards in that long, dark tunnel.”
Institutions within the NEPDC are MassGeneral Hospital for Children at Massachusetts General Hospital, Dartmouth-Hitchcock Children’s Hospital at Dartmouth, the Dartmouth Institute for Health Policy & Clinical Practice, the Institute for Pediatric Innovation, Consortia for Improving Medicine with Innovation & Technology and the product development company Simbex.
NEW BOARD MEMBERS
Lineus Medical also made additions to its Technical Advisory Board within the past few months. Lineus Medical said the new members are “vascular access stalwarts.”
Darcy Doellman is a pediatric vascular access specialist and past president of the Association for Vascular Access, according to a LIneus Medical press release. Matt Stuckert is vice president of sales for Magnolia Medical and vascular access market veteran, according to the release.
In September, Lineus Medical announced the conclusion of a Series A funding round of $1.365 million. Since the company’s 2015 founding, Jones and his team have raised $2.215 million. Vance Clement serves as chief operations officer for Lineus Medical, and Jordan Mykleby serves as director of engineering. Jones invented SafeBreak while working as an overnight nurse at CHI St. Vincent Hospital in Little Rock in 2015. Jones purchased an existing patent for the SafeBreak IV, refined the device and has been working since 2015 to bring it to market.