Developing fit-for-purpose medical devices for critically ill newborns and children
Media Release: Hydrix on November 23, 2021
Categories: Cardiovascular technology, MedTech products, Navi Medical Technology,
The photo on the right shows Nash, together with his parents Jacinta and Travis.
Nash was born at just 28 weeks gestation age, weighed 738 grams, and was in a NICU (Neonatal Intensive Care Unit) for 10 weeks. To help ensure his survival, Nash, like many newborns and children in intensive care required the insertion of a thin, flexible tube called a Central Venous Catheter (CVC) into the umbilical stump to deliver potentially lifesaving medications and nutrients.
According to the World Health Organisation, there are nearly 30 million babies born each year that require critical care, and like Nash, many of these infants require central lines inserted into blood vessels to receive vital medications and nutrients.
The challenge with inserting CVCs into such small bodies is that up to 40% are misplaced when initially inserted, and up to 50% can migrate to a dangerous location within a few hours of insertion. This exposes the tiny patient to potentially devastating complications, affects clinical workflow, and can significantly add to the cost of hospitalisation to treat the adverse outcome.
Adding to the challenge, it may be surprising to learn that only around 15% of pediatric medical devices approved by the US FDA seek an indication for use in newborn patients. This means that less than 5% of all FDA approved medical devices are appropriate for use in newborns. It also forces pediatric clinicians to often ‘make do’ with devices and equipment designed for adults or larger patients and consequently not optimised for the care of critically ill newborns.
To help children like Nash, medical device company Navi Medical Technologies, together with development input from Hydrix, is developing the Neonav®, an ECG Tip Location System that provides real-time guidance to clinical staff during CVC insertion, which can also be used to reconfirm safe positioning for ongoing use. Critically, this can be achieved without disturbing the sterile field, enabling significant cost-savings.
Nash, born at 28 weeks gestation age, benefited from
prototype Neonav®, technology.
Breakthrough technology
Navi’s novel technology works by measuring ECG signals from the heart via a saline column in an Umbilical Venous Catheter. A proprietary algorithm identifies the location of the catheter tip and communicates this to medical staff via a display. This functionality not only better enables initial catheter placement but also improves the process for assessing catheter migration within the patient days after the initial placement.
“For far too long, pediatric specialists have been manipulating adult medical devices to create solutions for children’s bodies because it’s the only available option”
Washington, DC.
“Currently, clinical staff don’t know where the catheter tip is located inside the patient during a procedure,” says Associate Professor Christiane Theda, neonatologist at the Women Hospital and the Chief Medical Officer at Navi. “This can result in high instances of misplacement as well as further complications. The Neonav® ECG Tip Location System works a bit like a car’s parking sensor. It provides clinical staff with crucial real-time visual information on where the catheter is located within the patient by analysing ECG signals within the body. This helps avoid misplacement and ultimately allows for faster drug delivery and better patient outcomes.”
To progress the technology, the Navi and Hydrix teams have spent many days in neonatal & pediatric intensive care units, observing lifesaving procedures first hand, talking to clinical staff to gain a deeper understanding of the challenges they face on a daily basis, while brainstorming innovative solutions to the engineering problems. Arising from these insights, an early clinical prototype was developed and used in over 80 critically ill newborns at the Royal Women’s Hospital (Melbourne) as part of a feasibility study. This observational phase of the clinical study enabled neonatologists to collect intravascular ECG data from 50 newborn subjects undergoing Umbilical Venous Catheter procedures.
Where to from here?
Navi is currently developing an advanced prototype of the device with the help of a recently received Victorian Government Grant (Technology Adoption and Innovation Program), enabling Navi’s Neonav® device to reach a critical stage of product development maturity.
In commenting on their technology development journey so far, Navi co-founder and chief executive Alex Newton said “Less than 5 per cent of medical innovations that make it to market have a neonatal indication for use – there’s a huge market for products like the Neonav® to assist in delivering the care critically ill newborns need.”
“At Navi, we’re committed to dedicating all of our efforts to develop a medical device that clinical staff really need. We are continuously looking to expand our network of partners who would be interested in joining our cause to solve this important clinical problem for our most vulnerable patients. ”