ivWatch Receives FDA 510 (k) Clearance to Advance Safety of IV Therapy in Pediatrics

The device's new indication allows for wide-scale implementation to help clinicians protect children from IV infiltration injury across the United States.

Hampton, VA, January, 5, 2017 –  Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400 for pediatric patients under the age of 18. The device is a continuous monitor for a patient’s IV and provides early detection of an infiltration– when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs (PIVs) are one of the most common invasive medical procedures performed with over 150 million IV catheters placed in the Unites States annually, yet current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations.[1]  The ivWatch Model 400 was developed to address this unmet need in healthcare.

“We continue to focus on improving patient safety and outcomes,” states Dr. Brian Clare, Chief Medical Officer at ivWatch. “We are excited to be able to offer the ivWatch Model 400 for pediatric patients to enable children’s hospitals and other facilities catering to pediatrics another measure of protection for the early detection of IV infiltration or extravasation events.”

Pediatric patients can be at high risk for infiltrations due to body size and movement. With several hundred pediatric hospitals in the United States alone, the ivWatch Model 400 represents a new option for pediatric medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors while improving outcomes.

The ivWatch Model 400 received FDA clearance for patients 18 years and older in February 2015 and most recently received FDA 510(k) clearance for patients 17 and under in December 2016.  The ivWatch Model 400 is backed by 16 years of research and development and includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of tissues.  The sensor is coupled to a highly intuitive pole-mounted patient monitor.  The device notifies clinicians if conditions suggest an infiltration, allowing them to address the issue early to reduce patient harm.

“We see this new indication as a milestone for the company. By addressing this gap in health care, we are addressing a need in the pediatric space by offering a solution that will reduce harm to children already faced with medical issues,” states John Lawson, President & CEO, W.M. Jordan Company and ivWatch board member.  “To offer this type of proven technology to children will further impact and improve patient safety and outcomes for this at risk population.”

“When we received our first FDA clearance, I stated our goal was to be on every IV pole in the country and provide continuous monitoring of every IV placed,” says Gary Warren, President & CEO of ivWatch.  “Our ability to offer our product to both adult and pediatric patients places us one step closer to that goal and solving this significant health care problem.”

To learn more about ivWatch and how to begin an evaluation of the ivWatch Model 400, call 1-855-489-2824, Option 1.

[1] R.E. Helm, J.D. Klausner, J.K.Klempeer, L.M.Flint, and E. Huang, “Accepted but Unacceptable: Peripheral IV Catheter Failure,” Journal of Infusion Nursing, Vol. 38, No. 3, May/June 2015, pp. 189-203

Erin Wendell
Mobile (757) 633-4688