Jul 16, 2021

Medtronic Secures FDA Clearance For First Ever Infusion Set That Can Be Worn Up To 7 Days By People With Diabetes

Medtronic plc (NYSE:MDT), the global leader in medical technology, today received U.S. Food and Drug Administration (FDA) 510(K) clearance on the first and only...

DUBLIN – July 16, 2021 – Medtronic plc (NYSE:MDT), the global leader in medical technology, today received U.S. Food and Drug Administration (FDA) 510(K) clearance on the first and only insulin pump infusion set that can be worn for up to seven days. An infusion set is tubing that delivers insulin from the pump to the body and typically requires a set change every two to three days.

This innovation more than doubles the length of time an infusion set can be worn so individuals managing their diabetes can safely stay on insulin pump therapy with fewer interruptions and insertions1 while experiencing enhanced convenience and comfort2* to their diabetes management routine.

"This first-of-its kind infusion set innovation introduces an exciting shift in the experience for people with diabetes — extending wear time so people can think less about changing out their sets, and, in turn, reducing burden in a meaningful way," said Bob Vigersky, chief medical officer, Medtronic Diabetes Business. “This is an area that doesn’t receive as much focus but is a very big component for pump users that impacts the overall experience and can help make living with diabetes easier.”

In June 2021, Medtronic presented the pivotal trial results that included data on both safety and patient satisfaction when using the Medtronic Extended infusion set at the 81st American Diabetes Association Scientific Sessions. The data demonstrated that the extended-wear infusion set that lasts up to seven days was safe and had high patient satisfaction. Overall, patients preferred the longer-wear set, rating it higher on ease of insertion, comfort of wear, duration of wear, time required to change infusion set and convenience.

The Medtronic Extended infusion set, which is designed and manufactured in collaboration with Unomedical, leverages advanced materials that help reduce insulin preservative loss and maintains insulin flow and stability. The new tubing connector improves the physical and chemical stability of insulin3, increases the reliability of infusion site performance4,5, and reduces the risk of infusion set occlusion1. The newly developed adhesive patch has an adhesive layer that extends wear time and provides comfort2 and durability for up to seven days.

“We’re thrilled to lead the way on this exciting new innovation — the first meaningful change to be introduced to the infusion set experience in two decades,” said Ali Dianaty, vice president, product innovation, Medtronic Diabetes Business. “Our commitment to enhancing the customer experience is unwavering and we’re pleased to set the course for advancements with the introduction of many first-of-its-kind technologies: the first system to integrate insulin pumps and continuous glucose monitors (CGM), the first technology to suspend insulin delivery and reduce severe lows, the first Smart Insulin Pen, the first system to automatically adjust background insulin, the first stand-alone CGM with predictive alerts, and now the first extended infusion set for up to seven days of wear. With each of these advancements and the firsts that we’ve introduced, we’re simplifying diabetes management with innovation that truly matters for our customers.”

Medtronic is partnering closely with Unomedical to make the Medtronic Extended infusion set commercially available in the United States in 2022 to ensure a seamless customer transition, experience, and product availability.  

About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)

Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in approximately 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

About Unomedical
Unomedical is a subsidiary of ConvaTec plc. ConvaTec is a FTSE-listed global medical products and technologies company focused on therapies for the management of chronic conditions, with leading market positions in advanced wound care, ostomy care, continence care and infusion care.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 Ilany et al. Clinical study of a new extended wear infusion set design. Poster presented at 13th International Conference on Advanced Technologies & Treatments for Diabetes; 2020 February 19-22, Madrid, Spain.
2 Brazg et al. Reported Satisfaction during the Medtronic Extended-Wear Infusion Set (EWIS) Pivotal Trial. Diabetes Jun 2021, 70 (Supplement 1) 101-LB; DOI: 10.2337/db21-101-LB.
3 Zhang JY, et al. Advances in Insulin Pump Infusion Sets Symposium Report. Journal of Diabetes Science and Technology 2021; DOI: 10.1177/1932296821999080.
4 Chattaraj S, et al. The Medtronic extended-wear infusion set: Determining mechanisms of action. Diabetes Technology & Therapeutics. Jun 2021.A-1-A-206.
5 Chattaraj S, et al. Study of insulin stability impact on pump therapy: Test model development. Diabetes. 2020;69 (Supplement 1):1012-P
*When compared with two to three-day infusions sets.