US Food and Drug Administration grants dialysis system incorporating U of T technology breakthrough device designation

Endexo®, polymer comprised of surface modifying molecules, incorporated into a system that may prevent blood clots in patients undergoing dialysis 

Fresenius Medical Care North America’s new hemodialysis system, incorporating a U of T technology called Endexo®, has been granted breakthrough device designation by the US Food and Drug Administration. An antithrombogenic additive, Endexo® — first developed in the labs of Paul Santerre, professor at the Faculty of Dentistry, cross appointed to the Institute of Biomaterials and Biomedical Engineering and commercialized through health technology start-up Interface Biologics, Inc. — may help prevent blood clots during dialysis when added to blood lines and hemodialyzers.

The breakthrough device designation is part of a new program started at the FDA to move lifesaving and critical technologies through its rigorous approvals process more quickly. Currently, patients who undergo dialysis are often prescribed anticoagulants. The new dialysis system would contribute in an important way to managing the need for these drugs, which can have significant side effects. 

"Receiving this designation, we are right on track with a new dialysis system that will directly benefit our patients' well-being," said Dr. Olaf Schermeier, chief executive officer for global research and development at Fresenius Medical Care, in a statement released to media.

If successful in receiving FDA approval, the Fresenius system is poised to make a massive impact on the health and wellbeing of those living with renal failure. According to 2016 statistics from the National Kidney Network, up to 37 million people in the US live with chronic kidney failure, with more than 500,000 of those patients receiving dialysis at least 3 times per week. 

“This is more evidence that U of T science and engineering research in the biomaterials field is changing lives,” said Santerre, who also holds the Baxter Chair for Health Technology and Commercialization, UHN-Techna, and is appointed to the Translational Biology and Engineering Program at the Ted Rogers Centre for Heart Research.

Fresenius Medical Care holds the exclusive worldwide license to apply the Endexo® technology to its dialysis health technologies. 

Photo: Jeff Comber