Sanford Health and University of South Dakota Collaborate to Develop DCBs With Precise Drug Delivery for PAD Treatment

December 16, 2015—Sanford Health and the University of South Dakota (USD) announced that they are collaborating to develop more effective drug-coated balloons (DCBs) to treat peripheral artery disease. The two new devices, which can more precisely deliver drugs to specific arteries, are based on intellectual property jointly created by Sanford’s Patrick Kelly, MD, and USD’s Gopinath Mani, PhD.

Whereas traditional DCBs release drugs in a burst profile, demanding the use of more balloons and release of medicine to areas not in need of repair, the methods designed by Dr. Mani and Dr. Kelly use a special coating that can be tailored to time the release of medicine and prevent release of drug while tracking to the target site. They will also be designed to allow for treatment in multiple arterial segments.

One of the methods developed by Dr. Kelly and Dr. Mani uses dextran sulfate polymer to control the release of medicine and is outlined in a paper published online in July 2015 ahead of print in the Journal of Biomedical Materials Research Part B: Applied Biomaterial. The other method accomplishes a controlled release with a polyethylene oxide coating that is applied to the balloon. Its success was demonstrated in a paper that published online in September ahead of print in the January 2016 edition of Acta Biomaterialia (2016;29:333–351).

In the announcement, Dr. Kelly commented, “This time-released method of delivering drugs via balloons is economical and may reduce the amount of unneeded chemotherapeutic agent that enters the body. If this technology works the way we think it will, we may also be able to use fewer of these costly balloons.” Dr. Kelly is a clinical research scientist with Sanford Research and he is a board-certified and fellowship-trained vascular and general surgeon. He holds dozens of patents and patent applications for medical devices and has run several clinical trials.

Dr. Mani added, “Our technology uses novel polymeric biomaterials to tailor the drug release in such a way that the drug will be delivered only at the treatment site without any drug loss in the blood stream. We are very excited that this technology provides the right platform to develop next-generation DCBs. These balloons are expected to provide an effective treatment and improve the quality of life of patients.” Dr. Mani is an assistant professor in USD’s biomedical engineering program. He has published more than 25 peer-reviewed research articles and currently has four patents pending on next-generation cardiovascular medical devices, noted Sanford Research and USD in the announcement.