Advanced Stent Offers Better Care for Kidney Patients

Achievement date: 

Successful research on a biodegradable drug-releasing stentat the NSF-funded Engineering Research Center (ERC) for Revolutionizing Metallic Biomaterials (RMB), headquartered at North Carolina A&T University (NCAT), led to a new start-up company to help move it to market. With help from the Technology Commercialization Accelerator program at the University of Cincinnati (an RMB partner) and others, the stent team started a company called InoVasc, identified a trade name for the stent (Flo-Fluent), and is preparing commercialization grant applications. 


All of the 100,000 people in the U.S. who have arteriovenous fistula (AVF) stents placed each year are candidates for the new device, as are 20,000 additional patients whose small veins previously ruled out AVF stents. At $1,500 per stent, the market potential is estimated at $180 million per year, and annual cost savings to health care as a whole are estimated at $780 million. For example, more than 400,000 patients in the U.S., and over one million worldwide, undergo hemodialysis to clean out toxins their kidneys can no longer remove. Accessing the bloodstream is a critical part of the process, and AVF stents are preferred because they offer better long-term survival and lower infection risk than other methods.


Flo-Fluent is a biodegradable drug-eluting (releasing) stent placed into narrowed, diseased peripheral or coronary arteries that slowly releases a drug to block cell proliferation. The new stent is the culmination of research and successful testing.In a month-long in vivo experiment, the biodegradable stent demonstrated the ability to dilate and increase blood flow in the AVF with no observed negative response. Collaborative effort within RMB on the new stent included: incorporation of an anti-proliferation polymer coating and a novel magnesium (Mg) alloy; the experiment model; and design, simulation, and manufacturing technology. During testing, hydrogen sensors were used to measure degradation of the stent. The RMB has established intellectual property rights to most of the technologies involved in the new stent, and increased industrial interest in the technology is leading to new collaborations.