UNC Hospitals is one of first medical centers to use new device for treating life-threatening kidney problem

Oct. 25, 2004

UNC Hospitals is one of first medical centers to use new device for treating life-threatening kidney problem

CHAPEL HILL, N.C. – The University of North Carolina Hospitals is one of only 10 medical centers worldwide so far that have used a new device approved in January for treating a life-threatening kidney problem.

The device is called the Benephit Infusion System. It was developed by FlowMedica Inc. of Fremont, Calif., to provide a safer, more effective way of treating a type of acute kidney failure that sometimes occurs in patients undergoing procedures such as a cardiac catheterization.

“This is a promising technology that will allow us to give protective drugs directly into the kidneys, minimizing unwanted systemic side effects,” said Dr. Mauricio Cohen, an interventional cardiologist at the UNC Heart Center and an assistant professor in the UNC School of Medicine.

In particular, the Benephit Infusion System was developed to treat patients at risk of developing a condition called radiocontrast nephropathy, or RCN. RCN is a common cause of kidney failure in patients undergoing interventional and diagnostic cardiac catheterization.

Radiocontrast dyes are used during cardiac procedures so that the flow of blood, and the locations of blockages, can be seen on a video monitor. RCN occurs when the kidneys of patients undergoing the procedures are unable to process these dyes. Nearly half a million patients a year undergoing cardiac catheterization in the United States are considered to be at risk for RCN, including those with diabetes, renal insufficiency and congestive heart failure.

It is believed that radiocontrast dyes can lead to RCN by constricting the renal arteries, which supply blood to the kidneys. When this happens, it can be treated by giving the patient drugs that dilate, or re-open, the renal arteries. But until recently these drugs could only be administered systemically, meaning they affected the patient’s entire vascular system. Systemic administration of the drugs can lead to life-threatening complications, such as a dangerous drop in blood pressure.

The Benephit Infusion System solves this problem by enabling a physician to deliver drugs directly to both renal arteries at the same time, without impacting the rest of the patient’s vascular system. The device is inserted in an artery in the patient’s groin and threaded from there to the site where the drugs are needed, and then the drugs are delivered. In addition, the Benephit system enables a physician to introduce two different catheters at the same time from a single access point in the groin. While one catheter is used to administer drugs, the other can be used to perform other catheter-based cardiac procedures.

FlowMedica demonstrated the first human use of the Benephit system at Heart Center Siegburg in Germany in 2003. The U.S. Food and Drug Administration gave approval in January 2004 for FlowMedica to market the system. In March, FlowMedica announced that physicians had launched a post-market clinical study of the system.

To date only nine medical centers in the United States have used the Benephit system. These are UNC Hospitals, the Scripps Clinic in La Jolla, Calif., St. Joseph's Medical Center in Stockton, Calif., Brigham and Women's Hospital in Boston, Lenox Hill Hospital and NewYork-Presbyterian Hospital, both in New York City; the Ochsner Clinic in New Orleans, the Brotman Medical Center in Culver City, Calif., and Memorial Hermann Hospital in Houston.

Note: Dr. Cohen is available for media interviews. To request an interview, contact Stephanie Crayton at (919) 966-2860 or scrayton@unch.unc.edu. 

An image of the Benephit Infusion System is available at http://www.unchealthcare.org/images/benephit.gif.

Media contact: Stephanie Crayton, (919) 966-2860, scrayton@unch.unc.edu