NEWS 2

Reprinted by permission of the News & Observer, Raleigh

Device Gets Long-Awaited OK

Former cancer patient's company may take off with an invention born of necessity
 

ANNE KRISHNAN, Staff Writer

Chapel Hill, North Carolina
June 20, 2006

The success of Carol Walborn's Chapel Hill business depends on more than supply and demand. It also requires government reimbursement. Walborn, a 59-year-old, first-time entrepreneur, has built a small medical supply company called For Patients around the patent-pending CathSling, a device designed to help safeguard the tubes that doctors implant in patients receiving long-term treatment. There's a medical need for the product, Walborn said, but it's also important that Medicare pay for the devices. She estimates that 50 percent to 75 percent of the critically ill patients who could use CathSlings depend on the government for their medical coverage.

The need was clear to Walborn, a cancer survivor who developed CathSling prototypes while receiving chemotherapy. Catheters and their attached IV tubes eliminate the need to stick patients for new IVs, but they create problems in patients' daily lives. "With some of the catheters that are longer ... you just have this thing hanging out of your chest, and what do you do with it?" said Jennifer Loftis, clinical operations director for Duke University Medical Center's adult bone-marrow transplant unit. "The women tucked them into their bras, but the men had them dangling under their shirts."

The danger is that the IV tubes will catch on clothes or furniture. Their constant weight and the frequent manipulation by nurses pull on the implantation site and compromise the sterile dressing over the site, Walborn said. And that can lead to infections. The Centers for Disease Control and Prevention reported in 2002 that it costs an average of $25,000 to treat each of the 250,000 catheter-related infections in the United States every year. "Most hospitals are really looking hard at this issue," she said.

The CathSling makes things easier by securing and protecting the catheter tubes, much like a sling for a broken arm, Loftis said. The product is simple: a fabric necklace made of a 1-inch-wide strip of gauze-like material, with a velcro pocket that grips the catheter's plastic tubing. The sling keeps the tubes stable while nurses manipulate them, and any tugging gets transferred to the fabric necklace, not the incision site.

Walborn filed her application with Medicare at the end of July and heard in November that the device had been approved for reimbursement.

CathSlings are intended to be distributed by hospitals and home-care agencies as part of catheter maintenance. The company has had one major sale so far: Duke's bone-marrow transplant unit. She expects medical centers to be much more receptive to the CathSling now that Medicare has promised to pay for it. "It is the one thing we need to get our foot in the door," she said. "They'll say no or yes, depending on whether it's reimbursed."
 

Medicare approval also is the first step toward coverage from private insurance companies, Walborn said. Other insurers often follow suit when Medicare decides to reimburse.

But despite her regulatory success, Walborn knows the current market would be limited if the CathSling was only used for Hickman-type catheters used for chemotherapy, dialysis and some nutrition and heart monitoring therapies. For Patients is expanding the CathSling use with other types of catheters including PICCS and portacaths. Walborn also is developing a product that she said "has universal medical appeal in every emergency room and doctor's office." She declined to elaborate. "CathSling was my starting point," she said. "We have other devices with a much larger market potential."