Medical Device Daily

Gambro Renal Products (Lakewood, Colorado) said it has developed a “high-flux, steam sterilized pediatric dialyzer,“ which it called the first to be marketed in the U.S. under a 510(k) clearance from the FDA.

The Polyflux 6H dialyzer is designed for small patients, including children.

“The Polyflux H takes into account the many complexities of pediatric chronic hemodialysis, such as patient age and weight, the size of the dialyzer and the biocompatibility of the dialyzer,“ the company said.

Marketing Manager Helene Olefsky told Medical Device Daily that the “primary difference“ between the Polyflux 6H and adult dialyzers is the size of the unit that acts as the artificial kidney. Whereas the so-called “surface area“ of a dialyzer in the Polyflux family for adult patients would be about a 1.4 square meter surface area, the Polyflux 6H is about 0.6 meters square in surface area.

“Gambro is very excited about bringing this new product to the pediatric market,“ Olefsky said in a prepared statement. “It provides all of the benefits of Polyflux high-flux dialyzers for use in a pediatric application.“

The Polyflux H family comes in three sizes, with 1.4 being the smallest, she said.

“But [the Polyflux 6H dialyzer] has the same fiber configuration, meaning the fiber is undulated, or wavy, to produce better clearances for the patient,“ Olefsky told MDD, explaining that clearance refers to the cleansing of toxins from the blood in those patients with end-stage renal disease, often a complication of both Type 1 and Type 2 diabetes.

Both adult patients and pediatric patients are dialyzed about three times a week for about four hours each visit, she said. But whereas most adult dialysis patients are treated at freestanding chronic dialysis centers, children most often are treated within hospital-based units, she said.

While Gambro has had pediatric dialyzers in the past, she said they were not made out of the same material, which involves the type of fiber of which the dialyzer is made.

“It is also more biocompatible, meaning more compatible for the patient, and the patient does not have reactions like they could have with other fibers,“ Olefsky said.

Another important feature – and one of its biggest competitive advantages currently, she said – is that the new pediatric dialyzer is steam-sterilized, which, “according to all the literature, [is] the safest sterilization method. None of our competitors right now use steam.“

Among the top three global competitors in dialysis equipment are Fresenius Medical Care (Bad Homburg, Germany) and Baxter Healthcare (Deerfield, Illinois). Together, according to Gambro, those three companies comprise two-thirds of the global market.

The Polyflux 6H dialyzer is compatible with all Phoenix dialysis systems. About 1% of ESRD patients are younger than 20 years old. With the ESRD patients estimated at 350,000, that would put pediatric patients at about 3,500. Pediatric dialysis patients have a low incidence of ESRD, and many receive transplants, decreasing the overall population size, Gambro said.

Olefsky said Gambro would market the devices wherever people are being treated, whether that is in clinics or in hospitals.

A marketing acceptance study will be conducted with Dr. Stuart Goldstein at Texas Children's Hospital beginning this month. The study will explore the use of the product for the first time in the U.S., the company said.

Gambro plans to formally launch the Polyflux 6H dialyzer to the U.S. nephrology community at the American Nephrology Nurses Association (Pitman, New Jersey) conference in Nashville, Tennessee, April 2-5.

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