FDAnews Device Daily Bulletin
Medical Devices / Commercial Operations

Nipro Launches Elisio Polynephron Dialyzer in the U.S.

Feb. 11, 2014

Nipro Medical has launched its Elisio single-use, high-flux, hollow-fiber dialyzer in the U.S. renal market, following receipt of 510(k) clearance from the FDA.

The dialyzer’s Polynephron membrane functions like a human kidney, allowing for better clearance performance, the company says. The membrane contains thousands of fibers, each of which acts like a nephron, the functional unit of the kidney, purifying and filtering blood like the kidney does. The nephrons in the dialyzer have a 3D chemical structure with hydrophilic and hydrophobic domains, and the pore-spinning technology creates more homogeneous pore sizes to enable optimal sieving.

According to the Miami, Fla., devicemaker, Elisio’s design optimizes blood flow and prevents residual blood from remaining in the device. The contact between the diasylate and blood compartments provides high package density, and the redesigned caps and header shape are meant to optimize blood flow dynamics, the company says.

Elisio’s superior clearance performance for small and middle molecules has been demonstrated by both in vitro and in vivo testing, Nipro Medical says. It is available in sizes from 90H to 250H. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.