NxStage Medical gets FDA clearance for home hemodialysis therapy device

By Elaine Rigoli

Tampa, Fla., April 12 - NxStage Medical, Inc. has received Food and Drug Administration 510(k) clearance to market its PureFlow SL product and for its first clinical use.

The device prepares high-purity dialysate, which exceeds dialysis industry standards for purity, from ordinary tap water in the dialysis patient's home, according to a news release.

This product is designed to help patients with end-stage renal disease more conveniently and effectively manage their home hemodialysis therapy by eliminating the need for bagged fluids, the release said.

"The PureFlow SL helps NxStage and our partners achieve a core objective - making home hemodialysis therapy even more practical for all patients who might benefit. We are very pleased the FDA has cleared this novel technology and we look forward to its potential to improve quality of life and ease of use for patients performing home hemodialysis with the NxStage System One," said Jeff Burbank, president and chief executive officer, in a statement.

"Initial patients began using the system this week, and we continue to be on track for a broad commercial release in July 2006," he added.

NxStage, headquartered in Lawrence, Mass., develops, manufactures and markets systems for the treatment of end-stage renal disease and acute kidney failure.

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