FDA News

FDA 510 Clearance of New Design of the Allient(R) Sorbent Hemodialysis System

(Oct 22, 2007)-- Renal Solutions, provider of advanced sorbent hemodialysis products and services for treatment of patients with renal failure, announced that it has received 510 clearance from the U.S. Food and Drug Administration (FDA) for its newly enhanced Allient Sorbent Hemodialysis System in chronic and acute hemodialysis applications. The new Allient System features improvements in ease of manufacturing, service and user-friendliness. In preparation for the Allient System commercialization, Renal Solutions is also launching its SMARRT (Sorbent Management for Advanced Renal Replacement Therapy) platform and campaign, which will introduce the benefits of advanced sorbent therapy to the renal community.

SMARRT therapy utilizes a gentle, patient-driven technology backed by over 6 million treatments. It enables short, standard or extended duration hemodialysis therapy using just 1.5 gallons (6 liters) of drinking water. The small dialysate quantity made possible by sorbent technology provides an inherent volume safety not possible with conventional hemodialysis technology. At the same time, it creates a dialysate flow rate of up to 400 ml/min., enabling the provision of highly effective dialysis. Advanced sorbent cartridges contain specialized sorbent compounds that regenerate fresh, high purity dialysate, eliminating the need for complex and costly water purification systems.

The Allient System will be the first dialysis system to bring SMARRT technology to the market, opening new treatment options to dialysis professionals and patients. The Allient System provides multiple treatment options without the need for an independent water purification system, batch production of dialysate, or large volumes of packaged sterile fluid. In addition to the sorbent cartridge benefits, the Allient System's revolutionary Pulsar(TM) Blood Pump provides expanded safety and versatility advantages as compared to conventional pumps. Through its unique, pressure-limited, two-chamber design, the Pulsar Pump enables both dual and single needle access. Pressure limitation, in combination with single needle access, provides added safety against vascular access disconnection, as well as a diminished risk of vascular access trauma.

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