PRESS RELEASE
For Immediate Release

For More Information:


Subject: CombiSet True Flow™ Series bloodlines
Contact: Mark L. Costanzo
Vice President, Sales and Marketing
Fresenius Medical Care, NA
Toll-free 800-662-1237
mark.costanzo@fmc-na.com

Fresenius Medical Care, NA the world's leader in kidney dialysis has announced the newest advance in consistent blood flow rates during dialysis with its new CombiSet True Flow™ Series hemodialysis blood tubing.

Lexington, MA, October 30, 2002 - With CombiSet True Flow™ Series, the blood flow rate runs True from the beginning to the end of the dialysis treatment. This new development in bloodline technology is the result of extensive polymer research, in conjunction with precise manufacturing process control. The new bloodlines will be introduced to physicians at the ASN National Meeting in Philadelphia on November 1.

Dr. Jeffrey J. Sands, Vice President of Medical Technologies, Fresenius Medical Care, NA, commented on the importance of this advance. "Accurate blood flow delivery directly influences the quality of the hemodialysis treatment. Decreases in delivered blood flow can result in a reduction in kt/v urea or URR (common indicators of the amount of therapy delivered). The new CombiSet True Flow™ Series tubing will improve patient care by eliminating one potential source of decreased blood flow, helping to assure that the prescribed therapy is actually delivered."

A recent clinical study demonstrated the excellent performance of CombiSet True Flow™ Series. The clinical study of 20 patients showed that the actual delivered blood flow rate at the end of treatment was within 1.28 % of the prescribed blood flow using an ultrasound flow meter (HD02 Transonics, Inc. Ithica, NY). This was despite increasing negative pre pump arterial pressure, a known factor in decreased delivered blood flow. Treatment blood flow rates ranged from 200-500 ml/min with pre pump arterial pressures in the range of negative 110-285 mmHg over a four hour treatment.

During hemodialysis, blood is pumped using a peristaltic pump that utilizes rollers to compress the tubing and push the blood forward. If the elastic performance of the tubing degrades over time then the amount of blood pumped will be reduced. During a single hemodialysis treatment the blood tubing may be required to pump over 100 liters of blood. The innovative materials used in the CombiSet True Flow™ Series tubing were specifically designed to prevent this decrease in blood flow rate over time.

The accurate and consistent blood flow delivered by a bloodline can depend on a variety of factors. As a dialysis service provider and manufacturer of dialysis products, Fresenius Medical Care, NA, pays careful attention to those factors. Fresenius operates dialysis clinics throughout the US and manufactures products for the dialysis treatment, including hemodialysis equipment and dialyzers. CombiSet True Flow™ Series bloodlines are one important component in a product line that has led the industry in providing high quality treatments for hemodialysis patients.

Other key features of CombiSet True Flow blood tubing include:

  • size-matched line components that do not require bushings, and provide a smooth transition of blood through the extracorporeal circuit, resulting in lower resistance and maximized laminar flow.
  • Viral-retentive transducer protector to protect patients and staff from cross contamination.
  • A high degree of kink-resistance in the blood tubing and thicker walls provide increased protection against potential hemolytic incidents secondary to line kinks, without compromising ease of use.

For more information on CombiSet True Flow™ Series bloodlines, visit our website at
www.combi-set.com

The CombiSet True Flow™ Series hemodialysis blood tubing is currently being shipped to customers for commercial use in the US.