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FDA Clears HD Monitor

Hemodialysis Adequacy & Access Patency Management

 

FEBRUARY, 1997 - The Federal Food and Drug Administration's (FDA) recent clearance to market The Transonic Hemodialysis Monitor revolutionizes dialysis patient management in the nation's 2,800 dialysis centers.

Hemodialysis patients depend on their vascular access shunts as their link to life. The vascular access is a surgically created shunt, or connection, between an artery and a vein in a patient's arm or leg. A prescribed high level of blood flow must pass through the shunt for effective dialysis. Shunts tend to occlude over time, necessitating expensive and traumatic access revision surgery to create a new open shunt. Eventually new shunt sites are not available and the patient cannot receive further hemodialysis. The constant strain of end-stage renal disease associated with failing dialysis, and coupled with the prospect of more surgery and costly treatment, lead many patients to give up hope.

With a small investment in time and cost, The Transonic Monitor allows the attending dialysis nurse to monitor, during a routine dialysis treatment, how well dialysis is being administered, so that patient care improvements can be implemented immediately. With the monitor, the nurse can also identify the early warning signs of flow obstruction in the hemodialysis access shunt, at a time when a minimally invasive flow restoration procedure can be effective in extending the life of the access. This translates into less patient trauma and surgery, and reduced treatment cost. In the past, diagnosis for such patients would only be undertaken after prolonged patient sickness when it was obvious that dialysis was not working. No longer will the attending dialysis nurse or nephrologist have to depend on information from prohibitively expensive ultrasound scanning or blood samples which have to be processed in a lab to learn about their patient's status. Rather, The Transonic Hemodialysis Monitor gives them immediate feedback on several parameters vital to successful dialysis.

Technology

Developed by Transonic Systems Inc., an Ithaca, NY based spin-off company from Cornell University, and a leading innovator in flow measurement technology, the "Krivitski method," named after the Company's senior scientist, combines two well -established methodologies: ultrasonic transit-time flow measurement and indicator dilution. The technology calls for ultrasonic transit-time sensors to be positioned on the dialysis tubing. Simple bolus injections of isotonic saline are used to measure vascular access flow and recirculation through the access. The sensors also directly measure blood line flow.

Since introduction of the Transonic Hemodialysis Monitor two years ago, more than 30 validation and clinical screening studies have been published by scientists in peer-reviewed journals. At conventions and meetings around the world, this breakthrough technology has been acclaimed by nephrologists. The National Institutes of Health (NIH) continues to underwrite their support for further refinements in the technology with a grant for $365,000 to Transonic Systems Inc. for fiscal 1997.

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