## [Transonic Systems, Inc.]{.underline}

**\> \>**Cornelis J. Drost, President, Transonic Systems

**\> \>**34 Dutch Mill Road

**\> \>** Ithaca, NY 14850

**\> Phone:** 607-257-5300 **Fax:** 607-257-7256 **FF\> \> \> \>
Email:** <cor@transonic.com>

**\> \> Website:** [http://www.transonic.com](http://www.transonic.com/)

**Project Title:** Transonic HD01 Hemodialysis Flow Monitor

**Technology Developed**

*[The success:]{.underline}* SBIR Phase-I and -II funding allowed
Transonic Systems, Inc. to develop and validate a device that will
measurably improve the health of 210,000 American kidney failure
patients receiving hemodialysis, and may potentially save Medicare and
other insurers an estimated \$0.9 billion dollars/year.

*[The health problem:]{.underline}* SBIR funding allowed Transonic
Systems, Inc. - a business dedicated to engineering, manufacturing, and
marketing innovative clinical and research blood flow measurement
devices - to develop, validate and gain clinical acceptance of a
pioneering new method and device that diagnoses the health of the
dialysis "shunt" (a surgically-created connection between an artery and
a vein) in kidney failure patients undergoing hemodialysis. Patients
suffering from kidney failure -- formally known as End-Stage Renal
Disease (ESRD) - typically receive three hemodialysis treatments of
their blood each week. These treatments remove toxins and liquids
normally removed by the kidneys. The patient is dialyzed by connecting
the patient's cardiovascular circuit to the dialysis machine via needles
inserted into the patient's shunt, thus making the shunt the critical
connection for removing blood and returning filtered blood to the
patient's cardiovascular system. This shunt is the patient's link to
life: without a well-functioning shunt a patient cannot receive adequate
dialysis. Unfortunately, shunts tend to develop a progressive disease
called stenosis, meaning that the shunt gradually blocks up. When the
stenosis progresses to the point where the shunt flow is less than the
flow drawn by the dialysis machine, then patient will become
under-dialyzed and become sick, since the dialyzer will recirculate
freshly dialyzed blood rather than process the patient's entire blood
supply. If stenosis is allowed to progress even further, full thrombosis
(blockage) of the shunt occurs, which then requires traumatic and
expensive surgery to clear the blockage or surgically replace the graft.
However, if the access stenosis is detected early enough, then the
disease can be reversed by a minimally invasive procedure such as
angioplasty.

*[The Transonic Systems approach to measuring access flow:]{.underline}*
Clinical studies done in the early 1990s indicated that a drop in shunt
flow is a reliable warning of the onset of access stenosis; if caught in
time this disease can be reversed by minimally-invasive procedures such
as angioplasty. At that time the only available testing method was Color
Doppler Ultrasound; this method was costly (because it is an expensive
device, and its measurements requires a medical specialist and a
separate office visit) and inaccurate (because of turbulent flow
conditions normally seen in the shunt.)

Supported by NIH SBIR funding, Transonic pioneered a new method for
measuring shunt flow called ultrasound indicator dilution. This method
uses special clip-on ultrasonic sensors attached to arterial and venous
dialysis tubing lines. These sensors measure both volume blood flow in
the dialysis circuit, as well as indicator dilution changes in blood
ultrasonic velocity caused by small saline injections. Under Transonic's
novel shunt flow measurement protocol, the patient's dialysis blood
lines are temporarily reversed so the dialyzer pump returns the patient
blood into the shunt, upstream from its intake line. A bolus of saline
is then introduced in the upstream dialysis line; the sensor on that
blood line registers the initial saline concentration. After mixing in
the shunt, the downstream intake line samples the saline concentration,
and the ultrasonic sensor placed on the downstream dialysis line
registers the indicator dilution curve resulting from the saline
injections. The shunt flow is then calculated by processing and
analyzing the upstream and downstream indicator dilution curves.

In developing this technology, the Transonic SBIR project team worked
closely with prominent Nephrology researchers to validate the clinical
significance in their research. This collaboration also helped Transonic
develop software that made the technique and the Transonic device (the
"HD01 Hemodialysis Monitor") robust and simple to use. The result was an
FDA-cleared, compact, and inexpensive device and measurement protocol
that will work with any manufacturer's hemodialysis machine and indeed
can be performed by a technician after only one day of in-service
training. Once trained, the technician can perform a full patient
diagnostic test in 15 - 20 minutes.

**Uses of Technology:**

Because of the HD01 Hemodialysis Monitor's simplicity, practicality and
effectiveness, it has been estimated that the average hemodialysis
patient may spend 10 fewer/days/year in the hospital due to
hemodialysis-related complications. The cost of access morbidity was
approximately \$7,871/year/patient in 1994 (Hakim *et al.,* 1998), and
for 1999 it is estimated to be \$8,800/year/patient. It is estimated
that HD01 monitoring can reduce these costs by approximately 50%. With
more than 210,000 hemodialysis patients in the U.S. alone, Medicare and
other insurance providers can save \$0.92 billion/year. Since Medicare
pays for the care of over 90% of U.S. hemodialysis patients, U.S.
taxpayers will therefore benefit from most of these savings.
[Recognizing the benefits to patient health and the cost savings to
Medicare & other insurers, the CPT Editorial Panel of the American
Medical Association has approved a new Medicare reimbursement code for
monitoring the blood flow in grafts during hemodialysis. This code will
become effective on Jan. 1, 2001.]{.mark}

##### Global Acceptance of SBIR/STTR-developed technology

The clinical studies spearheaded under this SBIR project (and continued
by the Nephrology community) have fueled a world-wide change in
hemodialysis patient monitoring procedures. At this writing researchers
have published 95 papers and abstracts on this new technology, and the
Transonic HD01 method is now listed as a preferred measurement approach
in the National Kidney Foundation's 1997 "Dialysis Outcome Quality
Initiative". The HD01 Hemodialysis Monitor is now being used in
approximately 7% of the USA clinics (with further sales strongly
depending on new Medicare reimbursement policy). Device acceptance in
countries with socialized medicine has been even more dramatic: 25% of
the dialysis clinics in Canada, 35% of the clinics in France, and 70% of
the clinics in Holland use the Transonic HD01 in their scheduled patient
care. And a final note: US News & World Reports (July 17, 2000)
published a list of 50 Best Hospitals for Kidney Disease in the USA.
Half of these hospitals use the Transonic HD01!

**[For More Information on the Transonic Systems HD01 & Flow Quality
Control:]{.underline}**

  --------------------------------------- ----------------------------------------------
  Pictures of the HD01 Hemodialysis       <http://www.transonic.com/hd01_monitor.html>
  Monitor                                 

  Transonic Web Page on Hemodialysis      <http://www.transonic.com/hemodialysis.html>
  Quality Control                         

  Caring for a patient's hemodialysis     <http://www.springnet.com/ce/p003b.htm>
  shunt (access)                          
  --------------------------------------- ----------------------------------------------

**[For Touching & Compelling Descriptions of Life on
Dialysis]{.underline}**

  ----------------------------- -------------------------------------------------------------
  A woman's experience with     <http://www.geocities.com/HotSprings/Falls/7375/index.html>
  hemodialysis                  

  A man's experience with       <http://www.cc.utah.edu/~cla6202/DrF.htm>
  hemodialysis                  

  A child's experience with     <http://members.tripod.lycos.co.kr/jaihyuk/index1.html>
  hemodialysis                  
  ----------------------------- -------------------------------------------------------------

**National Institutes of Health Awards**

R44 DK50499