Doctors can now measure the volumetric (milliliters/minute) flow changes caused by each angioplasty balloon expansion & therefore can repeat the angioplasty until the desired graft access flow is restored.

This is of great benefit to the hemodialysis patient, since an effective flow restoration procedure extends access life; reduces patient morbidity; and forestalls hospitalization. This will also reduce healthcare costs because an outpatient flow restoration procedure replaces the full hospitalization required to install a new graft.

Prior to starting hemodialysis the patient typically has a Teflon tube – called a “shunt” or "PTFE graft" - implanted into their forearm.

The shunt is the critical connection to the hemodialysis machine, since the patient’s blood is withdrawn and returned via needles inserted into the shunt.

Shunts suffer from 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.

Stenosis can be treated by angioplasty, a procedure where doctors insert a special balloon catheter into the graft and expand the balloon to restore flow.

However, until Transonic developed the flow-measurement catheters, doctors had no way to intraoperatively measure the flow improvements caused by angioplasty, and it was common to have to have multiple angioplasty sessions before flow was truly restored.

The new Transonic technology lets doctors measure flow changes before & after angioplasty by simply inserting a catheter into the graft and making an injection of room-temperature saline.

Doctors can release patients from the radiology suite confident that they’ve eliminated the graft stenosis and that they will not have to repeat the angioplasty session days later.

This results in reduced patient discomfort, better patient health, and cost savings to health care providers.

Transonic and AngioDynamics, Inc. have commercialized the devices developed under Phase-I research, with sales starting in April 2004 (see links below).

Press Release announcing start of sales:

http://www.transonic.com/Hemodialysis_Home/News/Press_Releases/AngioDynamics/angiodynamics.html

AngioDynamics web page for AngioFlowTM meter and catheters:

http://www.angiodynamics.com/pages/products/angioFlow.asp.

Product brochure for AngioFlowTM meter and catheters:

http://www.angiodynamics.com/pages/pdf/AngioFlow3.25.pdf

Under this agreement, AngioDynamics will distribute Transonic-manufactured meters and catheters under the AngioDynamics brand name, and AngioDynamics will handle marketing, sales, and support.

The Commercialization timeline is given below :

• June, 2001 – Phase-I SBIR Research Completed

• March, 2002 – Transonic Systems receives FDA Approval for First-Generation catheter and meter

• September, 2002 – NIDDK Awards Transonic Phase-II SBIR to develop Second-Generation devices & evaluate them at three clinical study sites.

• December, 2002 – AngioDynamics and Transonic Systems sign OEM agreement

• April, 2004 – AngioDynamics begins sales of First-Generation catheter and flowmeter under the AngioDynamics brand name

The AngioDynamics-branded Transonic hardware is manufactured in Ithaca, NY.