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Improved foam for varicose veins found to be safe in preliminary results from phase II trial
Date:3/16/2008

he small size of the bubbles, the consistency of the foam and the solubility of carbon dioxide.

However, patients with a right-to-left shunt in their hearts a common, usually asymptomatic heart defect in about one-fourth of the population are at increased risk of foam bubbles crossing the shunt and going to the brain or heart without being filtered in the lungs, according to Regan. These patients, the subjects of the study, are continuously monitored by transcranial Doppler ultrasound of the brain before, during and after the procedure. They also undergo magnetic resonance imaging (MRI) of the brain, visual testing, neurological examinations and examinations for changes in cardiac markers in the blood.

During the procedure, a small catheter is placed in the malfunctioning GSV, and the Varisolve foam is injected into the vein. The GSV is compressed in the groin to trap the foam in the leg and additional foam is injected. The patients leg is then put in a compression dressing and stocking, and the patient is able to get up and walk immediately.

In more than 90 percent of the 28 patients studied so far (13 at Wake Forest Baptist) at six research sites across the country, tiny bubbles have been detected in the blood during the procedure. However, no neurological, visual or cardiac changes were observed in the monitoring. The study will continue until a total of 50 patients have been treated and monitored.


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Contact: Robin Brantley
rbrantle@wfubmc.edu
336-716-7334
Wake Forest University Baptist Medical Center
Source:Eurekalert

Page: 1 2

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