Phase 2 trial finds injectable varicose-veins treatment to be safe

April 1, 2008

Winston-Salem, N.C. - Results of a recently completed phase 2 clinical trial show that a new foam for treatment of varicose veins has proved safe for use, HealthDay News reports.

Winston-Salem, N.C. - Results of a recently completed phase 2 clinical trial show that a new foam for treatment of varicose veins has proved safe for use, HealthDay News reports.

The trial, conducted at Wake Forest University Baptist Medical Center, found that use of injectable Varisolve microfoam caused no neurological, visual or cardiac changes in a small group of patients with a common heart defect. The trial was funded by Varisolve- maker BTG International, West Conshohocken, Pa.

The phase 2 trial looked at 28 patients who had right-to-left shunt in their heart, a relatively common defect that affects about 25 percent of the population. In people who have this defect, there is an increased risk that bubbles from injectable foams to treat varicose veins will cross the shunt and go to the brain or heart without being filtered in the lungs.

While tiny bubbles were detected in the blood of 90 percent of the 28 patients treated with Varisolve, there were no signs of neurological, visual or cardiac changes during monitoring using ultrasound, MRI and other methods.

HealthDay News reports the study will continue until 50 patients have been treated and monitored.