A new foam for treatment of varicose veins proved safe in patients, according to the results of a Phase II clinical trial.

The trial found that use of injectable Varisolve microfoam didn’t cause any neurological, visual or cardiac changes in a small group of patients with a common heart defect.

Since 1997, injectable sclerosant foams have been a standard treatment for spider veins and small varicose veins. These foams are typically made by mixing a sclerosant — an irritant that causes damage to the vein wall and subsequent scarring — with room air. Varisolve is made with carbon dioxide and is relatively painless compared to other sclerosants, which can cause burning, according to Dr. John D. Regan, clinical director of the interventional section in the department of radiology at Wake Forest University Baptist Medical Center.

Regan was expected to present the study’s findings March 18 in Washington, D.C., at the annual scientific meeting of the Society of Interventional Radiology. The study was funded by BTG International, which makes Varisolve.

The 28 patients studied so far had right-to-left shunt in their hearts. This common, usually asymptomatic heart defect affects about one-quarter of the population. In people with this defect, there’s 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, Regan said.

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. The study will continue until 50 patients have been treated and monitored.

(Source: Wake Forest University Baptist Medical Center, news release, March 17, 2008)