BTG presents Varisolve safety trial data at ACP

UK drug developer BTG presented the results of a Phase II safety study of its Varisolve (polidocanol endovenous microfoam) at the American College of Phlebology congress in Florida.

Principal investigator Kathleen Gibson said: "there is increasing interest in using foam sclerosant to treat varicose veins because of the many benefits to patients, including the speed of treatment and no requirement for general or tumescent anesthesia. However, concerns have been raised relating to the potential risk of cerebral gas embolization, particularly in patients who have a right-to-left cardiac shunt that may allow residual bubbles from the foam to enter the arterial circulation."

The company says that the results of the multicenter Phase II safety study confirm that treatment with Varisolve in subjects with R-L shunts does not cause cerebral injury. The study objective was to treat and follow up 50 patients with detected middle cerebral artery bubbles. Of 82 patients treated, 73% had detection of MCA bubbles. No new MRI lesions or abnormal findings in the neurological and visual field examinations were detected in any patients, and none had any evidence of cardiac ischemia. Sapheno-femoral junction reflux was eliminated in 94% of the subjects at one month, and 88% had occlusion of the great saphenous vein.