BACKGROUND To assess the effect of thermal balloon angioplasty on surgically created peripheral arterial stenoses. METHODS Unilateral femoral arterial stenoses were created in 17 neonatal lambs (Dorset X Suffolk/Mule), using absorbable sutures. Six to 8 weeks later, the stenoses were dilated using either a standard (N=5), or thermal balloon angioplasty (N=9). Immediate angiography, flow and pressure gradient measurements were made to assess the acute result following either procedure. The survivors were followed up for a further period of 4 to 6 weeks, and a terminal angiographic study performed. The thermally treated segments of vessels were removed for qualitative histologic analysis. RESULTS Thermal angioplasty appeared to be acutely successful in eight of nine animals, compared with one of five successful procedures following standard angioplasty. Higher therapeutic temperatures (> or = 80 degrees C) were associated with vascular complications. At the terminal study, stenoses had recurred in four of six survivors successfully treated with thermal angioplasty. Histologic studies demonstrated non-uniform effects of thermal dilation on the vessel wall, with variable changes ranging from partial or full-thickness tears, fibroblastic or myocyte proliferation, and disorganization of the vessel wall layers. CONCLUSIONS Thermal angioplasty appears to be acutely more beneficial compared with standard angioplasty. However there is a significant recurrence of stenoses, and non-uniform changes in the vessel wall.