Study Shows Drug-Coated Device Opens Peripheral Arteries, Dissolves

Taking minimally invasive treatment to a new level, a bioresorbable drug-eluting scaffold appears to be effective in opening blocked blood vessels in the legs and pelvis, suggest six-month results of the Esprit trial.

The bioresorbable vascular scaffold (BVS) looks and works like a stent to open up blocked arteries in the legs or pelvis, while the drug coating prevents reclogging, or restenosis. The BVS is called a scaffold rather than a stent because it is a temporary structure that naturally dissolves into the blood stream within 18 months to two years, rather than a permanent implant.

“The six month results are very promising – we’re seeing zero restenosis in the first patients to receive the BVS in the peripheral arteries, the vast majority of whom suffered moderate to severe pain while walking prior to treatment and had very little to no pain after treatment,” said Johannes Lammer, M.D., professor of radiology and director of the Division of Cardiovascular and Interventional Radiology at the Medical University of Vienna, Austria. “The BVS combines the best of proven treatments while avoiding some of the problems. It opens arteries and prevents restenosis, then resorbs into the blood stream so there are no stent breaks, no prolonged irritation or delayed in-stent restenosis and no interference with magnetic resonance imaging or surgery.”

In the study of the Esprit BVS, 35 patients were treated for blockages in the pelvic or main leg artery. Six months after treatment, all of the arteries in the 34 patients who were followed remained open, with the narrowing reduced from an average of 80 percent prior to treatment to 13 percent after treatment. Prior to treatment, 32 patients (91 percent) had moderate to severe pain while walking, and no patients were pain-free. Six months after treatment, 29 patients (85 percent) had no pain while walking, and only one (3 percent) had moderate pain.

The BVS is made of polylactide, which naturally resorbs in the blood stream and has been shown to be safe in other medical uses, such as for dissolving stitches.