A new biodegradable stent implanted in heart patients has proven to be a safe, effective alternative to conventional devices, according to a 10-year study published in the American Heart Association journal Circulation.
The new Igaki-Tamai stents -- mesh tubes inserted into clogged or narrowed arteries to help prop them open and allow for blood flow to the heart – have been used in Europe and Turkey, but not in the United States, to treat peripheral artery disease in leg arteries. But they have not been approved for treating clogged heart arteries.
"We have needed this long-term clinical data to clarify the coronary safety of the stent," said lead researcher Dr. Kunihiko Kosuga, director of cardiology at Shiga Medical Center for Adults in Moriyama City, Japan. "Our findings will pave the way for the entry of coronary stents made of biodegradable polymers into the real world of interventional cardiology."
The new device offers an improvement over conventional metal stents, which are sometimes coated with drugs that remain in the body and can reclog. The biodegradable stent is made from a cornstarch-based material that dissolves into the artery wall, reducing the risk of blood clots.
For the study, researchers tracked 50 Japanese patients who received Igaki-Tamai stents between September 1998 and April 2000. Researchers found 98 percent had no heart problems or increased risk of death.