Igaki-Tamai biodegradable stent (Kyoto Medical Planning) safe for long-term treatment of Coronary Artery Disease

The Igaki-Tamai biodegradable stent, from Kyoto Medical Planning, proved safe when implanted in humans with Coronary Artery Disease (CAD) over a 10-year study, a new study shows. The stent is already used in nine European Union countries and Turkey � but not in the US � to treat Peripheral Artery Disease (PAD), the disorder which results from fatty deposits that narrow leg arteries.However, no countries have approved the Igaki-Tamai stent for treating clogged heart arteries. In the study, researchers tracked 50 Japanese patients (44 men, average age 61 years old) who received 84 Igaki-Tamai stents between September 1998 and April 2000. The stents were not coated with drugs. After an average 10 years, researchers found that the survival rate was 98 percent free from cardiac death and 87 percent free from death from all causes. Results show that fifty percent of patients experienced no major cardiac complication and that acceptable major event complication rates were similar to those for bare metal stents. Although researchers expected stent degradation to take six months, the study indicated the stent was totally absorbed in three years. See: "Long-Term (>10 Years) Clinical Outcomes of First-In-Man Biodegradable Poly-l-lactic Acid Coronary Stents: Igaki-Tamai Stents" by Soji Nishio et al. Circulation. 2012;published online before print April 16 2012, doi:10.1161/CIRCULATIONAHA.110.000901