Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polyme...Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polymer-free stent system with nanotechnology and elutes rapamycin (1.6 μg/mm2) and probucol (0.8 μg/mm2). The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography (OCT) findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.展开更多
文摘Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polymer-free stent system with nanotechnology and elutes rapamycin (1.6 μg/mm2) and probucol (0.8 μg/mm2). The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography (OCT) findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.