Maglev-fabricated long and biodegradable stent for interventional treatment of peripheral vessels

Abstract

Abstract While chronic limb-threatening ischemia is a serious peripheral artery disease, the lack of an appropriate stent significantly limits the potential of interventional treatment. In spite of much progress in coronary stents, little is towards peripheral stents, which are expected to be long and biodegradable and thus require more breakthroughs in core techniques. Herein, we develop a long & biodegradable stent (LBS) with a length of up to 118 mm based on a metal-polymer composite material. Nitriding treated iron with elevated mechanical performance was applied as the skeleton of the stent, and a polylactide coating was used to accelerate iron degradation. To achieve a well-prepared homogeneous coating on a long stent during ultrasonic spraying, a magnetic levitation (Maglev) was employed. In vivo degradation of the LBS was investigated in rabbit abdominal aorta/iliac arteries, and preclinical safety and efficacy were evaluated in canine infrapopliteal arteries. First-in-man implantation of LBS was carried out in the below-the-knee artery, and the 6–13 months follow-ups demonstrated the feasibility of the first LBS.