A novel self-expanding primarily bioabsorbable braided flow-diverting stent for aneurysms: initial safety results

Abstract

IntroductionThe advent of metal flow-diverting stents has provided neurointerventionalists with an option for treating aneurysms without requiring manipulations within the aneurysm sac. The large amount of metal in these stents, however, can lead to early and late thrombotic complications, and thus requires long-term antiplatelet agents. Bioabsorbable stents have been postulated to mitigate the risk of these complications. Here we present early data on the first self-expandable primarily bioabsorbable stent for aneurysms.MethodsBraided stents were developed using poly-L-lactic acid fibers with material surface area similar to metal flow diverters. Crush resistance force, hemolysis, and thrombogenicity were determined and compared with existing commercial devices. Stents were deployed in infra-renal rabbit aortas to determine angiographic side branch patency and to study neointima formation for a 1-month follow-up period.ResultsCrush resistance force was determined to be on the order of existing commercial devices. Hemolytic behavior was similar to existing metal devices, and thrombogenicity was lower than metal flow-diverting stents. A smooth neointimal layer was found over the absorbable stent surface and all covered side branches were patent at follow-up.ConclusionThe design of self-expanding primarily bioabsorbable flow-diverting stents is possible, and preliminary safety data is consistent with a favorable profile in terms of mechanical behavior, hemocompatibility, side branch patency, and histological effects. Additional in vitro and long-term in vivo studies are in progress and will help determine aneurysm occlusion rates and absorption characteristics of the stent.

Fluoroscopy, CT, and MR imaging characteristics of a novel primarily bioresorbable flow-diverting stent for aneurysms

“…Bioresorbable flow-diverting stents have the potential to impact aneurysm treatment by reducing the need for anticoagulation, minimizing long term complications associated with metal stents, and by improving postprocedure follow-up and assessment. 6 Bioresorbable vascular stents have been in development over the past 30 years, with the majority of these stents having been developed for coronary use. The Igaki-Tamai bioabsorbable coronary stent was the first to be implanted in humans and was made from poly-L-lactic acid.…”

“…Potential benefits of a biodegradable stent would include reduced or eliminated delayed stent thrombosis, restoration of vasomotion, reduced restenosis, and improved follow-up imaging with CT or MR. 5 A novel self-expanding primarily bioresorbable intracranial flow-diverting stent (BFDS) is currently involved in preclinical studies. 6 Radiopacity is an important consideration of intracranial stent development for both deployment in clinical situations and imaging follow-up. 7,8 This study is an imaging evaluation of novel BFDS compared to the leading metal stent using fluoroscopy, CT, and MRI.…”

“…A novel self-expanding primarily bioresorbable intracranial flow-diverting stent (BFDS) is currently involved in preclinical studies. 6 Radiopacity is an important consideration of intracranial stent development for both deployment in clinical situations and imaging follow-up. 7,8 This study is an imaging evaluation of novel BFDS compared to the leading metal stent using fluoroscopy, CT, and MRI.…”

Effects of annealing temperature on both radial supporting performance and axial flexibility of poly(L‐lactic acid) braided stents

“…BBS provide early support and then disappear completely, freeing the lumen from permanent foreign bodies and avoiding subsequent removal 5,6 . In addition, BBS have excellent biocompatibility and react well with human body, avoiding a series of histopathological problems, such as, inflammation and thrombosis 7,8 . Thus, BBS become a research hotspot and are expected to be widely used in clinic.…”

“…5,6 In addition, BBS have excellent biocompatibility and react well with human body, avoiding a series of histopathological problems, such as, inflammation and thrombosis. 7,8 Thus, BBS become a research hotspot and are expected to be widely used in clinic. However, the poor mechanical properties of BBS, compared with MBS, limit their potential applications.…”