@article{0ed6febb4337421e80a733c679e9c0fa,
title = "Biodegradable stent use for congenital heart disease",
abstract = "At the present time, there are no biodegradable stents available for use in pediatric patients with congenital heart disease, despite this population being most likely to benefit from a technology that will eventually disappear enabling all future treatment options and potentially future vessel growth. Current research is focused on identifying optimal biodegradable material and stent design to develop larger diameter stents with reasonable profile and strength to sustain the larger pulmonary arteries and aortic obstruction. In this article, we review the challenges faced with fabricating a larger diameter biodegradable stent and the currently available biodegradable scaffolds made for coronary and peripheral artery interventions and provide a summary of the current biodegradable stents being assessed for congenital heart disease applications.",
keywords = "Biodegradable stents, Bioresorbable polymers, Congenital heart disease, Pediatric stents, Poly-L-lactic-acid",
author = "{Veeram Reddy}, {Surendranath R.} and Welch, {Tre R.} and Nugent, {Alan W.}",
note = "Funding Information: It is unfortunate that the larger medical device companies are reluctant to invest time and resources to bring a BDS to market for use in CHD due to the significantly smaller market size compared to coronary and peripheral artery intervention market. There is however governmental, institutional, and private funding being made available for the handful of groups working on fabricating a larger diameter BDS for use in CHD. The authors' BDS team has shown promising pre-clinical results with the Illusicor{\texttrademark} stent. With research funding from Children's Health, UTSW, and an R21 grant, the unique stent design with double opposing helical coils makes it possible to fabricate larger diameter stents that are needed for use in CHD [ 21 , 30 , 31 ]. Engineering and preclinical analysis of this stent in sizes from 3 to 12 mm diameter have been published [ 32–36 ]. Unpublished results of long-term degradation of small 3–4 mm diameter stents are also very encouraging. The company reports breakthrough device application to move the Illusicor{\texttrademark} stent forward to an investigation device exemption with the FDA. The 480 Biomedical team has completed preclinical trials of a self-expanding BDS with SBIR-STTR grant funding to evaluate a purpose built absorbable scaffold stent for pulmonary artery stenosis (2016) and neonatal aortic coarctation (2018). Per company report, they were in communication with the FDA to initiate early feasibility first-in-human studies, to treat pulmonary artery stenosis, which has not occurred. The Pediastent LLC group has received SBIR funding in 2018 to evaluate the ZeBRa stent and a polymer coated nanocomposite magnesium stent for treatment of neonatal aortic coarctation. With funding from A Giving Heart Foundation and The University of Iowa Clinical and Translational Science Award Grant, Shibbani and colleagues recently published the promising acute and subacute results of the 6 × 18 mm bioresorbable pediatric stent [ 29 ]. First-in-human trials for one or more of these BDS purpose built for use in patients with CHD are eagerly awaited. Publisher Copyright: {\textcopyright} 2021",
year = "2021",
month = jun,
doi = "10.1016/j.ppedcard.2021.101349",
language = "English (US)",
volume = "61",
journal = "Progress in Pediatric Cardiology",
issn = "1058-9813",
publisher = "Elsevier Ireland Ltd",
}