Materials and Manufacturing Technologies Available for Production of a Pediatric Bioabsorbable Stent

Transcatheter treatment of children with congenital heart disease such as coarctation of the aorta and pulmonary artery stenosis currently involves the use of metal stents. While these provide good short term results, there are long term complications with their use. Children outgrow metal stents, obligating them to future transcatheter dilations and eventual surgical removal. A bioabsorbable stent, or a stent that goes away with time, would solve this problem. Bioabsorbable stents are being developed for use in coronary arteries, however these are too small for use in pediatric congenital heart disease. A bioabsorbable stent for use in pediatric congenital heart disease needs to be low profile, expandable to a diameter 8 mm, provide sufficient radial strength, and absorb quickly enough to allow vessel growth. Development of absorbable coronary stents has led to a great understanding of the available production techniques and materials such as bioabsorbable polymers and biocorrodable metals. Children with congenital heart disease will hopefully soon benefit from the current generation of bioabsorbable and biocorrodable materials and devices.

[1]  S. Lobodzinski,et al.  Bioabsorbable coronary stents. , 2008, Cardiology journal.

[2]  H Shimokawa,et al.  Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic changes of the coronary artery in pigs in vivo. , 1998, Journal of the American College of Cardiology.

[3]  P. Erne,et al.  The Road to Bioabsorbable Stents: Reaching Clinical Reality? , 2006, CardioVascular and Interventional Radiology.

[4]  Dietmar Schranz,et al.  Bioabsorbable metal stents for percutaneous treatment of critical recoarctation of the aorta in a newborn , 2006, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[5]  A. Boffi,et al.  Metals and metal derivatives in medicine. , 2013, Mini reviews in medicinal chemistry.

[6]  C. Macaya,et al.  Absorbable stent: focus on clinical applications and benefits , 2012, Vascular health and risk management.

[7]  D. Hagler,et al.  Comparison of surgical, stent, and balloon angioplasty treatment of native coarctation of the aorta: an observational study by the CCISC (Congenital Cardiovascular Interventional Study Consortium). , 2011, Journal of the American College of Cardiology.

[8]  Donald Garlotta,et al.  A Literature Review of Poly(Lactic Acid) , 2001 .

[9]  P. Serruys,et al.  Bioresorbable scaffold technologies. , 2011, Circulation journal : official journal of the Japanese Circulation Society.

[10]  Raimund Erbel,et al.  Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial , 2013, The Lancet.

[11]  Raimund Erbel,et al.  Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries. , 2009, JACC. Cardiovascular interventions.

[12]  Ron Waksman,et al.  Update on bioabsorbable stents: from bench to clinical. , 2006, Journal of interventional cardiology.

[13]  J. Gray-Munro,et al.  Influence of surface modification on the in vitro corrosion rate of magnesium alloy AZ31. , 2009, Journal of biomedical materials research. Part A.

[14]  Liping Xu,et al.  In vitro degradation of biodegradable polymer-coated magnesium under cell culture condition , 2012 .

[15]  Bernard Chevalier,et al.  Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. , 2011, Journal of the American College of Cardiology.

[16]  H. Uehata,et al.  Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. , 2000, Circulation.

[17]  F. Prima,et al.  Electroformed iron as new biomaterial for degradable stents: development process and structure-properties relationship. , 2010, Acta biomaterialia.

[18]  J. Noonan Noonan Syndrome , 1994, Clinical pediatrics.

[19]  H. Singer,et al.  First biodegradable metal stent in a child with congenital heart disease: Evaluation of macro and histopathology , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[20]  P E McHugh,et al.  A corrosion model for bioabsorbable metallic stents. , 2011, Acta biomaterialia.

[21]  Patrick W Serruys,et al.  From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? , 2012, European heart journal.

[22]  J. Roelandt,et al.  Images in Cardiovascular Medicine , 2000 .

[23]  J. Graham,et al.  Down syndrome--an update and review for the primary pediatrician. , 1991, Clinical pediatrics.

[24]  Patrick W Serruys,et al.  Bioresorbable Scaffold: The Advent of a New Era in Percutaneous Coronary and Peripheral Revascularization? , 2011, Circulation.

[25]  P. Painter,et al.  Fundamentals of Polymer Science , 2019 .

[26]  M. Chiba,et al.  Chronic magnesium deficiency decreases tolerance to hypoxia/reoxygenation injury in mouse heart. , 2011, Life sciences.

[27]  M. Auerbach,et al.  Clinical use of intravenous iron: administration, efficacy, and safety. , 2010, Hematology. American Society of Hematology. Education Program.

[28]  A. Schindler,et al.  Sustained drug delivery systems II: Factors affecting release rates from poly(epsilon-caprolactone) and related biodegradable polyesters. , 1979, Journal of pharmaceutical sciences.

[29]  Michael Weyand,et al.  First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby , 2005, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[30]  G. Homuth,et al.  Magnesium used in bioabsorbable stents controls smooth muscle cell proliferation and stimulates endothelial cells in vitro. , 2012, Journal of biomedical materials research. Part B, Applied biomaterials.

[31]  A. C. Vieira,et al.  Mechanical study of PLA-PCL fibers during in vitro degradation. , 2011, Journal of the mechanical behavior of biomedical materials.

[32]  J O Hollinger,et al.  Biodegradable bone repair materials. Synthetic polymers and ceramics. , 1986, Clinical orthopaedics and related research.

[33]  A. Göpferich,et al.  Mechanisms of polymer degradation and erosion. , 1996, Biomaterials.

[34]  J. Tanigawa,et al.  Coronary bioabsorbable magnesium stent: 15-month intravascular ultrasound and optical coherence tomography findings. , 2007, European heart journal.

[35]  Diego Mantovani,et al.  Iron–manganese: New class of metallic degradable biomaterials prepared by powder metallurgy , 2008 .

[36]  Patrick W Serruys,et al.  A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods , 2009, The Lancet.

[37]  M. Hadchouel,et al.  Syndromic paucity of interlobular bile ducts (Alagille syndrome or arteriohepatic dysplasia): review of 80 cases. , 1987, The Journal of pediatrics.

[38]  A Haverich,et al.  Left main coronary artery fistula exiting into the right atrium , 2003, Heart.

[39]  C. Mavroudis,et al.  Coarctation of the aorta: midterm outcomes of resection with extended end-to-end anastomosis. , 2009, The Annals of thoracic surgery.

[40]  P. Hunold,et al.  Images in cardiovascular medicine. Novel magnetic resonance-compatible coronary stent: the absorbable magnesium-alloy stent. , 2005, Circulation.

[41]  P. Serruys,et al.  Biodegradable stents and non-biodegradable stents. , 2009, Minerva cardioangiologica.

[42]  Liping Xu,et al.  Characteristics and cytocompatibility of biodegradable polymer film on magnesium by spin coating. , 2012, Colloids and surfaces. B, Biointerfaces.

[43]  Philipp Beerbaum,et al.  Long-term biocompatibility of a corrodible peripheral iron stent in the porcine descending aorta. , 2006, Biomaterials.

[44]  Patrick W Serruys,et al.  A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial , 2008, The Lancet.

[45]  H. D. Merchant,et al.  Grain structure of thin electrodeposited and rolled copper foils , 2004 .

[46]  K. Robinson,et al.  Novel bioabsorbable salicylate‐based polymer as a drug‐eluting stent coating , 2008, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[47]  C. Loffredo Epidemiology of cardiovascular malformations: prevalence and risk factors. , 2000, American journal of medical genetics.

[48]  M. Peuster,et al.  A novel approach to temporary stenting: degradable cardiovascular stents produced from corrodible metal—results 6–18 months after implantation into New Zealand white rabbits , 2001, Heart.

[49]  Shih-Jung Liu,et al.  Fabrication of Balloon-Expandable Self-Lock Drug-Eluting Polycaprolactone Stents Using Micro-Injection Molding and Spray Coating Techniques , 2010, Annals of Biomedical Engineering.