Abstract
The quest for an ideal biodegradable stent for both adult coronary and pediatric congenital heart disease applications continues. Over the past few years, a lot of progress has been made toward development of a dedicated pediatric biodegradable stent that can be used for congenital heart disease applications. At present, there are no biodegradable stents available for use in congenital heart disease. In this article, the authors review the different biodegradable materials and their limitations and provide an overview of the current biodegradable stents being evaluated for congenital heart disease applications.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 81-94 |
| Number of pages | 14 |
| Journal | Interventional Cardiology Clinics |
| Volume | 8 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2019 |
Funding
With grant funding via the NHLBI SBIR pathway, the 480 Biomedical, Inc. (MA, USA) has developed and analyzed a pediatric resorbable scaffold (PRS, ). This is a PLLA-based self-expanding stent with a unique composite design made of a PLLA fiber braid with elastomer coating that makes the stent as strong as the conventional metal stents used in pediatric practice but dissolves in 12 to 18 months. The stent is a composite consisting of braided fiber monofilaments of poly ( Fig. 12 l -lactide-co-glycolide) L-PLGA coated with poly (glycolide-co-caprolactone) PGCL. 56 The L-PLGA stents without a coating showed a chronic outward radial force of 90 mm Hg and a radial stiffness of 28 mm Hg. This improved to a radial stiffness of 700 mm Hg with a coating. The stent has radiopaque markers attached to the stent for visualization. The PRS stents were evaluated in native pulmonary arteries in growing pigs showing excellent patency to 18-month full resorption with low inflammation score. The stents are currently being evaluated in animals to treat peripheral artery stenosis and coarctation and midterm results are expected this year. The stent is deliverable through a 5- or 6-Fr delivery system with an expanded diameter range of 7 to 10 mm and a length of 15 to 20 mm. The 480 Biomedical team reports that they are communicating with the FDA to initiate early feasibility first-in-human study. They plan to treat 10 subjects with PA stenosis with a Ø7X15 mm PRS and evaluate procedural success, safety at 1 month and patency at 6 months. They have also received NIH SBIR grant funding for the development of a similar stent scaffold designed specifically for the treatment of coarctation of the aorta in neonates. The work done at 480 Medical has not been published but has been presented at multiple national meetings. 57
Keywords
- Biocorrodible metals
- Biodegradable stents
- Bioresorbable polymers
- Congenital heart disease
- Pediatric stents
- Poly-L-lactic-acid
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
