The FORTITUDE® sirolimus-eluting bioresorbable scaffold (BRS) was evaluated in two multi-center trials in Colombia, South America1 (MEND II) and Italy2 (RENASCENT). The patients enrolled in these studies had symptomatic coronary artery disease and underwent percutaneous coronary intervention (PCI).
The FORTITUDE® Study: Conclusions
The FORTITUDE® Study, an international, multi-center investigation of the clinical performance of the 1st generation (150 µm) Amaranth BRS showed:
- High clinical device success rate (98.4%)
- Low MACE rates (4.9%; 2 out of 3 events related to peri-procedural MIs)
- Low angiographic binary restenosis (1.6%) and late loss (0.27 ± 0.41 mm)
- High levels of strut coverage (96%) and scaffold stability at 9 months
Amaranth’s unique ultra-high molecular weight PLLA combined with proprietary polymer processing technology has led to the further miniaturization of the BRS. Two FIH (first in human) studies have already tested second and third generation Amaranth scaffolds:
- RENASCENT II (115 µm BRS): Enrollment completed, 9-month follow-up completed
- RENASCENT III (sub-100 µm BRS): Enrollment completed
Due to the unique polymer features, these future generation scaffolds have the potential to match the biological and mechanical performance of current metallic DES.
1. Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent (MEND II)
2. Safety and Efficacy Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT)