Video summary
Dr. Ashok Seth | MeRes100™ Bioresorbable Stent Finding | EuroPCR
Main summary
Key takeaways
Summary
The video discusses the MeRes100™ bioresorbable scaffold, a significant advancement in cardiovascular stenting technology. Key points include:
Device Specifications
- The MeRes100™ has a strut thickness of 100 microns, compared to the previous generation's 150 microns.
- It features a unique architecture with closed cells at the edges and open cells in the middle, enhancing access to side branches.
- It is made from a poly(lactic acid) (PLLA) backbone and has a ceramist coating that elutes similarly to previous devices.
Clinical Study
- The first-in-human study involved 108 patients with predefined endpoints for efficacy and safety.
- Results showed:
- Extremely low weight loss at 0.15 mm, comparable to the best metallic stents.
- 99.3% strut coverage at one year, confirmed by OCT (optical coherence tomography).
- No scaffold thrombosis and only one ischemia-driven target lesion revascularization (TLR) in the initial follow-up.
- Two-year follow-up data maintained these favorable outcomes, with only one additional ischemia-driven TLR and no scaffold thrombosis.
Future Studies
A major pivotal study is planned to randomize 2000 patients between the MeRes100™ and a sirolimus-eluting stent, starting in the third quarter of the year.