1. DVP, WW Clinical Research
Clinical Challenges to Device Innovation: Bioabsorbable DES – Industry View
Stanley E. Fink, PhD
DVP, WW Clinical Research
Abbott Vascular

2. Stanley E. Fink, PhD
Employee Abbott Vascular

3. Bioresorbable Vascular Scaffolds
Delivery System – compatible with current tools and procedures
Bio(re/ab)sorbable Scaffold – gradual degradation with well understood metabolization
Drug - Known drug, with dose density and controlled release similar to approved DES

4. Clinical Program Challenges
Traditionally gather early safety data (FIM)
FIM: patients 30 – 130
- differs in requirement to understand mechanisms of action: via diverse imaging modalities
Angio, IVUS, Virtual Histology, Palpography, OCT, MSCT
Multiple time points
Critically
Important

5. Clinical Program Challenge
Larger Experience: single arm trial; 200 – 1000 patients
More sizes
Overlapping
More complex lesions
Some continued imaging
Clinical Endpoints
Various time points
Bridging absorption timepoint
Supporting long-term safety data for IDE & PMA

6. Clinical Challenges Short Term
IDE – Prospective, randomized, single masked, multicenter trial
Clinical Endpoint TLF ~ patients
Control Arm: state-of-the-art metallic DES
Clinical follow-up: 30 days, 6 months, 1-5 years
One year: must perform as DES
Some imaging IVUS, OCT? – dependent on OUS data
Deliverability
Acute and sustained revascularization
Vessel Scaffolding
Drug pK

7. Clinical Challenges Long Term
Demonstrating Benefits
Reduction in DAPT
Reduction in lesion/scaffold thrombosis
Complete revascularization – multiple vessel – full polymer jacket
Vulnerable / non flow limiting lesions
Reduction in lesion specific angina
Flat TLF slope over time
Vascular remodeling
Restoration of vasomotor function
CABG options maintained
Health Economics