PCI & AimRadial 2018 | A novel stent concept for South America - Ramses Galaz

1. A novel stent concept for South America
Ramses Galaz - GSE Biomedical
Arturo Abundes, Instituto Nacional de Cardiología, Mexico City, Mexico
AIM RADIAL 2018
December 1st, Sarasota, Florida

2. Medical devices that can be developed and manufactured
and their respective estimated annual markets in Latin-America (USD)
Coronary stents
$500M
Artificial Heart Valves
$28M
Stent grafts for Aneurysm Repair
$60M
Occluder devices
$40M
Filters
$20M
Catheters and Delivery Systems
$80M
Peripheral stents
$400M
Neurovascular stents and
flow diverters
$40M
CAGR of 5%-13% for these devices is forecasted from 2018 - 2024

3. Roadmap for a stent device from scratch to
production
Design
& Simulation
Quality
inspection
In-vitro testing
ISO 25539
ASTM F2079,
F2081, F2394,
F2477, F2514,
F2942, F3067
Animal studies
Regulatory filingClinical trials
GMP
Manufacturing
ISO 13485
21 CFR Part 820
Manufacturing

4. Stent design requirements (ISO 25539-2)
STRUCTURE & FLOW
• Radial Strength
• Surface finish
• Geometrical pattern
• Strut profile
• Life cycle against Fatigue
• Flex/Kink
• Recoil percentage
• Dogboning
• Radiopacity (Visibility)
• Coating integrity (DES)
• Stress-strain analyses
• Homogeneous fluid shear
stress
DEPLOYABILITY & PATENCY
• Navigation
• Pushability
• Crossability
• Dislodgement force
• Patency
• Stent migration
• Coating integrity during
deployment
CLINICAL PERFORMANCE
• Biocompatibility
• Low restenosis rates
• Proper Hemodynamic
function
• Proper arterial remodeling
• Low clinical adverse effects
(vessel trauma, vessel
occlusion, ischemia due to
emboli or in-stent
thrombosis, trauma to
adjacent structures)

5. Design for Structural rigidity
Flexural rigidity

6. Manufacturing
• For certain countries, cheap stent
• Cheap does not mean low quality, it means that

7. Electropolishing

8. Surface finish measurements

9. Hemodynamic and fluid shear stress simulations

10. Mechanical and navigation tests

11. Animal studies

12. Other projects we are developing for low-cost production
in the cardiovascular field
Electrospun AAA Stent grafts PDA Occluders Drug-Eluting Stents