Stent Design Can't Wait for Physical Testing to Catch Every Flaw

A stent's real-world performance under physiological loading is what matters, and physical bench testing, preclinical studies, and clinical investigations alone are a slow way to find that out. Design issues often surface late in this process, exactly when they're most expensive to fix. Regulatory agencies, including Notified Bodies and the FDA, are increasingly recognizing computational modeling as valid supporting evidence, which opens the door to earlier design insights, fewer physical testing iterations, and faster development without cutting corners on safety or performance.

Webinar Scope

This webinar looks at how in-silico methods can support the development and regulatory submission of stent devices, aligned with standards such as ISO 25539 and relevant ASTM standards, including ASTM F2477 and F3067. You'll see how computational modeling speeds up product development, strengthens regulatory submissions, and reduces dependence on physical prototypes by complementing traditional testing with simulation-based evidence.

Topics Covered

• Why physical and clinical testing alone slows stent device development

• How the EU and FDA view in-silico evidence in regulatory submissions

• Building a credible in-silico evidence package for stent devices

• Using computational modeling to support compliance with ISO 25539 and relevant ASTM standards

• Simulating stent deployment, expansion, radial strength, fatigue performance, and vessel interaction under physiological loading

• Cutting physical test iterations while maintaining regulatory confidence

• Positioning simulation results alongside traditional bench and preclinical test data

• Practical considerations for model verification and validation

What In-silico Evidence Delivers

• Earlier insight into device performance, deployment behavior, fatigue resistance, and safety, before physical prototypes exist

• Greater confidence in simulation-driven development, with less reliance on physical testing

• Faster design iterations and optimization throughout development

• A stronger, more comprehensive regulatory evidence package supporting submissions

Who Should Attend?

• R&D and design engineers developing coronary, peripheral, or neurovascular stent devices

• Simulation, verification, and validation engineers supporting medical device development

• Regulatory affairs professionals responsible for medical device submissions

• Teams looking to cut the cost and time tied to extensive physical prototype testing

• Anyone integrating in-silico evidence into the development and regulatory approval process for stent devices

Relevant Standards Discussed

• ISO 25539 – Cardiovascular implants and endovascular devices

• ASTM F2477 – Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

• ASTM F3067 – Standard Test Method for Radial Loading Characteristics of Balloon Expandable and Self-Expanding Vascular Stents