Drug-Eluting Stent Testing

Drug-eluting stents are typically used in cardiovascular procedures to promote the repair of diseased arteries by eluting or releasing drug products over time. Drug-eluting stents are composed of a medical device and a pharmaceutical product, so it presents unique challenges to development and regulatory approval. In addition, because they are implantable medical devices, they require additional review due to their extended contact with the human body.

STEMart provides a comprehensive suite of testing services to help manufacturer assess compliance with standards and regulatory requirements.

Applicable Standards

• United States Pharmacopeia USP <711>, Apparatus 4 Dissolution
• European Pharmacopoeia 2.9.3 Dissolution Test for Solid Dosage Forms
• ISO 10993 Biological Evaluation of Medical Devices
• ISO 25539-1 Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses
• ISO 25539-2 Cardiovascular Implants - Endovascular Devices - Part 2: Vascular Stents
• ISO 7198 Cardiovascular Implants and Extracorporeal Systems - Vascular Prostheses - Tubular Vascular Grafts and Vascular Patches
• ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
• ASTM F2942-13 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

Test Capabilities

• Drug Release Characteristics
• Flow-Through Cell Dissolution
• Biocompatibility Testing
• Extractables & Leachables
• Chemical Characterization
• Impurities Identification
• Pulsatile Durability Testing: Determine stent failure caused by typical cyclic blood vessel diametric distension by means of hydrodynamic pulsatile loading.
• Axial Durability Testing
• Crush resistance testing: Evaluate the stent's ability to resist permanent deformation or cyclic fatigue.
• S/N curve generation
• Bending Durability Testing: Evaluate the stent's ability to resist cyclic bending deformation.
• Torsion Durability Testing: Evaluate the stent's ability to resist cyclic torsional deformation.
• Stability Testing

Analytical Techniques to Support Drug-Eluting Stent Testing

• Chromatographic Characterization – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
• Spectroscopy Characterization – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
• Extraction Techniques – Soxhlet, Reflux, Immersion, Agitation, etc.

STEMart provides comprehensive testing services to help manufacturer investigate the interactions, safety and efficacy of all component materials and the drug products in the drug-eluting stent. If you want to learn more detail about our testing services, or would like to consult with the experts at STEMart, please feel free to contact us.