What are Drug-Eluting Stents?
Drug-eluting stents are implantable medical devices typically used in cardiovascular procedures to repair diseased arteries. These stents generally elute, or release over time, a drug product to promote healing such as reducing scaring to affected tissue. Drug-eluting stents present unique challenges to development and regulatory approval because they incorporate properties of both a medical device and a pharmaceutical product. Therefore, all component materials and the drug product require thorough investigation for interactions, safety, and efficacy. Additionally, since these are implantable devices, they require additional scrutiny because of their extended contact with the human body. Guidance for development of devices like drug-eluting stents has been set forth in documents like ISO 10993-1.
Drug-Eluting Stent Services at EKG Labs
EKG Labs is an industry leader in providing analytical services to support the development of drug-eluting stents and other combination medical devices. EKG Labs has brought together the know-how of pharmaceutical and material science to help clients navigate the testing and regulatory challenges associated with these devices. Our capabilities include:
- Full scale GMP analytical Extractables and Leachables programs to understand how the device and the pharmaceutical product interact
- Drug-Device Biocompatibility Studies
- Method Development
- Method Validation
- Chemical Characterization
- Impurity Identification
- Storage and Stability
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.