Drug Eluting Stent Release Profile Testing
The testing of drug eluting stents (DES) is a critical component in ensuring the safety and efficacy of these medical devices. DES are used to treat coronary artery disease, providing long-term benefits by releasing medication directly at the site of intervention. The release profile testing ensures that the medication is delivered as intended, without excessive or premature release, which could lead to adverse effects.
At Eurolab, our expertise in this area allows us to provide comprehensive and accurate testing services for drug eluting stents. Our team of engineers and scientists has extensive experience in understanding the complexities involved with these devices, ensuring that we can deliver reliable test results every time. We employ state-of-the-art equipment and follow internationally recognized standards such as ISO 10993-18:2016 to ensure our testing is both accurate and reproducible.
The process of testing involves several steps, including the preparation of the stent for testing, the application of standard test conditions, and the analysis of the results. The stent is typically prepared by soaking it in a solution that mimics physiological conditions, followed by incubation at specific temperatures and humidity levels to simulate body environment exposure.
Once the stent has been prepared, we measure the release profile using various techniques such as high-performance liquid chromatography (HPLC) or ion-chromatography. These methods allow us to quantify the amount of drug released over time accurately. We also perform mechanical tests on the stents to ensure they meet strength and durability requirements before and after drug elution.
The data collected during these tests is then analyzed using statistical tools to determine compliance with regulatory guidelines. This includes ensuring that the release rate falls within acceptable limits as defined by international standards like US FDA 21 CFR Part 820, ISO 15376-4:2019, and EN ISO 15376-4:2019.
Our comprehensive approach ensures that every aspect of the drug eluting stent is tested thoroughly. From initial design verification to final product release, our team works closely with clients throughout the process to ensure all necessary steps are followed correctly. By leveraging our deep understanding of DES technology and rigorous testing protocols, we offer peace of mind knowing your products meet highest quality standards.
Scope and Methodology
Testing Scope:
| Parameter | Description |
|---|---|
| Drug Elution Profile | Measurement of the amount of drug released over time using HPLC or ion-chromatography. |
| Mechanical Properties | Evaluation of tensile strength, flexibility, and durability before and after elution. |
| Bio-Compatible Testing | Assessment for biocompatibility according to ISO 10993-18:2016. |
Testing Methodology:
- The stent is prepared by soaking it in a solution that simulates body fluid conditions.
- Incubation occurs at controlled temperature and humidity levels to mimic physiological exposure.
- Drug concentration measurements are taken periodically using HPLC or ion-chromatography.
- Mechanical testing follows ISO 15376-4:2019 guidelines, assessing tensile strength and flexibility.
Eurolab Advantages
Our team of experienced professionals brings years of combined expertise in medical device testing to every project. With state-of-the-art facilities and cutting-edge technology at our disposal, we can provide you with precise and reliable results that meet all relevant regulatory requirements.
- Comprehensive Testing: We cover a wide range of tests including biocompatibility studies, mechanical property assessments, and drug elution profiles.
- Regulatory Compliance: Our services are tailored to ensure compliance with international standards such as US FDA 21 CFR Part 820, ISO 15376-4:2019, EN ISO 15376-4:2019.
- Client Collaboration: We work closely with clients from concept design through final product release to ensure all necessary steps are completed accurately and efficiently.
We pride ourselves on offering a personalized service approach that meets your unique needs. Whether you need assistance with regulatory submissions or just routine quality control checks, we have the expertise needed to help you succeed.
International Acceptance and Recognition
- ISO 15376-4:2019: This standard provides requirements for determining tensile strength and elongation at break of stents intended for percutaneous transluminal coronary angioplasty (PTCA).
- EN ISO 15376-4:2019: European version of the same standard, ensuring compatibility with European regulatory frameworks.
- US FDA 21 CFR Part 820: Ensures that medical devices are safe and effective for their intended use. This includes requirements for design verification testing.
- International Standards Organization (ISO): A global standard organization recognized by governments, industry leaders, and other stakeholders worldwide, ensuring consistency across borders.
The acceptance of our services extends beyond national boundaries; we have successfully completed projects for clients from various countries including the United States, Canada, Europe, Asia-Pacific region, among others. Our commitment to excellence has earned us a reputation as one of the leading laboratories specializing in medical device testing globally.
