Cardiovascular implant with biological tissue

Why:

This case study aims to address irregular (but expected) results in biocompatibility testing faced by a company developing a cardiovascular product containing an animal-origin component (biological heart valve). The results could have been a major issue in obtaining FDA Investigational Device Exemption (IDE) approval, delaying the clinical trials and resulting in significant costs and time investment.

For Whom:

The case study is designed for the medical device manufacturer dealing with products that have an animal-origin material and those seeking FDA approval.

How:

The biocompatibility experts were involved to assess all the available results and design a strategic approach to tackle the issues.

The following steps were taken to address the challenges:

1. Overall assessment of results considering ISO 10993-18 and ISO 10993-17: The experts analysed the testing results and identified the potential causes. Through their comprehensive analysis, we provided the required justifications for these results and the root cause was identified.

2. Optimisation of the cleaning process: The cleaning/conditioning process required before implantation was challenged and it was optimised to reduce the residues of storage mixture. This step was crucial in safety assessment as these residues are considered very toxic and could interfere with the chemical characterisation.

3. Selection of an appropriate extraction method for the chemical characterisation: The initial extraction method led to high variability in test results. We designed a more suitable extraction method that increased consistency in the testing results.

4. FDA IDE submission: Every step was rationalised, and a full comprehensive report was submitted to the FDA as part of the IDE submission.

5. Participation in the FDA meeting: We actively participated in the FDA meetings answering any queries or concerns raised by the regulatory authority. Our presence and expertise significantly contributed to the acceptance of the rationalisations and results, saving the company from doing a full battery of biological tests which would require a lot of time and additional budget.

Outcomes:

The outcome was highly positive as the company obtained the IDE Approval. The company was able to expedite the clinical trials, accelerating the development and potential commercialisation of their cardiovascular product.