Challenge

During premarket review of a long-term implantable device, regulatory agencies raised concerns about the clinical stability of a polyether-block amide (PEBA) component used in the device’s outer housing.
Citing potential long-term degradation mechanisms (e.g., hydrolytic breakdown), the agencies requested justification that the material would remain stable and biocompatible over the device’s intended duration in vivo.

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Chemva’s Solution

Chemva led a detailed material-specific risk assessment, supported by both scientific literature and historical clinical use.
PEBA is a well-characterized thermoplastic elastomer with a long-standing record of use in various medical applications, including catheters and implantable leads, often in dynamic or moist environments. We consolidated the following data into a cohesive scientific justification:

• Physicochemical data confirming PEBA’s resistance to hydrolysis and oxidation under physiological conditions.
• Extractables studies showing no extracted compounds that could be associated with degradation products over accelerated aging.
• Clinical and post-market use history of similar formulations used in long-term implants without reported material failures or degradation-related complications.

We contextualized these findings in the Biological Evaluation Report (BER) and a targeted Degradation Assessment report, directly addressing ISO 10993-9 and ISO 10993-13 requirements for chemical stability and risk assessment of degradation products.

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Impact Delivered

Chemva’s comprehensive, science-backed approach satisfied regulatory concerns without requiring additional in-vitro degradation studies.
The submission was cleared without delay, saving our partner an estimated 6–9 months in development time and $250,000 in potential testing costs.