Pre-Market Case Study

Medpace helps accelerate submission and approval for a non-implantable cardiac device

The 510(k) was submitted at an accelerated 48 days after last patient out, significantly outpacing the typical 90-120 days for submission

This medical device company seeking FDA approval for a non-implantable cardiac device partnered with Medpace Medical Device for this full-service study that spanned protocol design strategy through preparation and submission of the final 510(k) report.

Challenges

The device itself posed a unique challenge because it was a novel device that would only be available in a limited number of hospitals and few physicians had ever worked with it. To identify, treat and follow up with subjects, multiple subspecialties within cardiology had to be involved in the study—including interventional cardiologists and electrophysiologists—creating scheduling difficulties and more challenging communication paths among the cardiologists and with the study team.