Building Medical Device Innovations Together
~ Sr. Director of Regulatory & Clinical Affairs
In 2018, Integrity Implants was successfully commercializing FlareHawk in the US. Their next frontier was Europe and they needed a CE mark. Integrity had an aggressive timeline of months, not years, to get an EU clearance for their flagship product.
Since FlareHawk is a uniquely-designed interbody fusion cage, the typical approach that manufacturers use for demonstrating equivalence to competitive products and leveraging their published clinical data was not an option. Integrity needed original, quality clinical evidence on the FlareHawk device…fast.
In late 2018, Integrity engaged Telos to plan and execute a clinical study to gather data to support a CE Mark.
Telos jumped into action and put together a plan for a retrospective study to collect US post-market clinical data that included:
Telos then used their expertise and integrated approach to also assist Integrity:
There are always hiccups along the way and clinical studies were new ground for Integrity. Telos provided the proper guidance and corrective actions at each site to ensure an adequate amount of high-quality data was collected through the process.
It was an astonishing feat, but the study was completed within an aggressive deadline. Integrity expects to receive the CE Mark soon.