ARTICLE SUMMARY:
Two key points along EBR Systems’ development of its novel WiSE CRT leadless heart failure device happened to line up with two of the biggest challenges faced by FDA’s device center in its history—the COVID-19 pandemic and recent mass layoffs. In both cases, CEO John McCutcheon says reviewers showed tremendous flexibility and resolve, and the system ultimately earned PMA approval April 11. The experience makes McCutcheon optimistic about CDRH’s future, despite current pressures.
A global pandemic during a pivotal trial. Unprecedented FDA staff layoffs in the final stage of submission review. These are, to say the least, not the events that a company dreams of when planning out its development path for a PMA device. But this was the hand dealt to EBR Systems on its approval route for the WiSE CRT System heart failure device.
Remarkably, while there were some delays, the firm’s original plans for the novel device made it through relatively unscathed when FDA granted approval April 11. John McCutcheon, EBR’s CEO, gives a lot of the credit to the agency, which at two different points along WiSE’s timeline was facing unprecedented resource and morale challenges internally, but nonetheless, he says, engaged his company with impressive flexibility and problem-solving resolve.
