Ra Medical Systems files 510(k) application for the catheter

Ra Medical Systems, Inc., a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces the filing of a 510(k) application with the U.S. Food and Drug Administration (FDA) for the company’s next-generation DABRA catheter with a braided overjacket and a six-month shelf life as a device for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease and with an intended use for ablating a channel in occlusive peripheral vascular disease. The overjacket design increases the overall catheter robustness for improved kink-resistance and trackability to better navigate tortuous anatomy.

“We are confident we’ve met our objective of designing a next-generation DABRA catheter that will allow physicians to better access difficult anatomy, which can be particularly challenging in the vasculature below the knee,” said Will McGuire, Ra Medical Systems CEO. “This 510(k) filing is a highly significant engineering and regulatory steppingstone toward our flagship commercial DABRA catheter, which will be a guidewire-compatible design.

“I’m proud of our team’s execution given the challenges they faced during these unprecedented times. I would like to thank the entire Ra Medical team and our physician partners who have helped us achieve this milestone,” he added. Business Wire