Ra Medical Systems, Inc., a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces progress with finalizing the next-generation guidewire-compatible DABRA catheter design following a recent two-day, hands-on workshop with interventionalists who evaluated prototypes of the next-generation excimer laser catheter. DABRA is the company’s minimally invasive excimer laser system for the treatment of vascular blockages resulting from lower extremity vascular disease, a form of peripheral artery disease, or PAD.
The company also announces that enrollment in its pivotal atherectomy clinical trial with the DABRA excimer laser system is now at 62 subjects, including 42 subjects enrolled since the beginning of 2021. This trial is expected to enroll up to 100 subjects.
“I’m delighted Ra Medical Systems has made such significant forward progress in bringing a guidewire-compatible platform of their next-generation catheter to the market, while also advancing towards regulatory clearance for the atherectomy indication,” said Tom Davis, MD, an interventional cardiologist practicing at Eastlake Cardiovascular, P.C. “Achievement on both these milestones are critical and positive steps toward their commercialization success and represents a promising technology for expanded patient care options in my practice.”
“We are grateful for the valuable feedback we have received from our physician advisors as they are leaders in their field and represent the customer base for our excimer laser system,” said Will McGuire, Ra Medical Systems CEO. “Also, the current pace of enrollment in our atherectomy trial is encouraging, as we believe regulatory clearance for this indication will better position Ra Medical to address the large and growing market for treating vascular disease.”