Ra Medical Systems has received CE mark approval for both the DABRA atherectomy system with catheter and the Pharos excimer laser to treat psoriasis, vitiligo and other skin diseases. The approval allows the devices to be sold in the European Union and all countries that recognise the CE mark.
“This is a major step forward for Ra Medical,” said co-founder and chief executive officer Dean Irwin. “Providing physicians with a safe, easy-to-use device that removes all types of plaque quickly is something my colleagues and I have been working on for over a quarter of a century. CE mark approval enables physicians around the world to choose the DABRA system that may be safer and more effective for their patients than other treatments, and DABRA’s economics may increase patient access for therapy.” The first DABRA cases in Europe are expected to be performed this year. Ra Medical is currently nearing completion of its US investigational device exemption study to support US Food and Drug Administration clearance.