Medical excimer laser developer Ra Medical said today it won CE Mark approval in the European Union for both its Dabra artherectomy catheter system and its Pharos excimer laser designed to treat skin diseases.
The Carlsbad, Calif.-based company said the 1st patients are slated to be treated with the Dabra system this year, and said it is nearing completion of an investigational device exemption study in support of FDA clearance in the U.S.
Ra Medical’s Pharos excimer laser system is designed for treating psoriasis, vitiligo and other skin diseases, the company said.
“This is a major step forward for Ra Medical. 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 Marking approval enables physicians around the world to choose the Dabra system that may be safer and more effective for their patients than other treatments. The Dabra’s economics may increase patient access for therapy,” co-founder & CEO Dean Irwin said in a press release.