Ra Medical Systems has secured approval from the US Food and Drug Administration (FDA) for its catheter-and-laser atherectomy system to treat peripheral artery disease (PAD).
The company’s DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) atherectomy system is used with catheter to treat complex and diffuse arterial blockages in the lower vessels.
The single-use catheter will track the true lumen without a guidewire and will avoid to reach subintimal.
It can be used with introducers, sheaths, and guide catheters, operated ipsilateral and contralateral, and antegrade and retrograde.
DABRA laser, which is the excimer laser power source for DABRA catheters, will generate 308-nm UVB photons that can photochemically ablate arterial blockages.
Ra Medical’s DABRA has a shorter procedure time compare to other treatments for arterial blockages.
Ra Medical Systems Dean Irwin said: “DABRA’s U.S. market clearance is the realization of more than a decade of dedication to the pursuit of delivering a more effective, safer, and less expensive way to remove blockages from arteries to save limbs and, ultimately, save lives.
“To do so, we built Ra Medical Systems and pioneered our cost-effective, small, and portable Pharos Excimer Laser for dermatological diseases, thereby creating our company infrastructure and self-funding the development of DABRA.”
In October 2016, Ra Medical Systems had secured CE mark approval for both the DABRA atherectomy system with catheter and Pharos excimer laser to treat psoriasis, vitiligo and other skin diseases.
Established in 2002, Ra Medical is engaged in the commercialization of excimer lasers and catheters to treat dermatologic and cardiovascular diseases.
Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.