Ra Medical Systems today announced its Dabra 2.0 catheter received FDA 510(k) clearance.
The Carlsbad, California-based company designed the Dabra 2.0 catheter as part of its DABRA Excimer laser system. It has a braided over jacket design that improves deliverability and kink resistance when navigating tortuous anatomy.
“While we are pleased to receive this regulatory clearance, it comes as our board continues its evaluation of strategic alternatives to optimize our company’s path forward in the current challenging economic environment,” CEO Will McGuire said in a news release. “As we have previously announced, the Dabra 2.0 catheter represents an interim step in our work to develop a guidewire-compatible version of the Dabra catheter, and at this time we have no plans to commercialize the DABRA 2.0.”
Ra Medical’s Dabra excimer laser and catheters are indicated for the treatment of chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease and are intended for ablating a channel in occlusive peripheral vascular disease.
