Sam Brusco, Associate Editor07.05.22
Ra Medical Systems has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its DABRA 2.0 catheter as part of its DABRA excimer laser system.
The next-gen catheter features a braided overjacket design to improve deliverability and kink resistance when navigating tortuous anatomy. It also touts a six-month shelf life.
“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,” Will McGuire, Ra Medical Systems CEO told the press. “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.”
The company recently reduced its workforce by about 65% as well.
The next-gen catheter features a braided overjacket design to improve deliverability and kink resistance when navigating tortuous anatomy. It also touts a six-month shelf life.
“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,” Will McGuire, Ra Medical Systems CEO told the press. “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.”
The company recently reduced its workforce by about 65% as well.