The braided overjacket design of the next-generation DABRA catheter with a six-month shelf life is intended to increase deliverability and kink resistance when crossing convoluted anatomy
Ra Medical Systems has received the US Food and Drug Administration 510(k) clearance for its DABRA 2.0 catheter as part of the DABRA Excimer Laser System.
The braided overjacket design of the next-generation DABRA catheter with a six-month shelf life is intended to increase deliverability and kink resistance when crossing convoluted anatomy.
According to the firm, the DABRA catheter provides a clean, concentric lumen while reducing trauma to the vasculature.
The DABRA catheter features a 150cm operating length and a 1.5mm blunt-tip design.
DABRA reduces the risk of vascular damage that might be caused by the mechanical mode of action employed by rival devices by removing plaque using photoablation.
Ra Medical conducted a non-randomised, prospective, and multi-site study to study the safety and effectiveness of the DABRA laser system and disposable DABRA catheter.
It evaluated the lesion crossing by way of plaque photoablation using DABRA in the endovascular treatment of vascular blockages resulting from lower extremity vascular disease.
The study recruited 64 subjects at four sites with both above-the-knee and below-the-knee lesions. Ra Medical said that 50 subjects were included in the data submitted to the FDA.
The final study results revealed 94% effectiveness with 0% reported device-related SAEs, both related to the 50 subjects included in the data submitted to the FDA and the 64 subjects who participated in the study.
Ra Medical Systems CEO Will McGuire said: “While we are pleased to receive this regulatory clearance, it comes as our Board continues its evaluation of strategic alternatives to optimise our company’s path forward in the current challenging economic environment.
“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.”
In June 2019, the company started a study to show the effectiveness of the DABRA Excimer Laser System for effective, long-lasting results and a low reintervention rate for patients with peripheral artery disease (PAD).