DABRA is a minimally invasive excimer laser system designed for endovascular treatment of vascular blockages above and below the knee
Ra Medical Systems secures FDA IDE approval for Atherectomy clinical study. (Credit: Pixabay/valelopardo)
Ra Medical Systems has secured the US Food and Drug Administration (FDA) approval to start an investigational device exemption (IDE) study of the DABRA excimer laser system for the treatment of peripheral vascular stenosis.
The medical device company has received FDA 510(k) approval of DABRA for ablating a channel in occlusive peripheral vascular disease (PAD), in May 2017.
Ra Medical Systems CFO and Interim CEO Andrew Jackson said: “We are delighted the FDA has granted this IDE allowing us to pursue an atherectomy indication for DABRA and anticipate enrolling the first patient into the trial in the next few months.
“We believe DABRA produces minimal vascular trauma due to its unique use of photochemical ablation that dissolves plaque into its molecular components, which may make DABRA a preferred treatment. Atherectomy with mechanical devices can cause trauma to vessel walls, often resulting in restenosis or a return of the blockage months following the procedure.”
DABRA is a minimally invasive excimer laser system
The multicentre, open-label IDE trial is designed enrol up to 100 patients with PAD symptoms, to evaluate the safety, acute technical success and clinical success of the DABRA excimer laser system.
DABRA is a minimally invasive excimer laser system designed as a tool in the endovascular treatment of vascular blockages due to lower extremity vascular disease, a type of PAD, above and below the knee.
The device is said to reduce all four types of plaque into proteins, lipids and other chemical compounds, and eliminate blockages by dissolving them without generating harmful particulates by employing photochemical ablation.
In addition, the device would photochemically dissolve the plaque with minimal vascular trauma, unlike other PAD treatments that cause damage to the arterial wall.
The primary efficacy endpoint of the study is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography, immediately after treatment with DABRA, before any adjunctive treatment.
Safety and clinical success endpoints of the trial include major adverse events reported at 30 days and occurrence of primary target lesion revascularization (TLR) at six months.