Ra Medical Systems has secured the US Food and Drug Administration (FDA) clearance to begin investigational device exemption (IDE) to study its DABRA excimer laser system as an atherectomy device to treat peripheral vascular stenoses.
DABRA system eliminates blockages from arteries in the limbs and is efficient on all types of lesions.
In addition to altering the arteries, DABRA can bypass the lesion and cross the chronic total occlusions (CTOs) with a wire.
During the trial, 100 patients will be registered with symptoms of peripheral vascular disease (PAD) (Rutherford Class 2-4).
The principal efficacy endpoint of the study is the mean decrease in diameter stenosis in patients’ primary lesion following DABRA treatment before adjunctive treatment.
The safety and clinical success endpoints for the study is characterised by main adverse events during 30 days and the occurrence of primary target lesion revascularisation at six months.
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.”
In May 2017, Ra Medical Systems had secured approval from the US FDA to market its laser radiation ablation (DABRA) system to treat peripheral artery disease (PAD).