The atherectomy clinical study has been granted investigational device exemption (IDE) approval from the US FDA, in January 2020
US-based medical device firm Ra Medical Systems has enrolled the first patient in clinical study of its DABRA excimer laser system for peripheral vascular stenoses.
DABRA is a minimally invasive excimer laser system designed for physicians to treat vascular blockages, both above and below the knee. The vascular blockages are caused due to lower extremity vascular disease, which is a form of peripheral artery disease (PAD).
Ra Medical claimed that its DABRA will reduce all plaque types to their fundamental chemical compounds, and dissolve the blockages without producing any harmful particulates.
The device is said to employ photoablation technology, which includes removal of arterial tissue using photons, to break the bonds of obstructing plaque and clear the blockages.
Ra Medical Systems CFO and interim CEO Andrew Jackson said: “We are committed to the successful commercialization of DABRA and we believe that initiating patient enrollment in this study is a significant step forward in achieving this goal.
“Furthermore, we have built a team of experienced, motivated and enthusiastic physician partners and employees to execute on this goal and we look forward to providing updates on our progress.”
Atherectomy clinical study will enrol up to 100 patients
Ra Medical said that the clinical study is aimed at evaluating the safety and effectiveness DABRA excimer laser system as an atherectomy device for the treatment of peripheral vascular stenosis.
The multicentre, open-label atherectomy clinical study has been granted investigational device exemption (IDE) approval from the FDA, in January 2020.
The study will enrol up to 100 patients with symptoms of PAD, to evaluate outcome measures including safety, acute technical success and clinical success.
The mean reduction in percent diameter stenosis in the primary lesion as measured by angiography, immediately after the treatment with DABRA, before any adjunctive treatment is the primary efficacy endpoint of the trial.
In addition, the safety and clinical success endpoints will be the major adverse events at 30 days and incidence of primary target lesion revascularisation (TLR) at six months.
Clinical study chairman Athar Ansari said: “My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device.
“We are thrilled to be the first center to begin enrollment in the atherectomy study, which represents an important next step in expanding the DABRA indications for use.”