Medtronic has started an investigational device exemption (IDE) study to assess its Abre venous self-expanding stent system in patients suffering from deep venous disease.
Abre is an investigational device being developed for permanent implant in the iliofemoral vein. The device includes a nitinol stent with a tri-axial shaft design, and uses optimised strength and flexibility to exert an outward force for opening the obstructed vein.
To ensure flexibility and conformability, the stent features an open-cell design with three connection points between the cells.
The multi-centre, single-arm ABRE IDE Study will investigate the safety and effectiveness of the stent in 200 patients with iliofemoral venous outflow obstruction at up to 35 clinical sites in the US and Europe.
ABRE IDE Study European principal investigator Stephen Black said: “Deep venous disease can cause pain, swelling, and blood clots, which can potentially be devastating to patients.
“As a result, there is a critical need for treatment options that are safe, effective, and durable.
“We look forward to using the Abre stent in the restoration of patency in patients with deep venous disease.”
The primary efficacy endpoint of the study is patency at 12 months defined as freedom from occlusion and clinically driven target lesion revascularisation (CD-TLR).
The study will also monitor the incidence of composite major adverse events (MAE) at 30 days after stenting an obstruction in the iliofemoral vein as the primary safety endpoint.
Medtronic expects that the findings from this study will support its US pre-market approval (PMA) application of the Abre stent to treat symptomatic iliofemoral venous outflow obstruction in venous occlusive disease.