Reflow’s system obtained breakthrough device designation in the US four years ago. Image credit: Reflow Medical.

Reflow Medical has completed enrollment in a clinical trial evaluating its retrievable stent for the treatment of vascular lesions in the infrapopliteal arteries below the knee.

The US cardiovascular device specialist’s senior vice president of research and development Teo Jimenez said Reflow’s next step is to gather the necessary follow-up data required for US approval.

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The device, named Reflow Spur Stent, already gained CE marking in Europe earlier this year.

The DEEPER REVEAL trial (NCT05358353) enrolled 130 patients across 35 sites in the US who have stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels and who are eligible for surgery.

Intended for patients with critical limb-threatening ischemia (CLTI), Reflow’s device aims to produce stent-like results without leaving a metal framework behind. Stents usually act as a wire mesh scaffold to keep vessels open. In successful cases, they are permanently implanted devices.

Reflow’s Reflow Spur stent has self-expanding spikes that create pathways for increased uptake of antiproliferative drugs into the vessel wall. After treating the vessel, the device is removed using a commercially available drug-coated balloon. This approach to treating diseased vessels is known as retrievable stent therapy (RSP).

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Reflow is testing its Bare temporary system in the trial. The primary efficacy endpoint is assessing the degree of residual stenosis in patients treated with the device. The trial also has a co-primary safety endpoint of freedom from the occurrence of major adverse limb events up to 30 days post-procedure.

Reflow’s system obtained breakthrough device designation from the US Food and Drug Administration in 2020, meaning the company is eligible for prioritised review and enhanced feedback during the premarket phase.

The global peripheral vascular stent market was worth $1.8bn last year and is expected to grow to $3.6bn by 2033, according to analysis by GlobalData.