Reflow Medical Announces 12-Month Results from DEEPER REVEAL Trial

Sustained Outcomes with the Spur® Stent System in CLTI

Apr. 14, 2026 at 2:43am

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An extreme close-up X-ray photograph showing the delicate, intricate internal structure of a medical stent device, its intricate lattice of metal struts and channels glowing against a dark background, conceptually illustrating the advanced engineering behind this new treatment for complex cardiovascular disease.Cutting-edge medical imaging technology provides a detailed look at the innovative design of the Spur® Stent System, a promising new treatment for severe peripheral artery disease.San Clemente Today

Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, has announced that 12-month results from the DEEPER REVEAL clinical trial (NCT05358353) were presented for the first time at the Society of Interventional Radiology Annual Scientific Meeting. The results demonstrate sustained clinical outcomes in a challenging population of patients with severe chronic limb-threatening ischemia (CLTI) and complex below-the-knee (BTK) disease.

Why it matters

The DEEPER REVEAL trial evaluates the long-term performance of Reflow Medical's Spur® Stent System, a novel device designed to treat complex BTK disease, which is a leading cause of CLTI and lower limb amputations. Positive 12-month results indicate the potential for the Spur® Stent System to provide durable treatment options for this high-risk patient population.

The details

The DEEPER REVEAL trial is a prospective, multicenter, single-arm study that enrolled 120 patients with severe CLTI and complex BTK disease. The 12-month results showed sustained improvements in wound healing, limb salvage, and quality of life measures, suggesting the Spur® Stent System may offer a promising treatment approach for this challenging patient population.

  • The DEEPER REVEAL clinical trial (NCT05358353) was conducted in 2025.
  • The 12-month results from the trial were presented on April 14, 2026 at the Society of Interventional Radiology Annual Scientific Meeting.

The players

Reflow Medical, Inc.

A leading developer of innovative medical devices focused on complex cardiovascular disease.

Spur® Stent System

A novel device designed by Reflow Medical to treat complex below-the-knee (BTK) disease, a leading cause of chronic limb-threatening ischemia (CLTI) and lower limb amputations.

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The takeaway

The positive 12-month results from the DEEPER REVEAL trial suggest the Spur® Stent System may offer a promising treatment option for patients with severe CLTI and complex BTK disease, potentially helping to reduce the risk of lower limb amputations in this high-risk population.