What's Happening?
Reflow Medical, Inc., a developer of medical devices for cardiovascular disease, has announced the 12-month results from the DEEPER REVEAL clinical trial. The trial evaluated the Spur Peripheral Retrievable Stent System in patients with chronic limb-threatening
ischemia (CLTI) and below-the-knee (BTK) arterial disease. Conducted across 49 U.S. centers, the study involved 130 patients. The results, presented at the Society of Interventional Radiology 2026 Annual Scientific Meeting, showed a primary patency rate of 78.0% and freedom from clinically driven target lesion revascularization of 83.1% in appropriately sized target vessels. Patient-centered outcomes also improved, with complete wound healing in 84.3% of patients and symptomatic improvement in 80.0% of patients. The Spur Stent System, which received FDA De Novo clearance in May 2025, provides temporary mechanical scaffolding to support vessel walls and facilitate blood flow.
Why It's Important?
The positive results from the DEEPER REVEAL trial highlight the potential of the Spur Stent System as a valuable treatment for patients with severe CLTI and complex BTK disease. This condition represents the most advanced stage of peripheral arterial disease, associated with high morbidity, mortality, and limb loss. The trial's findings suggest that the Spur Stent System could offer a significant improvement over traditional balloon angioplasty, providing a new option for physicians treating complex BTK disease. The success of this trial supports Reflow Medical's efforts to expand access to innovative treatment options, addressing a significant unmet need in cardiovascular care.
What's Next?
Following the successful trial results, Reflow Medical aims to expand access to the Spur Stent System for physicians treating complex BTK disease. The company plans to leverage the Breakthrough Device Designation and FDA De Novo clearance to further develop and distribute the Spur Stent System. This could lead to broader adoption of the technology in clinical practice, potentially improving outcomes for patients with CLTI. Continued research and development may focus on enhancing the device's capabilities and exploring its use in other cardiovascular conditions.
