What's Happening?
Reflow Medical, Inc., a company specializing in medical devices for cardiovascular diseases, has announced the 12-month results of its 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 arterial disease. Conducted across 49 U.S. centers with 130 patients, the study showed promising outcomes. The Spur Stent System, which received FDA De Novo clearance in May 2025, demonstrated a primary patency rate of 78.0% and freedom from clinically driven target lesion revascularization of 83.1% in appropriately sized target vessels. The trial results were presented at the Society of Interventional Radiology 2026 Annual Scientific Meeting in Toronto.
Why It's Important?
The results of the DEEPER REVEAL trial are significant as they offer a new treatment option for patients with severe CLTI, a condition associated with high morbidity and mortality. The Spur Stent System provides a temporary mechanical scaffold to support blood flow, which is crucial for patients with complex lesions and limited treatment options. The positive outcomes could lead to broader adoption of this technology, potentially improving patient quality of life and reducing healthcare costs associated with limb loss and other complications. The trial's success also reinforces Reflow Medical's position as a leader in developing innovative cardiovascular solutions.
What's Next?
Following the positive trial results, Reflow Medical may seek to expand the use of the Spur Stent System in other high-risk patient populations. The company might also pursue further regulatory approvals and explore partnerships to enhance the system's market reach. Additionally, ongoing research and development efforts could lead to improvements in the stent system, making it more effective and accessible to a wider range of patients.
