Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announces that 12-month results from the DEEPER REVEAL clinical trial (NCT05358353) were presented for the first time today at the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting in Toronto, Canada.
The data was presented by Constantino Peña, MD, FSIR, FSVM, on behalf of the study’s Principal Investigators, Mahmood K. Razavi, MD, FSIR, FSVM; S. Jay Mathews, MD, MS, FACC, FSCAI; Jihad A. Mustapha, MD, FACC, FSCAI, and the DEEPER REVEAL trial investigators.
DEEPER REVEAL is a prospective, non-randomized, multicenter study evaluating use of the Spur Peripheral Retrievable Stent System following predilatation in patients with chronic limb-threatening ischemia (CLTI) and below-the-knee (BTK) arterial disease. 130 patients are enrolled across 49 U.S. centers. In May 2025, the Spur Stent System was granted FDA De Novo clearance in a high-risk, long-lesion population.
At 12 months, vessel-related outcomes in appropriately selected vessels (core-lab measured reference vessel diameter ≥2.5 mm, as defined per study protocol and indication for use) and patient-centered outcomes were assessed.
“These 12-month results demonstrate sustained clinical outcomes in a challenging population of patients with severe CLTI and complex BTK disease,” said Dr. Peña. “At 12 months, we observed primary patency of 78.0% and freedom from clinically driven target lesion revascularization of 83.1% in appropriately sized target vessels.”
Patient-centered outcomes improved from baseline, including complete paired wound healing in 84.3% of patients, symptomatic improvement measured by Rutherford class in 80.0% of patients, and significant gains in vascular quality of life.
Dr. Peña continued, “Importantly, these findings compare favorably to well-established historical plain balloon angioplasty data and support the role of Retrievable Scaffold Therapy with the Spur Stent System as a valuable treatment approach in this high-risk population.”
The Spur Stent System is a unique clinical solution for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease. It provides temporary mechanical scaffolding to support the vessel wall and facilitate blood flow. The Spur stent incorporates radially expandable spikes for controlled lesion penetration and modification, improving vessel compliance and reducing vessel recoil. Following treatment, the device is fully retrieved, preserving future treatment options.
“The DEEPER REVEAL 12-month results reinforce the clinical value of Reflow Medical’s Retrievable Scaffold Therapy in addressing the significant unmet need in patients with CLTI,” said Carolyn Mascho, Director of Clinical Affairs at Reflow Medical.
According to Isa Rizk, CEO and Co-Founder of Reflow Medical, “Building on the Breakthrough Device Designation and FDA De Novo clearance for Spur, these data support our efforts to expand access to innovative treatment options for physicians treating complex BTK disease.”
CLTI represents the most advanced stage of peripheral arterial disease and is associated with high morbidity, mortality, and limb loss. Patients with BTK disease often present with complex lesions and limited treatment options.
