Reflow Medical Reports Positive 12-Month Results from DEEPER REVEAL Trial

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-randomised, multicenter study evaluating the 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. centres. 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-centred 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 per cent and freedom from clinically driven target lesion revascularisation of 83.1 per cent in appropriately sized target vessels.”

Patient-centred outcomes improved from baseline, including complete paired wound healing in 84.3 per cent of patients, symptomatic improvement measured by Rutherford class in 80.0 per cent of patients, and significant gains in vascular quality of life.

Dr Peña continued, “Importantly, these findings compare favourably 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.”