Reflow’s Spur Stent System Evaluated for CLTI in 12-Month DEEPER REVEAL Data

April 13, 2026—Reflow Medical, Inc. announced 12-month results from the DEEPER REVEAL clinical trial.

According to the company, the prospective nonrandomized, multicenter study is evaluating the company’s Spur peripheral retrievable stent system after predilatation in patients with chronic limb-threatening ischemia (CLTI) and below-the-knee (BTK) arterial disease. The DEEPER REVEAL trial enrolled 130 patients at 49 centers in the United States.

Constantino Peña, MD, presented the data at SIR 2026, the Society of Interventional Radiology’s annual scientific meeting in Toronto, Canada. In the 12-month data, 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,” commented Dr. Peña in the Reflow Medical press release. “At 12 months, we observed primary patency of 78% and freedom from clinically driven target lesion revascularization of 83.1% in appropriately sized target vessels.”

The company further stated that patient-centered outcomes improved from baseline, including complete paired wound healing in 84.3% of patients, symptomatic improvement measured by Rutherford class in 80% of patients, and significant gains in vascular quality of life.

Dr. Peña stated, “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.”

In May 2025, Reflow Medical announced FDA de novo clearance for the Spur stent system in a high-risk, long-lesion population.