Reflow Medical Discloses Encouraging Study Results for its Spur Stent System

Reflow Medical Inc. is sharing positive 12-month clinical trial results showing its Spur Peripheral Retrievable Stent System helped improve wound healing and symptoms in patients with chronic limb-threatening ischemia (CLTI) and below-the-knee (BTK) arterial disease.

The DEEPER REVEAL study’s principal investigators include Mahmood K. Razavi, M.D.; S. Jay Mathews, M.D.; and Jihad A. Mustapha, M.D. DEEPER REVEAL is a prospective, non-randomized, multicenter study evaluating the Spur Peripheral Retrievable Stent System after predilatation in CLTI and BTK arterial disease patients. Investigators enrolled 130 patients across 49 U.S. centers.

Last May, the Spur Stent System earned U.S. Food and Drug Administration De Novo clearance in a high-risk, long-lesion population.

DEEPER REVEAL assessed 12-month 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 results. 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.

“These 12-month results demonstrate sustained clinical outcomes in a challenging population of patients with severe CLTI and complex BTK disease,” said Constantino Peña, M.D. “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. 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 clinical solution for treating de novo or restenotic lesions after 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. After 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,” Reflow Medical Clinical Affairs Director Carolyn Mascho stated.

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.

“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,” Reflow Medical Co-Founder/CEO Isa Rizk said.

Reflow Medical is a global firm that partners with physicians to develop technologies addressing unmet clinical needs in the endovascular treatment of complex cardiovascular disease. The company’s portfolio includes coronary and peripheral microcatheters, crossing catheters, and its proprietary Retrievable Scaffold Therapy (RST) platform. The coronary Cora Catheters line is approved by the U.S. Food and Drug Administration (FDA). The peripheral product line includes Wingman, Spex, Spex LP, and Spur, which have FDA clearance and CE Mark registration. Reflow Medical is headquartered in San Clemente, Calif.