Reflow Medical Spur Stent System Granted FDA De Novo Clearance

May 29, 2025—Reflow Medical, Inc. announced that the FDA has granted de novo clearance for the company’s Spur peripheral retrievable stent system for the treatment of de novo or restenotic lesions after predilatation in patients with infrapopliteal arterial disease.

According to Reflow Medical, the Spur stent system features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes.

Known as Retrievable Scaffold Therapy (RST), the spikes on the Spur stent penetrate the lesion to increase acute luminal diameter and modify lesion morphology to change vessel compliance and reduce vessel recoil effect, stated Reflow Medical.

As noted in the company press release, the DEEPER REVEAL clinical trial evaluated the Spur stent system for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI). The study enrolled 130 patients at 49 centers in the United States.

The recently concluded study demonstrated that after predilatation, the Spur stent system achieved a 99.2% technical success rate and 97% freedom from major adverse limb events and perioperative death at 30 days, reported the company.

Mahmood K. Razavi, MD, and S. Jay Mathews, MD, served as lead Principal Investigators for the DEEPER REVEAL study.

“Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur stent system,” commented Dr. Razavi in Reflow Medical’s press release. “This novel device will be a valuable and innovative expansion of our treatment toolbox as a unique device for the treatment of complex BTK disease.”

Dr. Mathews added, “It’s exciting to see the clinical success of the DEEPER REVEAL trial enabling the de novo clearance of the Spur stent system. This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease.”

Dr. Mathews continued, “As an adjunct to standard balloon angioplasty, Spur RST enables us to address this complex disease in a more effective way, achieving these outcomes that go beyond what percutaneous transluminal angioplasty alone can deliver.”