Reflow Medical announced that the U.S. Food and Drug Administration has granted De Novo clearance for the company's Spur Peripheral Retrievable Stent System, marking a significant advancement in the treatment of infrapopliteal arterial disease. The device represents the first and only retrievable stent system designed for treating de novo or restenotic lesions following predilatation in patients with below-the-knee arterial disease.
Revolutionary Retrievable Scaffold Technology
The Spur Stent System features a unique design that combines a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. The device employs Retrievable Scaffold Therapy (RST), utilizing a series of radially expandable spikes that penetrate lesions to increase acute luminal diameter and modify lesion morphology. This mechanism changes vessel compliance and reduces vessel recoil effect, offering a novel approach to endovascular treatment.
Clinical Trial Results Demonstrate Strong Efficacy
The FDA clearance was supported by results from the DEEPER REVEAL clinical trial (NCT05358353), which evaluated the Spur Stent System for below-the-knee treatment of chronic limb-threatening ischemia (CLTI). The multicenter study, conducted at 49 centers across the United States and enrolling 130 patients, demonstrated impressive clinical outcomes.
Following predilatation, the Spur Stent System achieved a 99.2% technical success rate, defined as less than 30% residual stenosis by visual estimation. Additionally, the trial showed 97.0% freedom from major adverse limb events (MALE) and perioperative death (POD) at 30 days.
Expert Perspectives on Clinical Impact
"Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System," said Mahmood K. Razavi, MD, FSIR, FSVM, Director of the Clinical Trials and Research Center at St. Joseph Heart and Vascular Center in Orange, California. "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."
S. Jay Mathews, MD, MS, FACC, FSCAI, Cath Lab Director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Florida, emphasized the clinical significance of the technology. "This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease. 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 PTA alone can deliver."
Both Dr. Mathews and Dr. Razavi served as lead Principal Investigators for the DEEPER REVEAL study.
Company Leadership and Market Readiness
Teo Jimenez, Senior Vice President of R&D at Reflow Medical, highlighted the extensive development process behind the technology. "Extensive research and development, which laid the groundwork for the DEEPER REVEAL trial, enabled the creation and clinical validation of the Spur Stent System, an innovative mechanical endovascular device engineered to enhance lesion penetration and optimize the treatment of BTK peripheral arterial disease."
Isa Rizk, CEO and Co-Founder of Reflow Medical, expressed the company's readiness for market launch. "The FDA's De Novo clearance, following positive clinical trial results in patients with CLTI, enables us to provide physicians with an effective therapeutic option for this growing patient population. We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients."
Regulatory and Market Context
The FDA decision is available on their website under designation DEN240048. The Spur device previously received CE Mark approval for the treatment of restenotic lesions in below-the-knee arteries when used in conjunction with a commercially available drug-coated balloon.
Reflow Medical, headquartered in San Clemente, California, develops innovative technologies addressing unmet clinical needs in endovascular treatment of complex cardiovascular disease. The company's portfolio includes coronary and peripheral microcatheters, crossing catheters, and the revolutionary Retrievable Scaffold Therapy system.
