Reflow Medical Receives FDA De Novo Clearance for Spur Stent System, Marking a Breakthrough in Treatment of Below-the-Knee Peripheral Arterial Disease
Reflow Medical, Inc., a pioneering company in the development of advanced medical devices for complex cardiovascular conditions, has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for its Spur Peripheral Retrievable Stent System. This milestone marks a significant achievement for both Reflow Medical and the field of peripheral arterial disease (PAD), as the Spur System is now the first and only retrievable stent system approved by the FDA specifically designed for patients with infrapopliteal arterial disease—commonly referred to as below-the-knee (BTK) peripheral artery disease.
The clearance provides a much-needed clinical tool for the treatment of de novo (new) or restenotic (re-narrowed) arterial lesions that persist even after predilatation. These types of lesions are often observed in patients with chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease that can lead to pain, tissue damage, and limb amputation if left untreated.
Spur Stent System: A Novel Mechanism in PAD Treatment
The Spur FDA Peripheral Retrievable Stent System stands out as a first-of-its-kind mechanical solution that combines a self-expanding stent and a balloon catheter on an over-the-wire system. Unlike traditional stents that remain permanently implanted, the Spur system is retrievable, offering a more flexible and potentially safer approach to treatment.
A central feature of the Spur device is its radially expandable spikes, a mechanism referred to as Retrievable Scaffold Therapy (RST). These spikes are engineered to penetrate the lesion, increase acute luminal diameter, and alter lesion morphology. The result is improved vessel compliance and a significant reduction in vessel recoil, which often undermines the long-term success of traditional balloon angioplasty in BTK interventions.
By addressing the structural issues within the arterial wall and not just compressing the plaque, the Spur system offers a more comprehensive treatment approach, modifying both the lumen and vessel wall mechanics to improve blood flow in the affected area.
Clinical Validation Through DEEPER REVEAL Trial
The FDA’s decision to grant De Novo clearance was strongly supported by compelling data from the DEEPER REVEAL clinical trial (ClinicalTrials.gov Identifier: NCT05358353). This pivotal study was designed to evaluate the performance, safety, and effectiveness of the Spur Stent System in treating BTK lesions in patients suffering from CLTI.
Conducted across 49 U.S. clinical sites and involving 130 patients, the trial results were striking. Key highlights include:
- A technical success rate of 99.2%, demonstrating that the device could be consistently and reliably deployed and retrieved as intended.
- A 97.0% freedom from major adverse limb events (MALE) and procedural-related death (POD) at 30 days, underscoring the safety profile of the technology.
These FDA results surpassed standard outcomes typically associated with balloon angioplasty alone and suggest that the Spur system can significantly enhance clinical results for patients with complex vascular disease.
Physician Leaders Applaud Innovation and Results
Two of the lead principal investigators of the DEEPER REVEAL study—Dr. Mahmood K. Razavi and Dr. S. Jay Mathews—expressed strong support for the FDA’s clearance decision and the promise the device holds for patient care.
Dr. Razavi, who serves as Director of the Clinical Trials and Research Center at St. Joseph Heart and Vascular Center in Orange, California, remarked on the importance of the device’s novel mechanism. “Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System,” he said. “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, Cath Lab Director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Florida, echoed that sentiment. “It’s exciting to see the clinical success of the DEEPER REVEAL trial enabling the De Novo clearance of the Spur Stent System,” he noted. “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 outcomes that go beyond what PTA (percutaneous transluminal angioplasty) alone can deliver.”
Bridging Innovation and Execution
Behind the scenes, Reflow Medical’s internal research and development team played a critical role in bringing the Spur Stent System to life. Teo Jimenez, Senior Vice President of Research & Development at Reflow Medical, reflected on the rigorous engineering and clinical processes that led to the device’s success.
“Extensive research and development, which laid the groundwork for the DEEPER REVEAL trial, enabled the FDA creation and clinical validation of the Spur Stent System,” Jimenez said. “This is an innovative mechanical endovascular device engineered to enhance lesion penetration and optimize the treatment of BTK peripheral arterial disease.”
This FDA balance between mechanical innovation and clinical applicability is what sets the Spur system apart, offering a treatment option that is both effective and uniquely suited for difficult-to-treat BTK lesions.
Readiness for Market Launch
Reflow Medical’s CEO and Co-Founder Isa Rizk emphasized the company’s readiness to bring this novel therapy to patients across the United States. “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,” Rizk stated.
He added that the company has already developed a strong commercialization infrastructure and is prepared for a nationwide rollout of the Spur Stent System through its dedicated sales force. “We are fully prepared to launch our innovative technology, ensuring it promptly reaches physicians to support patients.”
This is particularly relevant as the number of patients with chronic limb-threatening ischemia continues to rise, driven in part by an aging population and increasing rates of diabetes and cardiovascular disease.
Regulatory Recognition
The FDA’s official documentation of the De Novo classification for the Spur Peripheral Retrievable Stent System is available under DEN240048 on the FDA’s website. This classification underscores the device’s novelty and the lack of an existing predicate device, further cementing its status as a first-in-class therapy.
The De Novo pathway is reserved for medical devices that are low to moderate risk but have no substantially equivalent device currently on the market. This clearance signifies the FDA’s recognition of the Spur system as a groundbreaking tool that fills an unmet clinical need.
The FDA’s De Novo clearance of the Spur Peripheral Retrievable Stent System represents a significant leap forward in the treatment of below-the-knee peripheral artery disease, especially for patients with chronic limb-threatening ischemia. With its ability to improve lesion morphology, reduce vessel recoil, and offer retrieval flexibility, the Spur system delivers a highly targeted, mechanical approach that expands the therapeutic possibilities beyond balloon angioplasty alone.
Backed by rigorous clinical evidence from the DEEPER REVEAL trial and supported by leading vascular specialists, Reflow Medical’s Spur system is poised to transform the treatment landscape for one of the most challenging and debilitating forms of vascular disease.
As the company prepares for commercial deployment, physicians and patients alike may soon benefit from a new standard of care that prioritizes innovation, precision, and safety in the fight against CLTI and peripheral artery disease.
