Reflow Medical recently announced that the US Food and Drug Administration (FDA) has granted de novo clearance for the company’s Spur peripheral retrievable stent system, which is designed for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease.
According to Reflow Medical, the Spur stent system is the first and only retrievable stent system that 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 the acute luminal diameter and modify the lesion morphology to change vessel compliance and reduce vessel recoil effect.
Results of the recently concluded DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Medical Spur stent system for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI), demonstrated that following predilatation, the Spur stent system achieved a 99.2% technical success rate and 97% freedom from major adverse limb events (MALE) and perioperative death at 30 days.
“Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur stent system,” said Mahmood K Razavi (St. Joseph Heart and Vascular Center, Orange, USA). “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,” he added.
S. Jay Mathews (Bradenton Cardiology/Manatee Memorial Hospital, Bradenton, USA) commented: “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. 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 [percutaneous transluminal angioplasty] alone can deliver.”
Both Mathews and Razavi were lead principal investigators for the study, which was conducted at 49 centres in the USA and enrolled 130 patients.
“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 optimise the treatment of BTK peripheral arterial disease,” said Teo Jimenez, senior vice president of R&D at Reflow Medical.
According to Reflow Medical chief executive officer and co-founder, Isa Rizk, “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.”
