Reflow Medical’s Spur® Peripheral Retrievable Stent System represents a significant innovation in endovascular treatment, especially for patients with chronic limb-threatening ischemia (CLTI) below the knee (BTK). This FDA De Novo-cleared device is the first retrievable stent system designed with integrated radial spikes and a balloon catheter for lesion penetration and modification. Unlike conventional permanent implants, Spur’s Retrievable Scaffold Therapy (RST) enhances acute luminal gain while modifying vessel compliance without leaving behind a permanent metallic scaffold. This novel approach provides a transformative solution to the complex problem of restenotic and de novo lesions in infrapopliteal arteries.

Clinically, the Spur Stent System has demonstrated strong performance and safety through the DEEPER REVEAL trial, with 99.2% technical success and 97.0% freedom from major adverse limb events (MALE) and perioperative death (POD) at 30 days. This performance suggests a substantial advancement over traditional balloon angioplasty alone. The device is particularly effective when used after predilatation to maximize luminal expansion and reduce the risk of recoil. Its retrievable nature adds flexibility for physicians, ensuring more controlled treatment outcomes in high-risk BTK cases often associated with diabetes and severe peripheral artery disease.

The FDA clearance marks a critical milestone in advancing care for CLTI patients, a population with limited treatment options and a high risk of limb loss. By offering an alternative to permanent stents, the Spur Stent System allows interventionalists to treat complex lesions with a more tailored, less invasive solution. Its approval is not only a testament to the success of rigorous clinical research but also a promising step toward improving patient outcomes in one of vascular medicine’s most challenging areas.

MedTech Spectrum's Summary

First-of-Its-Kind Technology: The Spur® Peripheral Retrievable Stent System is the first retrievable stent with integrated spikes and balloon dilation, offering a groundbreaking mechanical approach to treating complex BTK (below-the-knee) arterial disease without leaving behind a permanent implant.

Strong Clinical Results: In the DEEPER REVEAL trial, the device showed a 99.2% technical success rate and 97.0% freedom from major adverse limb events (MALE) and perioperative death (POD) at 30 days, underscoring its safety and effectiveness for CLTI patients.

Critical Advancement in Vascular Care: The FDA's De Novo clearance marks a significant step in expanding treatment options for chronic limb-threatening ischemia, offering physicians a novel, targeted tool to improve outcomes and reduce the risk of limb loss in a high-risk patient population.