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.