Reflow Medical's Bare Temporary Spur Stent System receives CE Mark for treating below-the-knee (BTK) lesions
Tuesday, January 16, 2024
Reflow Medical, a company specializing in innovative cardiovascular medical devices, has recently obtained CE Mark certification for its Bare Temporary Spur Stent System in the European Union. This system is designed to address de novo or restenotic lesions in the infrapopliteal arteries by utilizing a commercially available drug-coated balloon (DCB) for improved drug absorption.
Noteworthy clinical studies on patients with Critical Limb Threatening Ischemia (CLTI) demonstrate favorable results, including a reduction in clinically driven target lesion revascularization (CD-TLR), enhanced wound healing, decreased recoil, and improved vessel patency for up to one year.
The unique Bare Temporary Spur Stent System, part of the Retrievable Stent Therapy (RST), delivers stent-like outcomes without leaving any metallic residue. It has received certification as a Class IIa medical device under the stringent European Union Medical Device Regulation (2017/745), requiring comprehensive evidence of its performance and safety.