Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System

Reflow Medical has received CE Mark certification in the European Union for the Bare Temporary Spur Stent System for the treatment of de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.

The Bare Temporary Spur Stent System, followed by drug-coated balloon treatment, reduces clinically driven target lesion revascularization (CD-TLR), improves wound healing, reduces recoil, and improves vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone.

The Bare Temporary Spur Stent System is a unique clinical solution designed to deliver stent-like results without leaving metal behind. Known as Retrievable Stent Therapy (RST), the self-expanding stent is designed with radial spikes to create channels in the vessel wall to enhance drug uptake and reduce recoil. The stent is then retrieved, removed and treated with a commercially available drug-coated balloon.

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