Reflow Medical’s Bare Temporary Spur Stent System Nabs CE Mark

Reflow Medical, a cardiovascular disease-focused medical device company, today announced it has received a CE Mark for the Bare Temporary Spur Stent System to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coasted balloon (DCB) to enhance drug absorption.

The stent system is intended to provide stent-like results without leaving metal behind. Used as part of Retrievable Stent Therapy, the stent, which is self-expanding and designed with radial spikes, creates channels in the vessel wall to enhance drug absorption and reduce coil. The device is then recaptured, removed, and treated with a commercially available DCB.

The device, followed by DCB treatment, according to the company, reduces “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.”

Granted certification as a Class IIa medical device under the European Union Medical Device Regulation, the company said its next goal is to market and commercialize the stent.

“Earning the CE Mark is a huge milestone for the company,” said Isa Rizk, co-founder and CEO of Reflow Medical. “It enables us to offer a clinically validated solution to an unmet need in a major disease area. Our next goal is to expand our organization to commercialize this breakthrough technology and serve the needs of physicians and their patients in countries accepting this certification.”