Sign up for the QMED & MD+DI Daily newsletter.
Reflow Medical’s Bare Temporary Spur Stent System Nabs CE Mark
The system is designated to treat de novo or restenotic below-the-knee lesions.
January 16, 2024
1 Min Read
Image courtesy of Business Wire
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.”
About the Author(s)
Managing Editor, MD+DI
Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].
You May Also Like
Pedersen's POV graphic featuring the headshot of MD+DI Senior Editor Amanda Pedersen and a pull quote from the latest edition of her opinion column.
The EU AI Act: How Will It Impact Medical Device Manufacturers?Feb 27, 2024|8 Min Read
BioSig's Ridiculously Sparse Layoff Announcement Reeks of CallousnessFeb 26, 2024|3 Min Read
Sourcing Electrical Components: Are We Back to Normal?Feb 26, 2024|6 Min Read
Your Smartwatch Can’t Measure Blood Glucose Levels… YetFeb 26, 2024|3 Min Read