Reflow Medical, Inc., a pioneer in the development of medical devices for cardiovascular diseases, has achieved a major milestone by obtaining CE Mark certification for its innovative Bare Temporary Spur Stent System. This certification, granted to Class IIa medical devices under the European Union Medical Device Regulation (2017/745), allows the device to be used in treating de novo or restenotic lesions in the infrapopliteal arteries, in combination with a commercially available drug-coated balloon (DCB) to enhance drug absorption within the European Union.
Advancing Treatment for Cardiovascular Diseases
Reflow Medical’s Bare Temporary Spur Stent System is specifically designed to meet the needs of patients suffering from chronic limb-threatening ischemia (CLTI), a condition that significantly increases the risks of mortality, amputation, and a decline in quality of life. The device has demonstrated promising results in clinical studies, surpassing traditional treatment methods such as plain balloon angioplasty or the use of a DCB alone.
Delivering Improved Outcomes
The Bare Temporary Spur Stent System reduces the need for clinically driven target lesion revascularization (CD-TLR), promotes wound healing, minimizes recoil, and enhances vessel patency over the course of a year. It provides stent-like results without the requirement of a permanent implant, thanks to a process called Retrievable Stent Therapy (RST). This self-expanding stent features radial spikes that create channels in the vessel wall, enabling superior drug absorption before being recaptured and removed.
Advancing Healthcare with Innovative Technology
The CE Mark certification for the Bare Temporary Spur Stent System is a significant step forward for Reflow Medical, Inc., as it allows the company to market this groundbreaking technology in the EU and other countries that recognize this certification. Established in 2011, the company takes pride in designing and developing technologies that empower physicians to offer more effective treatment for cardiovascular diseases.
