Jan 10, 2020: U.S. Food and Drug Administration (FDA) announced Reflow Medical’s Temporary Spur Stent System, a novel retrievable stent technology proposed for the treatment of below-the-knee (BTK) peripheral artery disease, designated for the Breakthrough Devices.
The Breakthrough Devices Program is designed in order to give patients and health care providers timely access to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The program offers Reflow Medical the chance to interact with experts at the FDA throughout the premarket review phase, in order to help speed the development, assessment and review of the device.
The Temporary Spur Stent System is a novel combination device that consist of a patented retrievable stent system having a series of radially expandable spikes designed to create multiple pathways in order to deliver antiproliferative drugs for increased uptake into the vessel wall and facilitate acute luminal gain, without leaving anything behind.
The device was developed in response to unmet clinical needs resulting in the high rates of restenosis and treatment challenges in patients with BTK disease. https://fda.einnews.com/article/506936937?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D
