Reflow Medical’s retrievable stent technology, Temporary Spur Stent System, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).
The technology, intended for the treatment of below-the-knee (BTK) peripheral artery disease, consists of a retrievable stent system having a series of radially expandable spikes designed to create multiple pathways 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 high rates of restenosis and treatment challenges in patients with BTK disease.
Isa Rizk, CEO of Reflow Medical, said: “We are extremely grateful to the FDA for their expedited designation of the Temporary Spur Stent System as a Breakthrough Device. We plan to take full advantage of the Program’s benefits, accelerating our efforts towards meeting the requirements of the review process as we advance this novel technology, with the goal of improving the lives of patients.”
