Reflow Medical announced that its Temporary Spur stent system—novel retrievable stent technology intended for the treatment of below-the-knee peripheral arterial disease—has been designated for the Breakthrough Devices Program by FDA. The Temporary Spur stent system is a novel combination device that consists of consisting of a retrievable stent system.
The system has 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 below-the-knee disease.
Isa Rizk, CEO of Reflow Medical, comments: “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.”