Reflow Medical announced yesterday that its Temporary Spur Stent system for treating below-the-knee peripheral artery disease (PAD) won FDA breakthrough device designation.
The Temporary Spur Stent system includes radially expandable spikes designed to create multiple pathways for delivering antiproliferative drugs for increased uptake into the vessel wall for facilitating acute luminal gain without leaving anything behind.
Reflow developed the device in response to unmet clinical needs that resulted in high rates of restenosis and treatment challenges for patients with below-the-knee PAD, according to a news release.
The San Clemente, Calif.-based company said it plans to build on clinical evidence supporting the Temporary Spur Stent system and continue development in other clinical areas based around the Spur platform.
“We are extremely grateful to the FDA for their expedited designation of the Temporary Spur Stent system as a breakthrough device,” Reflow Medical CEO Isa Rizk said in the news release. “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.”