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January 9, 2020
Reflow Medical’s Temporary Spur Stent System Granted FDA Breakthrough Device Designation
January 9, 2020—Reflow Medical, Inc. announced that the company’s Temporary Spur stent system has been designated for the FDA Breakthrough Devices program. The device is intended for the treatment of below-the-knee peripheral artery disease.
According to Reflow Medical, the Temporary Spur stent system is a combination device consisting of a retrievable stent system that features 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 Temporary Spur stent system is an investigational device only and is not currently approved for sale, advised the company.
The FDA’s Breakthrough Devices program is designed 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 opportunity to interact with experts at the FDA throughout the premarket review phase to help speed the development, assessment, and review of the device.
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