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January 25, 2021
Pedra Technology’s Xauron Tissue Perfusion System Receives FDA Breakthrough Device Designation
January 25, 2021—Pedra Technology announced that the FDA has granted the company a Breakthrough Device designation for the periprocedural use of its Xauron perfusion system in patients treated for chronic limb-threatening ischemia.
Vascular surgeon Paul Hayes, MD, who serves as Chief Medical Officer of Pedra Technology, commented in the announcement, “With the Xauron device, physicians can at last see real-time perfusion changes during an interventional procedure in the angiographic suite. I’m excited about building on our early clinical data and demonstrating that Xauron will save patient lives and limbs.”
The company noted that the Breakthrough Devices program at the FDA aims to provide patients and providers with timely access to medical devices that provide for more effective treatment and diagnosis of severe diseases, including a prioritized review of market approval regulatory submissions. The Pedra Xauron perfusion system is not approved for sale in the United States, advised the company.
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