Perfusion system for CLI nets breakthrough device designation
Pedra Technology announced the FDA granted breakthrough device designation for periprocedural use of its perfusion system for the treatment of critical limb ischemia.
“With the Xauron device, physicians can at last see real-time perfusion changes during an interventional procedure in the angiographic suite,” Paul Hayes, MD, vascular surgeon and chief medical officer of Pedra Technology, said in a press release. “I’m excited about building on our early clinical data and demonstrating that Xauron will save patient lives and limbs.”
Under the Breakthrough Devices Program, the FDA will prioritize the review of the technology after an application for approval is filed.
“This breakthrough device designation recognizes the compelling need for real-time tissue perfusion monitoring during lower limb revascularization procedures for the treatment of critical limb-threatening ischemia (CLTI). To my knowledge, this is the first perfusion monitor for CLTI that has received this designation,” Kareen Looi, CEO of Pedra Technology, said in the release. “An improvement in microvascular perfusion at the tissue level is necessary for elimination of rest pain, healing of chronic wounds and for limb salvage. We look forward to developing this important new technology and working closely with the FDA to develop the appropriate clinical program for market approval.”
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