PEDRA™ Technology, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its PEDRA™ Xauron™ Perfusion System in the treatment of critical limb threatening ischemia (CLTI).
CLTI is a severe form of peripheral artery disease (PAD) that is defined as ischemic rest pain, tissue loss, or gangrene (tissue death) that develops as a result of chronically poor blood flow to the lower limbs. If left untreated, CLTI can lead to limb amputation or death. The 1-year mortality rate of CLTI patients without amputation is 30.3% and with amputation is 40.4%. At 5-years post-CLTI diagnosis, the mortality rate exceeds 50%, which is worse than most cancers.
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.
“This Breakthrough Device Designation recognizes the compelling need for real-time tissue perfusion monitoring during lower limb revascularization procedures for the treatment of CLTI. To my knowledge, this is the first perfusion monitor for CLTI that has received this designation,” said Kareen Looi, CEO of PEDRA Technology. “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.”
Paul Hayes, MD, vascular surgeon and CMO of PEDRA Technology, commented, “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.”