The US Food and Drug Administration (FDA) has granted Pedra Technology a breakthrough device designation for the periprocedural use of the company’s Pedra Xauron perfusion system in the treatment of critical limb-threatening ischaemia (CLTI).
CLTI is a severe form of peripheral arterial 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 one-year mortality rate of CLTI patients without amputation is 30.3%, and with amputation is 40.4%. At five-years post-CLTI diagnosis, the mortality rate exceeds 50%, which is worse than most cancers.
The breakthrough devices programme at the FDA aims to provide patients and providers with timely access to medical devices that offer for more effective treatment and diagnosis of severe diseases, including a prioritised review of market approval regulatory submissions.
Paul Hayes, vascular surgeon and CMO of Pedra Technology, comments: “With the Xauron device, physicians can at last see real-time perfusion changes during an interventional procedure in the angiographic suite. I am excited about building on our early clinical data and demonstrating that Xauron will save patient lives and limbs.”
Hayes spoke to this newspaper last year at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about the challenges of wound care, in particular assessing the success or failure of endovascular treatment of peripheral arterial disease. At the time, he described Pedra as a novel, portable, tissue-monitoring device that uses laser, and that provides real-time quantitative feedback in the angiosuite about whether the proceduralist has truly achieved improved blood flow to the microcirculation in the foot. Hayes noted that the device does not interfere with the workflow in the cath lab. The full interview can be seen here.“This breakthrough device designation recognises the compelling need for real-time tissue perfusion monitoring during lower limb revascularisation procedures for the treatment of CLTI. To my knowledge, this is the first perfusion monitor for CLTI that has received this designation,” comments 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 programme for market approval.”