Singapore-based Pedra Technology announced today that the FDA has granted the company breakthrough device designation for the periprocedural use of its 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.
According to Pedra, the non-invasive Xauron system offers:
- Real-time perfusion feedback in less than 10 seconds.
- Up to four channels to assess perfusion changes across foot angiosomes.
- Portability and VESA-compatibility for use with rolling cart or pole platforms.
- Radiolucent sensors that integrate seamlessly with angiographic imaging.
- A simple user interface for physicians and angio suite staff.
- A built-in battery that permits continuous monitoring from angio suite to recovery room.
“This breakthrough device designation recognizes the compelling need for real-time tissue perfusion monitoring during lower limb revascularization procedures for the treatment of CLTI,” said Pedra Technology CEO Kareen Looi in a news 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.”