PEDRA Technology

Info

Contact Whye-Kei Lye
Title Chief Operations Advisor

Description

Pedra Technology has developed the world’s first intra-operative monitor for real-time blood perfusion assessment which addresses a critical need in the peripheral vascular disease (PVD) market. PVD affects over 20 million people in the US, over 80 million people in China, and represents a multi-billion dollar opportunity. Without proper care PVD can lead to limb ischemia and amputations.
Chronic wounds or ulcers on the feet (unable to heal after 8 weeks due to poor blood flow) are treated with balloon angioplasty to re-open blocked blood vessels in the legs. During such procedures, the Pedra device gives the physician intra-operative instantaneous feedback on blood perfusion of foot tissue. It is this blood perfusion at the tissue level that is critical for wound healing. This is the first time that physicians, using the Pedra device, are able to achieve an accurate objective and quantitative measure of blood perfusion while the patient is still in the operating theater. No other technology does this, as X-ray angiograms only image macrovascular blood flow, which can lead to misleading conclusions, resulting in adverse outcomes or repeat procedures.
By using Pedra, the physician receives the full blood perfusion information to get the procedure done right the first time – saving limbs and reducing amputation rates. The Pedra system will provide clinicians with quantitative readouts of microcirculatory perfusion, allowing on-table assessment of procedural success to improve clinical outcomes, guiding utilization of advanced intervention devices, and facilitating optimal allocation of health care resources.

Company News

PEDRA™ Technology Receives FDA Breakthrough Device Designation for its PEDRA™ Xauron™ Real-Time Tissue Perfusion System

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DateJan 25, 2021
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).
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