Peripheral artery disease (PAD) results in decreased oxygen levels in a patient’s limbs, especially the lower legs. This can result in impaired ability to walk, infection, and in too many case, amputation. If detected early enough, treatment can help halt or even reverse the damage. This has the potential of saving more than $74 billion in healthcare costs each year in the U.S. alone.

Profusa, Inc. has developed an implant that measures oxygen levels not in the blood stream, but right in the tissue where the oxygen and nutrients are needed. We have covered the Lumee system before; it relies on tiny sensors that are injected in the patient’s body. A 3D scaffold of “smart gel” emits light when in the presence of oxygen (or other biomarkers). No power is required; the material fluoresces when it receives light from an outside source. A light with sensors held against the skin can take a non-invasive measurement by sensing the amount of light being emitted. One of the keys to the systems success is that the biosensor is designed to avoid triggering the natural foreign body defenses of the body. Sensors have been used successfully for two years without causing inflammation or rejection.

The news is that the Lumee system has received CE approval, allowing the company to market and sell the product in Europe. This gives physicians there a new tool to help combat PAD by identifying problems before symptoms even become apparent.