Analysis
Endomagnetics Achieves CE Approval for Sienna+ Tracer
Endomagnetics has achieved CE approval for the sale of its magnetic tracer material, branded Sienna+. The injectable tracer is used in combination with the ultra-sensitive SentiMag instrument in sentinel lymph node biopsy (SLNB), currently the standard of care in tracking the spread of breast cancer.
The Endomagnetics’ development of the SentiMag and Sienna+ system allows best practice SLNB to be performed anywhere, by any practitioner, without substantially changing their working practice. The combined system offers reduced workflow complexity with a corresponding reduction in procedural cost.
“Achievement of CE approval for Sienna+ is an important milestone for Endomagnetics and our ability to deliver a complete solution to the market,” says Dr Eric Mayes, CEO of Endomagnetics. “It demonstrates that the system has met rigorous EU safety, health and environmental requirements.”
Endomagnetics recently showed its technology at the San Antonio Breast Cancer Symposium and received an enthusiastic reception from oncologists and surgeons from many countries.