The US Food and Drug Administration (FDA) has granted 510(k) clearance to Cianna Medical to expand the indication of its SAVI SCOUT reflector for use in localization of soft tissue, including lymph nodes.
SCOUT is claimed to be the only wire-free breast localization system that uses radar to mark a lumpectomy or biopsy site, with no significant artifacts on magnetic resonance imaging (MRI) studies.
It is non-radioactive and non-magnetic, making it easy to use and offering better precision and accuracy.
Since 2016, the SCOUT system has been used for wire-free breast tumor localisation and has proven in over 42,000 procedures across 325 medical centers in the US.
The medical device company claimed that SCOUT is suited for marking tumors, biopsy sites and lymph nodes before the neoadjuvant therapy takes place.
As SCOUT reflector does not have clinically significant MRI artifact, it does not interfere with MRI studies and there is no restriction on the imaging modalities that can be effectively used throughout a patient’s treatment.
SCOUT has also been shown to improve radiology work flow and significantly reduce OR delays.
Cianna Medical president and CEO Jill Anderson stated that radiologists and surgeons have expressed a clinical need for wire-free lymph node localization and targeted axillary node dissection.
“This expanded FDA clearance gives physicians even greater flexibility for planning individualized breast cancer treatment and offers more patients a better experience,” Anderson said.
The expanded FDA clearance gives physicians a greater flexibility to plan individualized breast cancer treatment and offers a chance for better experience for more patients.
Cianna Medical has been in the development and commercialization of the first non-radioactive, non-magnetic wire-free breast localization system and the only technology to use radar in tissue.
Last month, the Lehigh Valley Cancer Institute, a part of Lehigh Valley Health Network (LVHN), adopted the SCOUT Wire-Free Radar Breast Localization System to provide easier, more compassionate care to women undergoing treatment for breast cancer.
Cianna’s SCOUT and SAVI Brachy technologies are FDA-cleared and address unmet requirements in the delivery of radiation therapy, tumor localization and surgical guidance.