FDA clears world’s first and only, non-radioactive, wire free breast tumor localizer for extended use

Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term use.

The SAVI SCOUT reflector is an integral part of the SAVI SCOUT® surgical guidance system, a novel wire free technology that uses real-time audible and visual indicators for precise localization of tumor during lumpectomy and excisional biopsy procedures.

This technology is the first and only non-radioactive implant, that uses electromagnetic wave technology, with no restrictions on the length of time the reflector can remain in the breast. 

This will enable the surgeons to precisely target the affected tissue using the system’s capability of 360˚ detection and ability to pinpoint tumor location down to ±1mm, this conserves breast tissue and is more aesthetic for women at the same time increasing the surgical precision and reducing the need for repeat surgery.  

In addition, a woman with in situ SCOUT reflector can easily undergo MRI, as it does not interfere with the study.

The SCOUT reflector is 4 mm in size, and remains completely passive till it is activated by a handheld radar system. As the radar system is placed against breast, the Scout system starts sending audio-visual cues for the precise position of the reflector.  

It also eliminates the need of same day surgery and can remain in place between the time of biopsy to surgery.

Before the clearance the reflector was only allowed to stay in place for 30 days, now the time limit has been removed.

The device received its initial clearance in 2014, based on a result of small pilot study of 50 patients published later in June 2016 in the Annals of Surgical Oncology.

A larger subsequent study also by Cox et al. was published in Annals of Surgical Oncology involved 154 patients and the researchers concluded that, “SCOUT provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.”

Dr. Alice Police was the first surgeon in the country to adopt SCOUT in late 2015, at UC Irvine Medical Center, in Orange County, CA.   “My focus is always on finding a better breast cancer operation,” Dr. Police said.   “SCOUT is the standard of care for my breast localizations as I utilize this wire-free approach for all scenarios requiring localization.  The distance feature provides more control over the procedure which is important for predictable outcomes.”

Cianna Medical requires that each site and physician using SCOUT Radar Localization successfully complete training prior to initial cases. 

SCOUT Real-Time Distance Animation from Cianna Medical Inc. on Vimeo.