The findings of an investigator-initiated trial have determined that the SAVI SCOUT® surgical guidance system, developed by Cianna Medical, Inc. (CA, USA), is safe and effective when used for the localization of nonpalpable breast lesions. The study, which was recently presented at the 32nd Annual Miami Breast Cancer Conference® (26 February–1 March 2015, FL, USA), reports a 100% surgical success rate for removal of targeted lesions with the SAVI SCOUT system.
The standard procedure for localizing nonpalpable breast tumors during breast-conserving therapy is wire localization, in which a wire is utilized to direct the surgeon to the breast tumor. Current statistics indicate that approximately 30% of the 174,000 women who undergo these procedures every year will require further surgery due to incomplete tumor removal.
The SAVI SCOUT guidance system is a US FDA-cleared tool that harnesses real-time audio and visual indictors to allow precise targeting of tissue during lumpectomy and excisional biopsy procedures. The system utilizes passive nonradioactive electromagnetic wave technology to provide this guidance via a reflector, which is placed in the target tissue up to 7 days prior to surgical treatment.
The study, led by Charles E Cox of the University of Florida College of Medicine (FL, USA), involved 49 breast cancer patients, both in Florida (n = 22) and at the Nashville Breast Centre (TN, USA; n = 27). These patients all received surgery with the SAVI SCOUT system – nine underwent excisional biopsy and 40 had a lumpectomy.
In all cases, targeted lesions and reflectors were successfully removed, and the primary results suggest a 100% success rate of SAVI SCOUT. Final pathology results demonstrated that 93% of the individuals who underwent lumpectomy with SAVI SCOUT had clear margins. Additionally, eight of the nine patients who underwent excisional biopsy had no identifiable invasive or in situ carcinoma.
“The SAVI SCOUT surgical guidance system confers several advantages over the current medical standards to identify nonpalpable breast lesions. In addition to the uncomfortable wait times that patients have traditionally faced between the localization procedure and the surgery, standard techniques often don’t allow us to spare as much healthy tissue as we might want,” commented Cox. “Additionally, using SAVI SCOUT eliminates the need for invasive wires to be implanted into the breast, a procedure which has been shown to increase patient anxiety and discomfort.”