FDA Clears Wire-Free Breast Tumor Locator for Long-term Use

Roxanne Nelson, BSN, RN

November 16, 2017

A wire-free, nonradioactive breast tumor localization device has been cleared for long-term use by the US Food and Drug Administration (FDA).

This device, the SAVI Scout reflector, is part of the SAVI Scout surgical guidance system (Cianna Medical Inc).

The system uses an intratumoral electromagnetic wave device, implanted under ultrasound or mammographic guidance, to localize occult breast lesions with a probe during surgery.

Last year, the reflector received clearance to be placed at the lumpectomy site for up to 30 days prior to surgical removal. Now, however, there is no limit on the period it can remain in place.

"The definition of 'long-term' from the FDA is 'permanent,' it does not have to be removed," said Jill Anderson, resident and CEO of Cianna Medical. "And it may never be removed, especially if it goes in at the time of biopsy," which lifts constraints from the physicians, she added.

According to the company, the reflector does not interfere with MRI studies and so patients are not restricted as to the types of imaging modalities they can undergo. The reflector measures 4 mm, is 100% nonradioactive, and is completely passive until activated by the Scout guide. Patients are unable to feel the reflector once it is in place, and it does not interfere with day-to-day activities regardless of how long it is left in the breast, the manufacturer noted in a press release.

Nina Vincoff, MD, chief of breast imaging at Northwell Health, Lake Success, New York, said in that press release: "Our patients have indicated high satisfaction with the procedure. This new FDA clearance will continue to enhance the patient experience by offering more options and flexibility for physicians to implant the reflector based on patient treatment needs."

May Reduce Reexcision

Wire localization, which has been used for decades, has some notable disadvantages, including patient discomfort and the potential for wire displacement. It is seriously limited by the need for same-day wire placement and excision, Anderson commented in an interview.

The SAVI Scout reflector eliminates the need for placement on the same day as surgery, and with the new FDA clearance, it can remain in place during the period between biopsy and surgery, she explained. "If a woman is undergoing neoadjuvant chemotherapy, there may be a considerable span of time from biopsy until surgery, and it also eliminates the need for a second localization procedure at the time of surgery."

Another problem that the company wanted to address was that "anywhere from 30% to 60% of women having a lumpectomy and who use a wire device may need to have a secondary surgery because not all of the cancer was removed," Anderson told Medscape Medical News. "The wire is one of the primary causes of incomplete surgery. There are data that show that using a better localizer brings resurgery down to single digits."

Data on the SAVI Scout system were initially presented in 2014 at the San Antonio Breast Cancer Symposium and were reported at that time by Medscape Medical News. The device had just received its initial clearance from the FDA at that time.

At that meeting, Charles Cox, MD, a surgeon from the University of South Florida College of Medicine, in Tampa, presented preliminary data on the SAVI Scout surgical guidance system.

He reported on 24 patients who underwent intratumoral placement of the electromagnetic reflector under ultrasound or mammography guidance. The reflector was placed an average of 1.1 days before surgery and was then localized in the operating room with the use of a hand piece and console to detect feedback.

Seven patients underwent excisional biopsy and 17 underwent lumpectomy; for all patients, the reflector and lesion were successfully removed.

Final pathology findings, which were available for 19 patients, were benign in all patients who underwent excisional biopsy. Clear margins were noted in 11 of 12 lumpectomy patients. One patient was found to have a positive margin and required reexcision.

"I would like to see this being used for any nonpalpable breast biopsy procedure," Dr Cox commented at the time.

The pilot study of the device, which eventually enrolled 50 patients, was subsequently published in June 2016 the Annals of Surgical Oncology.

In an editorial published in Annals of Surgical Oncology at the time the pilot trial was published, James W. Jakub, MD, Mayo Clinic, Rochester, Minnesota wrote that the SAVI Scout device has "the potential to provide an additional means of replacing wire-localized procedures."

A larger trial, involving 154 patients, that was also headed by Dr Cox, was published in the same journal in October 2016. This trial showed high surgical success with the locator and significantly lower rates of repeat surgeries than those reported with use of wire localization.

The reflectors were placed in 153 of 154 patients (one patient required a wire); all 154 lesions and reflectors were successfully removed during surgery. Of the 101 patients who had received a preoperative cancer diagnosis, 86 (85.1%) were found to have clear margins; 17 (16.8%) patients required margin reexcision.

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