New Surgical System Offers Alternative to Lumpectomy Wire Localization

The SAVI SCOUT^® surgical guidance system offers a strong alternative to wire localization for women who undergo a lumpectomy, according to a recent presentation at the American Society of Breast Surgeons Annual Meeting.¹

Pat Whitworth, MD, of the Nashville Breast Center in Tennessee, presented data from an investigator-initiated 154-patient trial that indicated SAVI SCOUT achieved a 100% surgical success rate and offered high clinical reproducibility. Ninety-seven percent of patients surveyed after the procedure would recommend it to other patients.

“These data reinforce earlier findings confirming that real-time surgical guidance with SCOUT is an extremely accurate technique for directing the removal of non-palpable breast lesions,” Dr Whitworth, a study investigator, said in a news release. “Furthermore, we now have strong evidence that the use of SCOUT is reproducible in multiple real-world clinical settings and is associated with high patient and physician satisfaction.”

More than 50 surgical sites in the United States use the tool, which the U.S. Food and Drug Administration cleared in late 2014, to pinpoint and direct the removal of non-palpable breast lesions. Its manufacturer, Cianna Medical Inc., describes the surgical guidance system as using electromagnetic waves to find a reflector a surgeon places in a tumor before surgery. The system aims to make lumpectomies more efficient and easier to plan, and to minimize their cosmetic effects.

The SCOUT handpiece sends out infrared light and a micro-impulse signals to locate the target tissue less invasively than traditional wire-localization or needle-localization, offering real-time audible and visual indicators during the procedure. “I find precision increases as the dissection proceeds, with immediate real-time feedback on target location, adding to confident retrieval of the targeted tissue volume,” Dr Whitworth said.

The study on the SCOUT system found no reflector migration among finished procedures with complete data. It also found high satisfaction among patients and clinicians. On a 1 to 5 scale, with 5 being most favorable and 3 being equal to wire localization, surgeons favorably rated their ability to start cases earlier (4.9) and to reduce operating room scheduling delays (4.3). Radiologists gave favorable ratings on the same scale to SCOUT’s patient comfort (3.7), patient anxiety (3.8), and overall patient experience (4.1).

Seventeen surgeons and 24 radiologists from 11 sites contributed to the study. The sites included the University of South Florida Breast Health, Nashville Breast Center, Baylor Regional Medical at Plano, Cancer Centers of Colorado, Hackensack University Medical Center, UC Irvine Health Pacific Breast Care Center, Medical Center of Plano Complete Breast Care, Morton Plant Mease Hospital, New York University Langone Medical Center, Pink Lotus Breast Center, and Texas Breast Specialists.

Annually, about 174,000 women undergo breast conservation surgery, with nearly one-third requiring repeat surgeries to remove all cancerous cells. The 100% success rate shown in the trial, Dr Whitworth said, offers promise for better overall outcomes for patients than wire localization, the present standard of care. “I expect clinical adoption of the system to continue to accelerate as patients and their doctors learn about this advance in care,” he concluded.

Reference

1. New Clinical Data Further Validate Cianna Medical’s SAVI SCOUT Breast Localization and Surgical Guidance System and Accelerate Clinical Adoption [news release]. Aliso Viejo, CA: Cianna MEdical; April 28, 2016. http://www.ciannamedical.com/press-releases/new-clinical-data-validate-cianna-medicals-savi-scout-breast-localization-surgical-guidance-system-accelerate-clinical-adoption/. Accessed May 9, 2016.