Cianna Medical, Inc. announced the presentation of clinical results showing that SAVI SCOUT, its breast localization and surgical guidance system, has a perfect success rate, high clinical reproducibility, and favorable levels of clinician and patient satisfaction. The presentation was given by Dr. Pat Whitworth, a breast surgeon and study investigator, at the 17th Annual Meeting of American Society of Breast Surgeon (ASBrS) held April 13–17 in Dallas, Texas.
SAVI SCOUT is an U.S. Food and Drug Administration (FDA)-approved guidance system for the removal of non-palpable breast lesions. It uses non-radioactive, electromagnetic wave technology to detect a reflector placed in the target tissue up to seven days prior to surgery.
Results from a pilot study, evaluating the placement, localization, and retrieval of targeted lesions and reflectors in 154 patients, showed a 100 percent surgical success rate, as well as lower rates of repeat surgery compared to the use of wire localization. In all clinical cases, targeted lesions and reflectors were effectively removed without any reflector migration.
High clinician and patient satisfaction were also reported. On a 1-5 scale, with 3 being equivalent to wire localization, surgeons positively rated the system for an ability to begin cases earlier at 4.9, and at 4.3 for a reduction in surgical scheduling delays. Likewise, radiologists rated patient comfort, anxiety, and overall experience higher than wire localization, at 3.7, 3.8, and 4.1, respectively. Results from a post-procedure survey also found that 97 percent of patients would recommend the system to others.
SAVI SCOUT consists of an electromagnetic wave reflective device (reflector), handpiece, and console, and uses real-time audible and visual indicators to allow surgeons to more easily locate the micro-reflector and the tissue targeted for removal in a lumpectomy or excisional biopsy. It is now in use at more than 50 medical centers across the U.S., the company reported in a press release.
“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 surgeon with the Nashville Breast Center in Tennessee, said in the 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.”
Rochelle Colon, a patient who has undergone two separate lumpectomy procedures, added, “When I was first diagnosed with breast cancer, my doctor used wire localization. This time around, 15 years later, SAVI SCOUT was used for the localization procedure. The tumor was much smaller, and so it was not easy to find. … With SCOUT, my doctor was able to pinpoint the tumor immediately.”
The study was undertaken across at 11 clinical settings, involving a group of 17 surgeons and 24 radiologists. Participating centers included: Nashville Breast Center, University of South Florida Breast Health, Medical Center of Plano (Texas) Complete Breast Care, Hackensack (New Jersey) University Medical Center, Cancer Centers of Colorado, University of California Irvine Health Pacific Breast Care Center, New York University Langone Medical Center, Morton Plant Mease Hospital (Florida), and Texas Breast Specialists.
“These promising results underscore why we chose micro-impulse radar as the platform technology for tumor localization,” said Jill Anderson, president and CEO of Cianna Medical. “SCOUT is a zero radiation and wire-free solution that has demonstrated the potential to drive value by reducing costs and improving patient outcomes.”
The device was approved for use by the FDA in 2014.
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