Cianna Medical received the 2016 Scientific Impact Award at this year’s American Society of Breast Surgeons (ASBrS) Annual Meeting for its presentation validating the clinical utility of its proprietary, FDA-cleared SAVI Scout breast localization and surgical guidance system.
The Scientific Impact Award is given to clinical research presentations that are considered to have the greatest scientific impact on breast cancer care, according to surgeon attendees’ criteria.
SAVI Scout, available since 2015, is a breast lesion localization tool that uses micro-impulse radar to localize and direct the removal of non-palpable breast lesions. The technology was quickly adopted by breast cancer physicians and is now available in more than 50 medical centers across the country.
“According to a recent market report, the number of breast localization procedures is expected to nearly double by 2020,” said Jill Anderson, Cianna’s president and CEO, in a press release. “We need advanced technologies like SCOUT that will help meet that growth by significantly reducing or eliminating the serious operational inefficiencies that exist with all current breast localization devices.”
The report, “Hospitals Have Spoken: How Medtech Can Benefit from the Affordable Care Act’s Focus on Outcomes,” is an independent research that found U.S. hospital executives have changed their opinion on cost containment and are now focusing their efforts on optimizing performance against quality metrics and driving operational efficiency.
Another study, “Breast Lesion Localization Methods Market – Comparative Analysis, Field Force Analysis, Business Models, End User Preference Survey (Selection Criteria, Qualitative Analysis of Replacement Trend), Competitive Product Portfolio and Strategic Consolidation,” has also reported that nearly 40 percent of all healthcare providers consider the possibility of shifting to more technologically advanced options for breast lesion localization that do not require invasive wires or radiation if shown to improve patient care.
The main objective in breast-conservation surgery is to remove all detectable cancer cells. It is estimated that of the 174,000 women who have to undergo breast conservation surgery each year, nearly 30 percent will need to repeat the procedure because cancer cells were not completely removed during the first procedure.
Nearly two decades ago, the wire localization (WL) preoperative technique became standard procedure for localizing non-palpable breast lesions. With WL, a wire is inserted into the breast by a radiologist to guide the surgeon to the target tissue. The most common challenges reported with WL include scheduling and workflow, surgical planning and guidance, high re-excision rates, and sub-optimal patient experience.
The SAVI Scout system is capable of detecting a reflector that is placed at the tumor site up to seven days before a lumpectomy or surgical biopsy. During this procedure, the surgeon scans the breast using the Scout handpiece, which works with infrared light and a micro-impulse signal to detect the location of the reflector.
Real-time, audible and visual indicators can then assist the surgeon in the accurate location of the reflector, along with the target tissue. This high level of precision enables a surgical approach that also results in better cosmetic outcomes.
“We have received favorable feedback from clinicians, patients and administrators indicating that SCOUT is helping to address unmet needs through improved workflow, simplified scheduling, and high quality clinical results across diverse healthcare delivery settings,” said Terry Hardin, Cianna Medical’s director of marketing and technology.
According to Nashville, Tennessee-based breast surgeon Pat Whitworth’s paper, presented at the ASBrS annual meeting and titled “A Prospective, SingleArm, Multi-Site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions During Excision,” the data included in the study showed that Scout achieved 100 percent surgical success, high clinical reproducibility and favorable satisfaction rates, by both physicians and patients. And, 97 percent of the patients in the study said they would recommend Scout to other women.
Whitworth is a breast surgical oncologist and director of the Nashville Breast Center. He accepted the award on behalf of his research team, including Tampa-based lead study investigator Charles Cox, M.D., and the remaining clinical study investigators. Cox is a professor of surgery and the McCann Foundation Endowed Professor of Breast Surgery at the University of South Florida College of Medicine and director of the University of South Florida Breast Health Program, as well as director of Morsani Ambulatory Surgery Center.
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