June
2015
ISSUE
No. 2

SAVI SCOUT® White Paper Published by Oncology Central

The SAVI SCOUT white paper, entitled Beyond Wires: Overcoming the Challenges of Breast Tumor Localization, discusses the common challenges physicians experience with current localization techniques, including scheduling inefficiencies, surgical planning and guidance limitations, high re-excision rates and sub-optimal patient experiences. The good news? The SAVI SCOUT surgical guidance system addresses these challenges, while providing a technology that is non-radioactive.

The paper also includes in-depth interviews with Dr. Charles E. Cox of USF Breast Health and Dr. Pat Whitworth of Nashville Breast Center, the first surgeons to utilize SCOUT® technology in the Pilot Study, and concludes with a case study of a 60-year-old woman whose tumor was successfully removed with SCOUT.

If you would like to receive a hard copy of this piece, please contact info@ciannamedical.com. To view online, simply click on the Oncology Central logo below.

Product Availability and Evaluation Update

The SAVI SCOUT Clinical Evaluation Study is currently enrolling and will accrue up to 150 patients. This trial is expected to be completed in the next few months. Since SCOUT is already FDA cleared, select geographic areas are targeted to receive the commercial product this summer. SCOUT will be available nationwide beginning Fall 2015.

In the clinical trial results, physicians are reporting SCOUT to be a very intuitive technology. Dr. Cox, Principal Investigator of the Clinical Evaluation Study and the completed Pilot Study, reported the following excerpt in Surgical Products (May 2015):

What kinds of training did the surgeons and radiologists receive before/while this study was conducted? Would this be the same for surgeons and radiologists not participating in the study?

“We’ve observed that clinicians are able to quickly learn how to use SAVI SCOUT and rapidly gain proficiency in breast tumor localization using the system. On average, it takes approximately two cases for most individuals to become comfortable and proficient with the procedure. 

 

We would expect a similar learning curve for surgeons and radiologists not participating in the study. For surgeons, it’s a matter of mastering the deliberate movement of the handpiece and applying the correct amount of pressure. For radiologists, it’s simply adopting a slightly different technique when using the reflector delivery system.”

 

Product Evaluation

To accommodate the lead time necessary for evaluation and/or purchase approval of new technology, Cianna Medical is inviting interested sites to begin the process of setting up a 3 case evaluation.  If interested please complete this short survey.

Excitement Building in the Medical Community

On December 10, 2014 at the San Antonio Breast Cancer Symposium, Cianna Medical announced FDA clearance for the SAVI SCOUT surgical guidance system. Since then this exciting new technology has caught the attention of the medical community. Posters have been presented at the San Antonio Breast Cancer Conference, Miami Breast Cancer Conference, Society of Surgical Oncology Annual Cancer Symposium and American Society of Breast Surgeons Annual Meeting. There has also been a podium presentation at the National Consortium of Breast Cancer. To date over 20 news stories have been written about the novel technology, and its potential to significantly impact the future of breast cancer treatment.

President and CEO Jill Anderson sums it up, “Cianna Medical adheres to a patient-centric mission and the introduction of SCOUT is an important milestone in our ongoing commitment to deliver innovative products that improve patient outcomes and quality of life.  We look forward to bringing this new technology to the breast cancer community.”

How Does SCOUT Work?
SAVI SCOUT surgical guidance system uses non-radioactive, electromagnetic wave technology to provide real-time surgical guidance during breast surgery. The system consists of an electromagnetic wave reflective device (reflector), handpiece and console. The surgeon uses the handpiece to detect the location of the implanted reflector. The console provides real-time audible and visual indicators of the proximity of the reflector, giving surgeons a precise way to target tissue for removal.
SAVI SCOUT Surgical Guidance System

 

 

This e-newsletter is brought to you by Cianna  Medical, Inc., a women’s health company dedicated to the innovative treatment of early-stage breast cancer. As the only company dedicated exclusively to breast conservation therapy, Cianna’s commitment is to improve care and reduce the burden breast cancer treatment places on nearly 300,000 women and their loved ones each year.