August
2016
ISSUE
8

Additional FDA Clearance for SAVI SCOUT Radar Localization System

Extended flexibility for reflector placement supports improved patient and hospital scheduling
SCOUT® has received an additional FDA 510(k) clearance allowing the reflector to be placed at the lumpectomy site up to 30 days prior to surgical removal.
“The new clearance enabling reflector placement up to 30 days before surgery provides us even more flexibility with scheduling,” said Charles Cox, MD. “As an early adopter and ongoing user of SCOUT, I’ve found the technology to be highly intuitive, easy to implement and a significant improvement over wire localization in terms of patient experience. Importantly, use of SCOUT also supports greater efficiency in the hospital with less wait time for both patients and physicians.”
SCOUT is the first medical device to use radar in human tissue.
In seeking a more compassionate and precise approach to breast tumor localization, Cianna Medical developed micro impulse radar for use in tissue.  SCOUT radar localization is a h
ighly sophisticated technology capable of delivering unparalleled performance.

 

SCOUT Continues to Score High in Patient and Physician Satisfaction

The Northwell Health Cancer Institute implemented SCOUT in July. The following excerpts are  from an article that appeared in  the July 12 issue of Innovate Long Island.
“Breast cancer surgery or biopsy can be physically and emotionally distressing for women,” said Dr. Karen Kostroff, chief of breast surgery at Northwell.  “The SCOUT resolves one of the most difficult aspects of breast conservation surgery by eliminating the need to place a wire inside the breast tissue to locate a tumor.”
Ellen Gallin-Procida, a patient of Dr. Kostroff’s for the last 20 years, underwent three breast-conserving surgeries using the wire localization technique. She was one of the first patients at Northwell’s Cancer Institute to experience the wire-free, radar system during a breast biopsy.
 “You’re already under stress and frightened getting a breast biopsy,” Gallin-Procida said. “It’s uncomfortable to sit for a long time with a wire sticking out of your breast even though it’s covered in gauze. For my recent biopsy, I was checked in for surgery with the reflector having already been inserted days earlier.
“This time I had a lot less anxiety and discomfort before surgery without a wire sticking out of me.”
Click here
Innovate Long Island
to read the full article.

 

Peer Reviewed Data Published in Annals of Surgical Oncology 

Peer-reviewed data on SCOUT recently published in the July issue of
Annals of Surgical Oncology
demonstrated
100 percent surgical success,
with significantly lower repeat surgery rates than those reported when using wire localization. In all cases where localization was performed, targeted lesions and reflectors were successfully removed without any observed reflector migration. In another key study finding, researchers concluded that the SCOUT reflector could be reliably detected up to 5 cm from the handpiece.
The study also demonstrated high clinician and patient satisfaction with SCOUT. Overall, physicians reported favorably on patient comfort, patient anxiety and overall patient experience and a majority of physicians (85%) reported workflow improvement with SCOUT compared with wire localization.
O
n a scale of 1-5, where 3 was equal to wire localization, surgeons favorably rated ability to start cases earlier at 4.9, 4.4 for patient wait times and 4.4 for reduction in OR scheduling delays.
Radiologists and surgeons also reported a 4.1 for a better overall patient experience.
Post-procedure survey data indicated that 97% of patients would recommend SCOUT to others.

 

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.