Cianna Medical Inc. has received FDA approval for a surgical guidance system that uses real-time audible and visual indicators to help with tissue targeting during lumpectomy and excisional biopsy procedures. The product is called SAVI SCOUT and it may help reduce the number of repeat procedures required for breast cancer patients, while also improving the patient experience.
The system works by placing a detector in the target tissue up to seven days before the procedure, then during surgery the doctor uses a hand-piece to locate the detector and plan the incision. The detector makes it easier for the doctor to spare healthy tissue while removing the target, and is itself removed in the course of the procedure.
DOTmed News spoke to Dr. Pat Whitworth, breast surgical oncologist and director of the Nashville Breast Center, about how this new system improves upon the standard preoperative technique of inserting a guide wire into the breast.
According to Whitworth, the guide wires are not only highly unpleasant for the patient, but they can also be difficult to find at the time of treatment.”I am in a position now where I don’t want to do lumpectomies without real-time guidance,” said Whitworth. “I am confident I’m removing the right tissue and not the tissue I don’t need to.”
In terms of what it does, Whitworth compared the system to the metal detectors beach combers use to look for treasure in the sand, but said the SAVI SCOUT “was actually quite an engineering feat to create.”
Results from a SAVI SCOUT pilot study were presented last Wednesday at the San Antonio Breast Cancer Symposium. All 24 of the patients in the study were found to have successful placement, localization, and retrieval of the detector.
Whitworth said that using the new system in conjunction with pre and post-operative ultrasound is “dramatically complimentary,” and expects physicians to eagerly adopt this system if given the opportunity.