Scout Marks the Spot in Soft Tissue for Cancer Treatment

Cianna Medical celebrated another regulatory milestone this week after FDA cleared its Scout reflector for an extended indication, allowing the tiny device to be used to mark soft tissue sites, including lymph nodes.  The non-radioactive wire-free localization device is smaller than a grain of rice (4mm) and won the gold award in the 2017 Medical Device Excellence Awards for the category of ER and OR tools, equipment, and supplies. Last year FDA cleared the device for implantation in breast cancer patients without restrictions on the length of time that it can remain in the breast. The reflector is completely passive until activated by a handpiece, which acts as the radar system, at the time of the procedure to locate the reflector. "The first FDA clearance for Scout was really about using it to target and remove breast tissue, so that would essentially be the tumor and the area surrounding the tumor," Jill Anderson, president and CEO of Cianna Medical, told MD+DI. "When we take care of women who have a diagnosis of breast cancer, sometimes they have a suspicious lymph node ... this indication expansion allows the physicians to use this to remove those lymph nodes." It also means that if the physician chooses to biopsy the node first, before removing it, they can leave the Scout reflector behind in a single procedure. Then, if they later decide the node needs to be removed, the patient doesn't have to go through a second localizing procedure because the reflector ...
Source: MDDI - Category: Medical Devices Authors: Tags: Imaging Implants Source Type: news