Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system.
Scout MD broadens the South Jordan, Utah–based company’s oncology portfolio. Merit designed the system to enhance the diagnosis and treatment of breast cancer, as well as other soft tissue cancers. The system includes the Scout radar localization system with Scout mini reflector and Scout Bx delivery system. It also features the Savi brachy system.
According to a news release, Scout MD supports the implantation of up to four different reflector configurations. When implanted within abnormal breast or other soft tissue, reflectors pinpoint tumor location in multiple dimensions. This enables more precise excision.
With a targeted approach, the system can help minimize damage to surrounding healthy tissue and decrease the likelihood of re-excision. Merit says it also helps to avoid the emotional and physical trauma associated with undergoing a second surgery. Dr. John Vincent Kiluk, a breast surgical oncologist at the Moffitt Cancer Center, said Scout MD “should improve a surgeon’s ability to obtain adequate margins on larger tumors and decrease the need for repeat surgery.”
The company said the regulatory nod for Scout MD coincides with a major company milestone. As of last month, Merit has distributed more than 500,000 devices for placement in breast surgery procedures worldwide.
“This momentum has enabled us to collect valuable real-world evidence through physician feedback, giving us a better understanding of what’s needed to improve oncology care,” said Fred P. Lampropoulos, Merit chair and CEO. “In turn, we’re developing new technologies, like SCOUT MD, that enhance the patient experience and reduce the burden breast cancer places on women worldwide. We’re honored to be a part of their care journey, and we intend to continue innovating for them.”
