SCOUT MD? Receives FDA Breakthrough Device Designation | March 2023
Merit Medical Oncology
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Merit Medical Receives FDA Breakthrough Device Designation for the New SCOUT MD? Surgical Guidance System
The SCOUT MD is the latest in Merit’s ongoing commitment and leadership in advancing oncology care. SCOUT MD expands Merit’s portfolio of products to optimize oncology for breast and other soft tissue cancers, which includes the SCOUT Radar Localization system with new SCOUT Mini Reflector and SCOUT Bx? Delivery System, and the SAVI? Brachy System.
A first of its kind, the SCOUT MD localization system supports implantation of up to four unique reflector configurations. When implanted within abnormal breast or other soft tissue, the reflectors enable surgeons to pinpoint tumor location in multiple dimensions for more precise excision, minimizing trauma to healthy tissue and helping to reduce the likelihood of re-excision and the emotional and physical pain associated with a second surgery.
SCOUT? Access Guide Launches Globally
SCOUT’s global influence expands as the Access Guide makes its way to Australia. This new technology launched on a global scale allows physicians like Associate Professor Cindy Mak, Director of Breast Services and Head of Breast Surgery at Chris O'Brien Lifehouse, to treat more patients. Dr. Mak says, "I’ll be able to easily get it into my smaller axillary incisions for targeted axillary dissection now!"
The SCOUT Access Guide provides:
Clinical Utility and Millimeters Matter
The exceptional accuracy, depth capability, and overall utility of SCOUT provides you with the tools to excise precise specimens and treat patients throughout the continuum of care.
Precise Localization
SCOUT has a detection accuracy of ±1mm.
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Detection Accuracy and Depth Capability
The SCOUT Guide provides 360° detection of the reflector and a detection depth of 60mm regardless of the relationship between the Guide and the Reflector.
Ease of Use
SCOUT offers reliable, real-time distance measurements without signal interference from metal objects, and requires no system calibration.
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Clinically Insignificant MRI Artifact
SCOUT’s Reflector produces a clinically insignificant MRI Artifact, allowing it to be placed at biopsy or prior to neoadjuvant chemotherapy with no interference on MRI scans. With the recent release of SCOUT Bx, SCOUT is the only wire-free localization device that can be placed at time of biopsy under stereotactic or MRI guidance.
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