FDA Approves Wire-free Breast Localization Solution for Biopsy

By News Release

Merit Medical Systems, Inc. announced FDA clearance for its SCOUT Bx Delivery System, which according to the company is the first wire-free breast localization solution that can be deployed at the time of stereotactic or MRI-guided biopsy. The company also says SCOUT is the only localization system cleared for long-term implant status for breast and soft tissue.

Each year more than 300,000 women undergo surgery related to breast cancer. Radar localization procedures help physicians surgically remove abnormal tissue while minimizing trauma to surrounding healthy tissue. By implanting a tiny reflector, the size of a grain of rice, physicians can precisely target affected tissue, resulting in more successful surgeries and improved patient outcomes. Today, roughly 40 percent of breast biopsies are performed under stereotactic or MRI guidance, creating the need for an additional office visit for reflector placement prior to surgery. SCOUT Bx is compatible with the most commonly used stereotactic and MRI guided breast biopsy devices on the market, allowing the patient to avoid an additional procedure.

Brett T. Parkinson, MD, diagnostic radiologist at Intermountain Healthcare in Salt Lake City, UT and a consultant of Merit, has been a leader in developing protocols to place SCOUT reflectors at time of biopsy. “Patients appreciate that they do not have to return to the breast center for a second procedure at a stressful time in their treatment planning,” said Dr. Parkinson. “The SCOUT Bx system is designed to allow clinicians to offer this streamlined pathway to a broader group of patients. This benefits patients as well as the healthcare system."

The SCOUT Bx system is the newest addition to the Merit Oncology Breast and Soft Tissue Localization portfolio. Merit Oncology offers a wide range of localization and brachytherapy technologies to meet diverse clinical needs. Merit recently launched the SCOUT Mini Reflector which is optimally sized for lymph node placement.

“The SCOUT System is the market leader in wire-free breast surgical localization. Merit is committed to maintaining this leadership through continuous innovation to advance and streamline treatment for cancer patients,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO. “Placement at the time of biopsy lessens the burden on cancer patients and benefits healthcare providers. The SCOUT Bx system expands this important treatment option to more patients. Merit is proud to be the first to market with this solution.”

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FDA Approves Wire-free Breast Localization Solution for Biopsy .  Appl Radiol. 

By News Release| April 12, 2022

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