Merit Medical Systems has achieved FDA clearance for its groundbreaking SCOUT MD Surgical Guidance System, a significant advancement in breast cancer care. This innovative system enhances tumor localization with precise accuracy, reducing the need for re-excision and improving patient outcomes. With over 500,000 devices distributed globally, Merit reaffirms its commitment to pioneering oncological solutions, driven by real-world evidence and physician feedback. The SCOUT MD system exemplifies Merit’s dedication to innovation and its mission to alleviate the burdens of breast cancer for patients worldwide.
Merit Medical Systems has reached a milestone in oncological innovation with the FDA clearance of its SCOUT MD Surgical Guidance System. This revolutionary system marks a transformative leap forward in breast cancer care, offering precise tumor localization to optimize surgical outcomes. With breast cancer’s staggering global prevalence and the significant impact of re-excision surgeries, the SCOUT MD system addresses a critical unmet need in oncology. By leveraging real-world evidence and physician insights, Merit continues to drive advancements that enhance patient experiences and redefine standards of care in breast cancer treatment.
The unveiling of the SCOUT MD system underscores Merit’s steadfast leadership in oncology and signifies a substantial leap forward in breast cancer management. Positioned as a cornerstone in Merit’s comprehensive oncology portfolio, the SCOUT MD system is meticulously engineered to augment the diagnosis and treatment of breast and soft tissue cancers. Noteworthy offerings within Merit’s oncology arm include the SCOUT Radar Localization System featuring the SCOUT Mini Reflector and SCOUT Bx Delivery System, along with the acclaimed SAVI Brachy System.
Distinguished by its groundbreaking capabilities, the SCOUT MD system facilitates the implantation of up to four distinct reflector configurations. These strategically positioned reflectors, when embedded within the abnormal breast or soft tissue, serve as precise locators, enabling surgeons to pinpoint tumor coordinates across multiple dimensions with unparalleled accuracy. This targeted precision not only mitigates damage to surrounding healthy tissue but also diminishes the likelihood of re-excision, thereby alleviating the emotional and physical toll associated with secondary surgeries.
Renowned breast surgical oncologist, Dr. John Vincent Kiluk of the Moffitt Cancer Center and USF, Tampa, Florida, lauded Merit’s innovation, stating, “Merit’s development of different reflectors with different signals will allow surgeons to better delineate the edges of resection.” He emphasized the potential of this surgical precision to enhance margin adequacy on larger tumors and reduce the necessity for subsequent surgeries, thereby optimizing patient outcomes.
Breast cancer remains a pervasive global health challenge, with a woman diagnosed every fourteen seconds worldwide. In 2020 alone, 2.3 million women received a breast cancer diagnosis, and 685,000 succumbed to the disease, making it the most prevalent cancer globally. Lumpectomy, a widely adopted form of breast-conserving surgery, is frequently employed for treatment. However, a staggering 20% to 30% of women undergoing lumpectomy require additional surgical interventions. Localization procedures, such as those facilitated by the SCOUT MD system, play a pivotal role in enabling surgeons to precisely target breast tumors, thereby fostering more efficacious surgeries and improved patient outcomes.
The introduction of the SCOUT MD system heralds a momentous milestone for Merit and breast surgery patients worldwide. As of January 2024, Merit has successfully distributed over 500,000 devices for utilization in inpatient procedures, underscoring its widespread impact and commitment to advancing oncological care.
Fred P. Lampropoulos, Chairman and CEO of Merit, expressed enthusiasm for the company’s momentum and its profound impact on breast cancer patients globally, stating, “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.” He underscored Merit’s dedication to leveraging innovative technologies, such as the SCOUT MD system, to enhance the patient experience and alleviate the burdens imposed by breast cancer on women worldwide. Lampropoulos affirmed Merit’s steadfast commitment to innovation and its ongoing pursuit of excellence in oncological care.
Merit Medical Systems’ achievement of FDA clearance for the SCOUT MD Surgical Guidance System heralds a new era in breast cancer care. With its unparalleled precision and ability to minimize re-excision rates, the SCOUT MD system holds promise for improving patient outcomes and reducing the emotional and physical burdens of breast cancer treatment. Merit’s commitment to innovation and its dedication to meeting the evolving needs of oncology patients worldwide underscores its pivotal role in advancing the fight against breast cancer. As Merit continues to innovate and refine its oncological solutions, the future of breast cancer care appears brighter, offering hope and healing to countless individuals affected by this pervasive disease.
