Merit Medical Receives FDA 510(k) Clearance for SCOUT® MD™ Surgical Guidance System
Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, has received US Food and Drug Administration (FDA) 501(k) clearance for the SCOUT® MD™ Surgical Guidance System.
The release of the new guidance system demonstrates Merit’s ongoing leadership in oncology and marks a significant advancement in breast cancer care. SCOUT MD broadens Merit’s oncology portfolio, designed to enhance diagnosis and treatment of breast and other soft tissue cancers. Products include the SCOUT Radar Localization System with SCOUT Mini Reflector and SCOUT Bx™ Delivery System as well as the SAVI® Brachy System.
A breakthrough solution, SCOUT MD supports implantation of up to four different reflector configurations. When implanted within abnormal breast or other soft tissue, the reflectors are designed to pinpoint tumor location in multiple dimensions for more precise excision. A targeted approach can help minimize damage to surrounding healthy tissue, decrease the likelihood of re-excision, and avoid the emotional and physical trauma associated with a second surgery.
“Merit’s development of different reflectors with different signals will allow surgeons to better delineate the edges of resection,” said John Vincent Kiluk, MD, FACS, Breast Surgical Oncologist at the Moffitt Cancer Center and Professor of Oncologic Sciences at USF, Tampa, Florida. “The subsequent result of this surgical precision should improve a surgeon’s ability to obtain adequate margins on larger tumors and decrease the need for repeat surgery.”
Every fourteen seconds, a woman is diagnosed with breast cancer.1 In 2020, 2.3 million women were diagnosed, and 685,000 died of breast cancer globally, making it the world’s most prevalent cancer.2 Lumpectomy (a type of breast-conserving surgery) is often performed as treatment. However, an estimated 20% ̶ 30% of women who undergo lumpectomy will need a repeat surgery.3 Localization procedures help surgeons precisely target breast cancer, which may result in more successful surgeries and improved patient outcomes.
The release of SCOUT MD coincides with an important milestone for Merit and breast surgery patients worldwide. As of January 2024, Merit has distributed more than 500,000 devices for placement in patient procedures.
“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’s Chairman 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.”
ABOUT MERIT MEDICAL Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 700 individuals. Merit employs approximately 7,000 people worldwide.
TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.
CONTACTS
PR/Media Inquiries
Sarah Comstock
Merit Medical
+1-801-432-2864 | sarah.comstock@merit.com
INVESTOR INQUIRIES
Mike Piccinino, CFA, IRC
Westwicke - ICR
+1-443-213-0509 | mike.piccinino@westwicke.com
References
1. Breast Cancer Research Foundation. 2023. “Breast Cancer Statistics and Resources.” https://www.bcrf.org/breast-cancer-statistics-and-resources/
2. World Health Organization. 26 Mar 2021. “Breast Cancer.” https://www.who.int/news-room/fact-sheets/detail/breast-cancer
3. Havel et al. 2019. “Impact of the SSO-ASTRO Margin Guideline on Rates of Re-Excision after Lumpectomy for Breast Cancer: a Meta-Analysis.” Annals of Surgical Oncology 26 (5): 1238 ̶ 1244. (PMID: 30790112)
