Merit Medical Receives FDA 510(k) Clearance for SCOUT® MD™ Surgical Guidance System
15 Fevereiro 2024 - 11:25AM
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 InquiriesSarah ComstockMerit Medical+1-801-432-2864
| sarah.comstock@merit.com
INVESTOR INQUIRIESMike Piccinino, CFA, IRCWestwicke -
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)
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