First Patient Enrolled in the Streamlined Localization (STREAMLoc) Registry Study Using SCOUT® at Biopsy in Canada
July 13 2022 - 9:25AM
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global
manufacturer and marketer of healthcare technology, announced today
the enrollment of the first patient in its Canadian prospective,
post-market, observational study to further demonstrate the
benefits of SCOUT, a wireless, radar-guided localization system
used to assist breast surgeons in identifying biopsied tumors for
removal during breast-conserving surgery.
Globally, over two million women were diagnosed
with breast cancer in 2020.1 Radar localization procedures may 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 may be able to
precisely target affected tissue. “I am looking forward to treating
patients and the positive outcomes of using the only radar
technology on the market," said Isabelle Trop, MD, a radiologist in
the Department of Radiology, Radiation Oncology, and Nuclear
Medicine at the University of Montreal, and investigator of the
STREAMLoc registry study.
The STREAMLoc registry study will add to the
body of research supporting the use of the SCOUT system to improve
efficiency in patient care between biopsy and surgery. This is of
high importance, particularly during the ongoing COVID-19 pandemic
which has imposed substantial logistical challenges to healthcare
delivery in Canada. “It is an easy one-step procedure before
surgery and a less painful and time-consuming technique on the day
of surgery,” said Christine Desbiens, MD, a surgical oncologist at
the CHU de Québec-Laval University and fellow investigator of the
STREAMLoc registry study.
STREAMLoc will enroll 500 patients with
high-risk breast lesions categorized as Breast Imaging Reporting
and Data System (BI-RADS) 4C or 5. Study outcomes will be assessed
from the initial placement of the SCOUT reflector during biopsy to
its removal. Subsequent pathology reports will include the impact
on the number of patient visits for invasive procedures between
biopsy and surgery and additional post-market data on safety and
efficacy of the system. Patient and clinician satisfaction with the
device will also be evaluated.
“The successful enrollment of the first patient
in the STREAMLoc registry study will add to our robust portfolio of
evidence regarding the benefits of the SCOUT system,” said Fred
Lampropoulos, Merit Medical’s Chairman and CEO. “We anticipate that
the safety and efficacy data collected, as well as data on patient
and provider satisfaction, will help us continue to improve the
clinical management of breast cancer.”
For additional information on the STREAMLoc
registry study, including ongoing updates, please visit:
https://clinicaltrials.gov/ct2/show/NCT04815291
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
more than 600 individuals. Merit employs approximately 6,500 people
worldwide with facilities in South Jordan, Utah; Pearland, Texas;
Richmond, Virginia; Rockland, Massachusetts; Aliso Viejo,
California; Maastricht and Venlo, The Netherlands; Paris, France;
Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville,
Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan;
Reading, United Kingdom; Johannesburg, South Africa; and
Singapore.
TRADEMARKS Unless noted otherwise,
trademarks and registered trademarks used in this release are the
property of Merit Medical Systems, Inc. and its subsidiaries in the
United States and other jurisdictions.
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
Reference1World Health Organization. 2021.
Breast cancer.
https://www.who.int/news-room/fact-sheets/detail/breast-cancer
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