Merit Medical Receives FDA Breakthrough Device Designation for WRAPSODY™ Endovascular Stent Graft System
November 21 2019 - 9:25AM
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer
and marketer of proprietary disposable devices used in
interventional, diagnostic and therapeutic procedures, particularly
in cardiology, radiology, oncology, critical care and endoscopy,
announced today that it has been granted Breakthrough Device
Designation by the U.S. Food and Drug Administration (FDA) for the
Merit WRAPSODY™ Endovascular Stent Graft System. The WRAPSODY
system is a flexible, self-expanding endoprosthesis for which Merit
intends to seek indication for use in hemodialysis patients for the
treatment of stenosis within the central veins of the outflow
circuit of an arteriovenous fistula (AVF) up to the superior vena
cava.
The FDA Breakthrough Devices Program is intended
to help patients receive more timely access to breakthrough
technologies that have the potential to provide more effective
treatment or diagnosis for life-threatening or irreversibly
debilitating diseases or conditions. Under the program, the FDA
provides priority review and interactive communication regarding
device development and clinical trial protocols, through to
commercialization decisions. The WRAPSODY system is nearing
completion of its “First in Man” studies, and is not currently
available for sale.
“We are pleased with the recognition by the FDA
of this worthwhile technology as well as the efforts of many
members of our R&D team to bring the project to this point,”
said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO. “Most
importantly, we believe this system will provide substantial
benefits to patients who may be treated with it in the future.”
ABOUT MERITFounded 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 300
individuals. Merit employs approximately 6,350 people
worldwide with facilities in South Jordan, Utah; Pearland, Texas;
Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts;
Aliso Viejo, California; Maastricht and Venlo, The Netherlands;
Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico;
Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia;
Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa;
and Singapore.
FORWARD-LOOKING
STATEMENTSStatements contained in this release
which are not purely historical, including, without limitation,
statements regarding the development, introduction or
commercialization of new products, are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 and are subject to risks and uncertainties such as those
described in Merit’s Annual Report on Form 10‑K for
the year ended December 31, 2018 and subsequent filings
with the Securities and Exchange Commission. Such risks and
uncertainties include inherent risks and uncertainties relating to
Merit’s potential inability to successfully commercialize
technology developed internally or acquired through completed,
proposed or future transactions; expenditures relating to research,
development, testing and regulatory approval or clearance of
Merit’s products and risks that such products may not be developed
successfully or approved for commercial use; governmental scrutiny
and regulation of the medical device industry, including
governmental inquiries, investigations and proceedings involving
Merit; infringement of Merit’s technology or the assertion that
Merit’s technology infringes the rights of other parties; product
recalls and product liability claims; changes in customer
purchasing patterns or the mix of products Merit sells; risks and
uncertainties associated with Merit’s information technology
systems, including the potential for breaches of security and
evolving regulations regarding privacy and data protection; the
pending exit of the United Kingdom from the European Union and
uncertainties about when, how or if such exit will occur; potential
for significant adverse changes in governing regulations, including
reforms to the procedures for approval or clearance of Merit’s
products by the U.S. Food & Drug Administration or
comparable regulatory authorities in other jurisdictions; increases
in the prices of commodity components; negative changes in economic
and industry conditions in the United States or other countries;
termination or interruption of relationships with Merit’s
suppliers, or failure of such suppliers to perform; development of
new products and technology that could render Merit’s existing or
future products obsolete; market acceptance of new products;
modification or limitation of governmental or private insurance
reimbursement policies; changes in healthcare policies or markets
related to healthcare reform initiatives; changes in key personnel;
work stoppage or transportation risks; introduction of
products in a timely fashion; price and product competition;
availability of labor and materials; fluctuations in and
obsolescence of inventory; and other factors referred to in Merit’s
Annual Report on Form 10‑K for the year ended
December 31, 2018 and other materials filed with the
Securities and Exchange Commission. All subsequent forward-looking
statements attributable to Merit or persons acting on its behalf
are expressly qualified in their entirety by these cautionary
statements. Actual results will likely differ, and may differ
materially, from anticipated results. Financial estimates are
subject to change and are not intended to be relied upon as
predictions of future operating results, and Merit assumes no
obligation to update or disclose revisions to those estimates.
Contact:Phone: |
Anne-Marie
Wright, Vice President, Corporate Communications(801)
208-4167 e-mail: awright@merit.com Fax: (801)
253-1688 |
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