Merit Medical Receives CE Mark for Wrapsody™ Endovascular Stent Graft System
May 26 2020 - 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,
today announced that it received the CE mark for the WRAPSODY™
Endovascular Stent Graft System from the British Standards
Institution (BSI). The WRAPSODY system is a flexible self-expanding
endoprosthesis indicated for use in hemodialysis patients for the
treatment of stenosis or occlusion within central veins as well as
the dialysis outflow circuit of an arteriovenous (AV) fistula or AV
graft.
Merit has worked for almost eight years to
design, develop and establish the appropriate technology and
manufacturing capabilities for this product. Merit recently
completed enrollment and primary follow-up of its WRAPSODY FIRST
study which included 46 patients in Europe. Merit submitted an IDE
(Investigational Device Exemption) application to the FDA for its
review and consideration prior to the initiation of its WAVE
Pivotal Study. After completion of the WAVE pivotal study, Merit
intends to submit a PMA (Pre-Market Approval) application to the
FDA.
“We are pleased to receive this certificate and
the opportunity to offer this unique product to the European
community,” said Fred P. Lampropoulos, Merit’s Chairman and Chief
Executive Officer. “I want to thank the principal investigators of
the WRAPSODY FIRST study as well as our research and development,
medical affairs and regulatory affairs staff members who worked
tirelessly on this project.”
Merit intends to offer additional products
utilizing this technology platform, subject to additional
submissions and review by the FDA and the European Union notified
body.
Recently Merit received three Breakthrough
Device Designations covering indications and cohorts of the IDE for
the WRAPSODY system which have been filed with the FDA.
Merit intends to systematically introduce the
WRAPSODY system in Europe as procedures are resumed following the
ongoing lockdown due to COVID-19. Additionally, Merit also plans to
initiate registration activities associated with the system in
Australia, Canada and certain countries in Latin America. The
WRAPSODY system is complementary to other products that Merit
produces or distributes, such as the HeRO® Graft, the Surfacer®
Inside-Out® Access Catheter System and other vascular access
products.
ABOUT MERIT
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 300 individuals. Merit employs
approximately 6,100 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;
Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading,
United Kingdom; Johannesburg, South Africa; and Singapore.
FORWARD-LOOKING STATEMENTS
Statements contained in this release which are
not purely historical, including, without limitation, statements
regarding prospective regulatory clearances, approvals or
activities, Merit’s forecasted plans, development and
commercialization of new products, expansion of existing or future
product lines, the potential impact, scope and duration of, and
Merit’s response to, the coronavirus (COVID-19) pandemic and the
potential for recovery from that pandemic, 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, 2019 (as amended by an Amendment No. 1 to
Annual Report on Form 10-K/A, the “Annual Report on Form 10-K”) and
subsequent filings with the Securities and Exchange Commission.
Such risks and uncertainties include inherent risks and
uncertainties relating to Merit’s internal models or the
projections in this release; risks and uncertainties associated
with the COVID-19 pandemic; risks relating to Merit’s potential
inability to successfully manage growth through acquisitions
generally, including the inability to effectively integrate
acquired operations or products or commercialize technology
developed internally or acquired through completed, proposed or
future transactions; negative changes in economic and industry
conditions in the United States or other countries; 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; litigation and other judicial
proceedings affecting Merit; restrictions on Merit’s liquidity or
business operations resulting from its debt agreements;
infringement of Merit’s technology or the assertion that Merit’s
technology infringes the rights of other parties; actions of
activist shareholders, including a potential proxy contest; 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;
increases in the prices of commodity components; the potential of
fines, penalties or other adverse consequences if Merit’s employees
or agents violate the U.S. Foreign Corrupt Practices Act or other
laws or regulations; laws and regulations targeting fraud and abuse
in the healthcare industry; 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; changes in tax laws and
regulations in the United States or other countries; termination or
interruption of relationships with Merit’s suppliers, or failure of
such suppliers to perform; fluctuations in exchange rates;
uncertainties relating to the LIBOR calculation method and the
expected discontinuation of LIBOR; concentration of a substantial
portion of Merit’s revenues among a few products and procedures;
development of new products and technology that could render
Merit’s existing or future products obsolete; market acceptance of
new products; volatility in the market price of Merit’s common
stock; modification or limitation of governmental or private
insurance reimbursement policies; changes in healthcare policies or
markets related to healthcare reform initiatives; failure to comply
with applicable environmental laws; 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 referenced in Merit’s Annual Report on Form 10-K
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.
Date: |
May 26, 2020 |
Contact: |
Anne-Marie Wright, Vice President, Corporate
Communications |
Phone: |
(801) 208‑4167 e-mail: awright@merit.com Fax: (801)
253‑1688 |
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