Merit Medical Systems Announces Four Regulatory Approvals
February 20 2020 - 9:25AM
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer
and marketer of proprietary disposable devices used primarily in
cardiology, radiology and endoscopy, announced today that
regulatory clearances have been issued with respect to four
products Merit owns or holds the rights to distribute.
Merit received clearance from the China National Medical
Products Association (NMPA) to market the Swift Ninja™ Steerable
Microcatheter in China. This device previously received clearance
in the United States as well as the European Union (CE mark).
The Swift Ninja has received strong reviews for its time efficiency
as well as the ability to employ its steerable characteristics to
access difficult or tortuous anatomy.
Secondly, the NMPA also gave Merit clearance to market in China
the InQwire® Amplatz Guide Wire, which has been selling
successfully in the United States and Europe.
“Although it has taken some time to receive these approvals,
they are complementary to our peripheral product offering,
especially our embolic products,” said Fred P. Lampropoulos,
Merit’s Chairman and CEO.
Thirdly, Merit received the CE mark for its Cianna Scout®
Surgical Guidance System. Initial procedures utilizing the Scout
Surgical Guidance System have been completed in Great Britain with
preparations to launch the Scout Surgical Guidance System
throughout the EU over the next several weeks.
“In an environment where international approvals are becoming
more difficult to obtain, we are pleased to add these to our
product portfolio,” Lampropoulos said.
Finally, Merit received notice from BlueGrass Vascular
Technologies, Inc. (Bluegrass Vascular) that the FDA has granted to
Bluegrass Vascular a De Novo classification order for its Surfacer®
Inside-Out® Access Catheter System. Merit owns approximately 19% of
the common equity of BlueGrass Vascular and has been the worldwide
exclusive distributor of the system for the last three years. Merit
has the option to acquire the remaining equity of Bluegrass
Vascular within the next two months. Merit plans to evaluate the
Surfacer Inside-Out System in several U.S. accounts and feature the
system at the Society of Interventional Radiology (SIR) meetings
scheduled to take place in Seattle March 28-April 2. Additional
information about the Surfacer Inside-Out System can be obtained by
visiting https://bluegrassvascular.com/.
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 6,400 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 STATEMENTS
Statements contained in this release which are not purely
historical, including, without limitation, statements regarding the
issuance of regulatory clearances and anticipated consequences of
Merit’s sale of products authorized thereby, the commercialization,
marketing, evaluation and sale of medical devices owned or
distributed by Merit, or Merit’s rights with respect to Bluegrass
Vascular and its 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; 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; litigation or other judicial proceedings
affecting Merit, its operations or its financial condition;
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: |
Anne-Marie
Wright, Vice President, Corporate Communications |
Phone: |
(801) 208-4167 e-mail: awright@merit.com Fax: (801)
253-1688 |
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