Merit Medical Receives 510(k) Clearance for the SwiftNINJA™ Steerable Microcatheter
November 07 2016 - 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 and endoscopy, today announced that it has
received 510(k) clearance for the SwiftNINJA™ Steerable
Microcatheter. The clearance covers peripheral and coronary
applications. With the exception of Japan, Merit has global
distribution rights for the SwiftNINJA.
“For the past several months we have been
marketing this unique product with great success in Europe,” said
Fred P. Lampropoulos, Merit’s Chairman and Chief Executive
Officer. “Physician response relating to range, convenience
and overall cost, when compared to the use of multiple devices, has
validated our initial expectations.”
The SwiftNINJA is scheduled to be launched
simultaneously with the Corvocet™ Biopsy System, which also
received 510(k) clearance recently.
“We believe these two patented and
transformative technologies will provide substantial momentum and
enthusiasm amongst our sales force and customers as we prepare for
2017,” Lampropoulos said.
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 and endoscopy. Merit serves client
hospitals worldwide with a domestic and international sales force
totaling approximately 200 individuals. Merit employs
approximately 4,100 people worldwide with facilities in South
Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern,
Pennsylvania; Rockland, Massachusetts; San Jose, California;
Maastricht and Venlo, The Netherlands; Paris, France; Galway,
Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil;
Markham, Ontario, Canada, and Melbourne, Australia.
Statements contained in this release which are
not purely historical, including, without limitation, statements
regarding Merit's forecasted plans, revenues, net income, financial
results or anticipated or completed acquisitions, 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, 2015. Such risks
and uncertainties include risks relating to Merit's potential
inability to successfully manage growth through acquisitions,
including the inability to commercialize technology acquired
through completed, proposed or future transactions (including the
recently completed acquisition of DFINE); product recalls and
product liability claims; 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; reforms to the 510(k) process administered by the U.S. Food
and Drug Administration; restrictions on Merit's liquidity or
business operations resulting from its current debt agreements;
infringement of Merit's technology or the assertion that Merit's
technology infringes the rights of other parties; 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; changes in tax laws and
regulations in the United States or other countries; 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; fluctuations in
exchange rates; 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
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 referred to in Merit's Annual Report on Form 10-K for the
year ended December 31, 2015 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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