Merit Medical’s Embosphere® Microspheres Receive FDA 513(f)(2) (de novo) Classification for Prostatic Artery Embolization...
June 22 2017 - 9:29AM
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 513(f)(2) (de novo) classification from the FDA to expand
indication for Merit’s Embosphere® Microspheres. The
indication now includes prostatic artery embolization (PAE) for
symptomatic benign prostatic hyperplasia (BPH).
“Merit’s Embosphere is the first embolic agent to receive FDA
513(f)(2) classification for prostatic artery embolization,
providing a non-surgical treatment option for millions of men who
suffer from BPH,” said Fred P. Lampropoulos, Merit’s Chairman and
Chief Executive Officer.
BPH is an enlarged prostatic gland and can cause lower urinary
tract symptoms for more than half of all men in their 60s and as
many as 90% of men over age 70.1 The PAE procedure is
performed through a tiny incision in the patient’s upper thigh or
wrist, and uses Embosphere Microspheres to occlude the prostatic
arteries, reducing their blood supply and causing the prostate to
shrink and improve symptoms.
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 290 individuals. Merit employs
approximately 4,500 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; Melbourne, Australia; Tokyo, Japan; and
Singapore.
FORWARD-LOOKING STATEMENTS
Statements contained in this release which are
not purely historical 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,
2016 and subsequent filings with the Securities and Exchange
Commission. 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; 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; and fluctuations in and
obsolescence of inventory. 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.
REFERENCES
- McWilliams, J. P., Kuo, M. D., Rose, S.C., Bagla, S.,
Caplin, D. M., Cohen, E. I., Faintuch, S., Spies, J. B., Saad, W.
E., Nikolic, B. (2014). Society of Interventional Radiology
position statement: prostate artery embolization for treatment of
benign disease of the prostate. Journal of Vascular and
Interventional Radiology, 25: 1349-1351.
http://dx.doi.org/10.1016/j.jvir.2014.05.005
http://www.scvir.org/clinical/cpg/SIR_Pos_Statmt_PAE_Benign_dis_Prostate.pdf
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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