WESTBURY, N.Y., Jan. 6, 2014 /PRNewswire/ -- Vasomedical,
Inc. ("Vasomedical") (OTCBB: VASO), a diversified medical
technology company specializing in the design, manufacture and sale
of medical devices including EECP® (Enhanced External
Counterpulsation) Therapy systems, the gold standard of ECP
therapy, announced today that the U.S. Food and Drug Administration
(FDA), Department of Health and Human Services, issued its final
order on December 30, 2013,
reclassifying external counter-pulsating (ECP) devices for
treatment of chronic stable angina for patients that are refractory
to anti-anginal medical therapy and without options for
revascularization from class III to class II (special
controls).
Under a number of federal regulations, FDA administers a
comprehensive system for the regulation of medical devices intended
for human use. The system established three categories
(classes) of devices, reflecting the regulatory controls needed to
provide reasonable assurance of their safety and effectiveness,
namely general controls (class I), special controls (class II) and
premarket approval or PMA (class III). FDA's reclassification
of ECP devices for treatment of refractory angina, which was a
preamendments class III device, into class II is based upon its
conclusion that the available scientific evidence is adequate to
support the safety and effectiveness of ECP devices for this
specific intended use.
In addition, FDA in the final order is requiring the filing of a
PMA or a notice of completion of a product development protocol
(PDP) for ECP devices for other intended uses such as unstable
angina, acute myocardial infarction, cardiogenic shock and
congestive heart failure, which were previously cleared for
marketing by means of premarket notification (510(k)) procedure.
In accordance with federal regulations, ECP manufacturers may
continue to commercially distribute their devices for these
intended uses for a period of 90 days after the issuance of the
final order. The devices may continue to be marketed only for
refractory angina if a PMA or a notice of completion of a PDP is
not filed before the end of the 90-day period.
"The reclassification of ECP devices is long overdue, and we
thank FDA for confirming once again the safety and efficacy of ECP
treatment of refractory angina in its class II decision," stated
Dr. Jun Ma, President and CEO of
Vasomedical, Inc. "Until this FDA final order, ECP systems, as a
class III preamendments device, had been cleared for marketing in
the U.S. by the 510(k) procedure, which only requires a
demonstration of substantial equivalence. Consequently,
certain manufacturers have been marketing their devices without
much, if any, clinical evidence, which ultimately hurt the
reputation of external counterpulsation therapy, a great technology
if done right, as we have seen in numerous cases."
"The requirement of a PMA, which requires device-specific
clinical evidence, for intended uses of ECP devices other than
refractory angina is a positive development for Vasomedical and for
patients that receive the therapy. We believe, since almost
all of the publicly available scientific and clinical studies as
published in peer reviewed medical journals and conferences were
generated using Vasomedical EECP systems, there is sufficient
clinical data for the Company to immediately proceed with the
preparation of PMA applications or PDP filings for certain
indications other than refractory angina," Dr. Ma continued.
"With this final order by FDA and given the breadth of clinical
evidence for our EECP Therapy, we appreciate the opportunity to
distinguish, from a regulatory standpoint now, our EECP Therapy
system from other external counterpulsation (ECP) devices."
About Vasomedical
Vasomedical, Inc. is a diversified
medical technology company specializing in the manufacture and sale
of medical devices and in the domestic sale of diagnostic imaging
products. The Company's main proprietary products are
EECP® Therapy systems, the gold standard of ECP
treatment. The Company operates through three wholly owned
subsidiaries: VasoSolutions, Vasomedical Global and VasoHealthcare.
VasoSolutions manages and coordinates the design, manufacture and
sales of EECP® Therapy systems, and other medical
equipment operations; Vasomedical Global operates the
Company's China-based subsidiaries; and VasoHealthcare is the
operating subsidiary for the exclusive sales representation of GE
Healthcare diagnostic imaging products in certain markets.
Additional information is available on the Company's website
at www.vasomedical.com
Except for historical information contained in this release,
the matters discussed are forward-looking statements that involve
risks and uncertainties. When used in this release, words such as
"anticipates", "believes", "could", "estimates", "expects", "may",
"plans", "potential" and "intends" and similar expressions, as they
relate to the Company or its management, identify forward-looking
statements. Such forward-looking statements are based on the
beliefs of the Company's management, as well as assumptions made by
and information currently available to the Company's management.
Among the factors that could cause actual results to differ
materially are the following: the effect of business and economic
conditions; the effect of the dramatic changes taking place in the
healthcare environment; the impact of competitive procedures and
products and their pricing; medical insurance reimbursement
policies; unexpected manufacturing or supplier problems; unforeseen
difficulties and delays in the conduct of clinical trials and other
product development programs; the actions of regulatory authorities
and third-party payers in the United States and overseas;
uncertainties about the acceptance of a novel therapeutic modality
by the medical community; continuation of the GEHC agreement; and
the risk factors reported from time to time in the Company's SEC
reports. The Company undertakes no obligation to update
forward-looking statements as a result of future events or
developments.
Investor Contacts:
Todd Fromer / Garth
Russell
KCSA Strategic Communications
212-896-1215 / 212-896-1250
tfromer@kcsa.com / grussell@kcsa.com
Media Contact:
Samantha
Wolf
KCSA Strategic Communications
212-896-1220
swolf@kcsa.com
SOURCE Vasomedical, Inc.