Neovasc Announces FDA Advisory Panel Result on Neovasc Reducer™ Medical Device for the Treatment of Refractory Angina
via NewMediaWire -- Neovasc Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) today announced that the United
States Food and Drug Administration’s (FDA’s) Circulatory
System Devices Advisory Panel voted 14 to 4 “in favor” that the
Neovasc Reducer™ is safe when used as intended, and voted 1 to 17
"against" on the issue of a reasonable assurance of effectiveness.
The third vote was 13 to 3 "against” (2 abstained) on whether the
relative benefits outweighed the relative risks.
“We would like to thank the FDA, the panel and members of the
public that offered their insights during yesterday’s Circulatory
System Devices Advisory Panel meeting,” said Fred Colen, President
and Chief Executive Officer of Neovasc. “Clearly, we are
disappointed with the meeting’s outcome, and we will provide
further updates in the coming weeks.”
The Reducer is currently under review by the
agency for treatment of patients with refractory angina pectoris
despite guideline directed medical therapy, who are unsuitable for
revascularization by coronary artery bypass grafting or by
percutaneous coronary intervention.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing
cardiovascular marketplace. The Company is a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, and minimally invasive devices for the
treatment of refractory angina. Its products include the Neovasc
Reducer™, for the treatment of refractory angina, which is not
currently commercially available in the United States (2 U.S.
patients have been treated under Compassionate Use) and has been
commercially available in Europe since 2015, and Tiara™, for the
transcatheter treatment of mitral valve disease, which is currently
under clinical investigation in the United States, Canada, Israel
and Europe. For more information,
visit: www.neovasc.com. Click here for a link to the
most recent corporate update.
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forward-looking statements within the meaning of the U.S. Private
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factors should be considered carefully, and readers should not
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