Neovasc Announces Circulatory System Devices Panel Meeting Date for Neovasc Reducer™ Device
Neovasc announced that the U.S. FDA will review its premarket approval application for the Neovasc Reducer device on October 27, 2020. This device aims to treat patients with refractory angina pectoris who cannot undergo coronary artery bypass grafting or percutaneous coronary intervention. The Reducer has received Breakthrough Device designation from the FDA. Currently CE-marked in Europe, it may significantly alleviate symptoms for 600,000 to 1.8 million Americans affected by this debilitating condition. CEO Fred Colen highlights the importance of this milestone for Neovasc.
- FDA scheduled a review of the premarket approval application for the Neovasc Reducer on October 27, 2020.
- Neovasc Reducer has Breakthrough Device designation from the FDA, expediting its development.
- The Reducer is CE-marked for use in the EU and has been commercially available since 2015.
- The Reducer is not yet approved for commercial use in the U.S., limiting its market availability.
VANCOUVER and MINNEAPOLIS, July 09, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Neovasc, Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that the Circulatory System Devices Panel of the Medical Devices Advisory Committee will review the premarket approval application (PMA) for the Neovasc Reducer™ device (“Reducer”) at its October 27, 2020 meeting. Neovasc is seeking approval for Reducer in the U.S. for the treatment of patients suffering from refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting (CABG) or by percutaneous coronary intervention (PCI).
“Today’s announcement marks a significant milestone for Neovasc, as we continue to work closely with the FDA towards approval of the Reducer in the United States,” said Fred Colen, President and Chief Executive Officer of Neovasc. “We look forward to discussing the role that Reducer can play in alleviating the suffering that refractory angina patients endure.”
The FDA granted Breakthrough Device designation to the Reducer for the treatment of refractory angina in October 2018. Neovasc submitted a PMA for the Reducer device in December 2019.
About Reducer
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when there is inadequate supply of blood to parts of the heart muscle, despite current treatment therapies, including any form of standard revascularization and drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow in the heart’s circulatory system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and is completed in approximately 20 minutes.
While the Reducer is not approved for commercial use in the United States, it is currently under PMA review. The FDA granted Breakthrough Device designation to the Reducer in October 2018. This designation is granted by the FDA in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.
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.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words "expect", "anticipate", "estimate", "may", "will", "should", "intend," "believe", and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the growing incidence of refractory angina, potential FDA approval of the Reducer in the United States and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward looking statements, including those described in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Management's Discussion and Analysis for the three months ended March 31, 2020 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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FAQ
What is the Neovasc Reducer device and its purpose?
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