Post by icemandios on Jun 20, 2018 12:59:01 GMT
Neovasc Announces First Implant of a Neovasc Reducer™ in a U.S. Patient
NASDAQ, TSX: NVCN
VANCOUVER, June 20, 2018 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, today announced the first U.S. patient has been implanted with a Neovasc Reducer™ (the "Reducer"), a CE-Marked medical device for the treatment of refractory angina. The Compassionate Use case was conducted by Dr. Gerald Koenig, along with Dr. Ryan Gindi and colleagues, of the Division of Cardiology at Henry Ford Hospital in Detroit, Michigan.
Dr. Koenig commented "This patient has severe coronary artery disease and has suffered from refractory angina for a few years. The condition has had a significant impact on his quality of life during this time, with little to no relief from multiple other widely accepted treatment options."
"This novel device has accumulating evidence supporting the physiological basis and associated clinical benefit. My experience with the Reducer during the procedure, was very positive. The process is similar to implanting a stent. In terms of the patient, he tolerated the procedure very well and had no complications," concluded Dr. Koenig.
"We are pleased to provide this patient the opportunity to receive a Reducer implanted under Compassionate Use. As our studies and patients in multiple geographies, including Europe, Israel and Saudi Arabia, have shown, this device offers angina sufferers the potential to improve exercise capacity and resume a normal life, free of the pain and discomfort that has often limited their ability to perform normal daily activities," commented Fred Colen, Neovasc's President and Chief Executive Officer. "The Reducer continues to gain attention from medical professionals around the world as the number of patient cases have increased with the scaling of our commercial activities."
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.1
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac 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.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe. For more information, visit: www.neovasc.com.
1T. J. Povsic, S. Broderick, K. J. Anstrom et al., "Predictors of long‐term clinical endpoints in patients with refractory angina," Journal of the American Heart Association, vol. 4, no. 2, article e001287, 2015.
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SOURCE Neovasc Inc.
Source: PR Newswire (Jun 20, 2018 07:30:00 EDT)
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