Neovasc, Inc (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that its Tiara transcatheter mitral valve replacement device and its Neovasc Reducer CE-Marked device for the treatment of refractory angina will be featured in multiple presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 scientific symposium, which takes place September 25-29, 2019, in San Francisco.
“We are excited that our core products, Tiara and Reducer, will be prominently featured at TCT, the largest and most prestigious interventional cardiology conference in North America,” said Fred Colen, President and Chief Executive Officer of Neovasc. “Our team looks forward to interacting with many of the leading cardiologists from around the globe.”
Select Presentations:
Tiara
In Session I, “TMVR Overview and Principle Devices,” Anson Cheung, M.D., Professor of Surgery, University of British Columbia, Canada, and Director of Cardiac Transplant and Mechanical Circulatory Assist Program of British Columbia, will deliver a presentation entitled, “Tiara: Device Description, Results, and Ongoing Studies,” on Saturday, September 28, 2019, at 2:27 PM PT.
Reducer
In a Moderated Poster Session, “Chronic Total Occlusions,” on Friday, September 27, 2019, at 2:30 PM PT, Dr. Carlo Zivelonghi will deliver a presentation entitled, “Efficacy of Coronary Sinus Reducer in Patients with non-Revascularized Chronic Total Occlusions: a Multicentre Experience.”
In an International Complex Case Session, “Featured Complex Coronary Cases,” on Friday, September 27, 2019, at 4:50 PM PT, Prof. Matjaz Bunc of Ljubljana University Medical Centre in Slovenia will deliver a presentation entitled, “Multimodal Treatment of Refractory Angina Pectoris With Coronary Flow Reducer Implantation.”
About Tiara
Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients affected throughout Europe. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.
The Tiara valve is currently being evaluated in two ongoing clinical trials: TIARA-In early feasibility trial in the United States, Canada, and Belgium; and TIARA-II a European Conformit Europ enne Mark Trial in Germany, Italy, Spain, and the United Kingdom. In addition, patients have also been treated under compassionate programs in Canada, Italy, Germany, Israel, and Switzerland.
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 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.
While the Reducer is not approved for commercial use in the USA, the U.S. Food and Drug Administration granted Breakthrough Device designation to the Neovasc 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.
