FOCUSED ON CREATING BETTER OUTCOMES
Neovasc is focused on creating better outcomes for difficult-to-treat cardiology patients through the development of two novel products: Reducer™* for treatment of refractory angina and the Tiara™ System* for treatment of mitral valve regurgitation.
*Reducer is not available in every geography. For investigational use only in the United States.
Important safety information may be found here>
The Tiara System is not commercially available and is for investigational use only.
Neovasc Presentation at this year’s EuroPCR Symposium:
NEOVASC REDUCERTM
Millions of patients worldwide with coronary artery disease who are not candidates for revascularization suffer from refractory angina despite receiving optimal medical therapy.
Before Neovasc’s Reducer,* there were limited real options for treating refractory angina. Reducer is a small, balloon-expandable, hourglass-shaped device that establishes a narrowing in the coronary sinus. The resulting increase in back pressure redistributes blood into the ischemic myocardium. See how it works >.
Reducer is CE-marked in Europe and has been implanted in over 2,000 patients. It is currently under clinical investigation in the US.
*Reducer is not available in every geography. For investigational use only in the United States.
Important safety information may be found here>
MULTI-CENTER STUDIES
COSIRA Prospective Randomized Trial
(COronary SInus Reducer for treatment of Refactory Angina)
Beginning in 2010, Neovasc and clinicians worldwide began studying the safety and efficacy of the Reducer* device. 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina and myocardial ischemia who were not candidates for revascularization were enrolled. One randomized group received the device (treatment group) while another received a sham procedure (control group). COSIRA demonstrated that patients receiving the Reducer device achieved a statistically significant improvement in angina symptoms and quality of life compared to patients in a sham control group¹.
%
of patients improved 1 or more CCS angina classes at 6 months
%
of patients improved 2 or more CCS angina classes at 6 months
71% of patients improved at least one CCS angina classes 6 months after Reducer implantation
35% of patients improved at least two CCS angina classes 6 months after Reducer implantation
Quality of Life improved 17.6 points for patients who received the implant, vs. 7.6 points for patients in the control group.
COSIRA full results can be read here >
REDUCER-I Prospective, Multi-Center, Post-Market Study
In September 2021, interim results from the REDUCER-I trial augmented the findings from the initial COSIRA trial². Patients were enrolled at 20 centers and followed up to 2 years.
%
of patients improved 1 or more CCS angina classes at 2 years
%
of patients improved 2 or more CCS angina classes at 2 years
82% of patients improved at least one CCS angina classes 2 years after Reducer implantation
31% of patients improved at least two CCS angina classes 2 years after Reducer implantation
REDUCER-I interim results can be read here >
COSIRA-II Multi-Center Study
COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for patients suffering from refractory angina. The study is planned to enroll approximately 380 patients at up to 50 sites in the United States beginning in 2022. More information is available here >.
¹Stefan Verheye, MD, PhD; Pierfrancesco Agostoni, MD; Francesco Giannini, MD; Jonathan M. Hill, MD; Christoph Jensen, MD; Steven Lindsay, MD; Pieter R. Stella, MD; Simon Redwood, MD; Shmuel Banai, MD; Maayan Konigstein, MD. Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study. EuroIntervention 2021;17:561-568. DOI: 10.4244/EIJ-D-20-00873
²Verheye S, Jolicoeur EM, Behan MW, et al. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med 2015; 372: 519–527
*Reducer is not available in every geography. For investigational use only in the United States.
Important safety information may be found here>
PUBLISHED RESULTS
Published results may be viewed on a desktop computer or tablet.
NEOVASC TIARATM SYSTEM*
Novel Mitral Valve Replacement System
Neovasc is developing the Tiara™ System* for the treatment of severe mitral valve regurgitation (MR), a condition that affects approximately four million patients in the U.S. alone. Currently, conventional surgical treatments are only appropriate for about 20% of these patients, leaving the majority of patients untreated.
No Audio Available
*Tiara™ is not commercially available and is for investigational use only.
The Tiara device is delivered through the apex of the heart to replace the mitral valve while preserving the integrity of the surrounding structures of the heart. Tiara has been designed specifically to address the myriad of challenges inherent to the treatment of MR, as well as meeting the need for transcatheter replacement of the mitral valve. Tiara implantation is achieved through a transapical approach and does not typically require any hemodynamic support.
NEOVASC TIARATM SYSTEM*
Novel Mitral Valve Replacement System
Neovasc is developing the Tiara™ System for the treatment of severe mitral valve regurgitation (MR), a condition that affects approximately four million patients in the U.S. alone. Currently, conventional surgical treatments are only appropriate for about 20% of these patients, leaving the majority of patients untreated.
The Tiara device is delivered through the apex of the heart to replace the mitral valve while preserving the integrity of the surrounding structures of the heart. Tiara has been designed specifically to address the myriad of challenges inherent to the treatment of MR, as well as meeting the need for transcatheter replacement of the mitral valve. Tiara implantation is achieved through a transapical approach and does not typically require any hemodynamic support.
No Audio Available
*Tiara™ is not commercially available and is for investigational use only.