The Reducer system is designed to alter blood flow in the heart’s circulatory system to increase perfusion of oxygenated blood to ischemic areas of heart muscle, and can be placed in a minimally invasive transvenous procedure, the Vancouver-based company said.
Results from the trial, titled Reduce, was published in the International Journal of Cardiology.
The trial explored the use of the device amongst a real-world cohort of 141 patients from three centers in Milan, Teal Aviv and Antwerp, with aims to evaluate the efficacy of the device in improving quality of life and reducing symptoms of angina pectoris. The safety endpoint of the trial was to evaluate the rate of successful Reducer delivery and deployment in absence of device-related events.
Results from the study indicated that treatment with the Reducer was safe and effectively reduced angina severity as measured by the Canadian Cardiovascular Society classification, with 81% of patients showing improvement in angina severity by at least one CCS class. A total of 45% of patients reported freedom from limiting angina and improvements of two or more grades in their CCS class.
Benefits were also noted in a significant reduction in the mean number of anti-ischemic drugs used.
“The publication is another ‘real-world,’ non-randomized study which demonstrates clinical results in an additional 141 enrolled patients, that are remarkably consistent with the results of the COSIRA randomized sham-controlled clinical trial. This recent manuscript published in the International Journal of Cardiology is a testament to the benefits of the Reducer as a safe device, which can provide substantial qualify of life improvements in patients with refractory angina, who do not have other suitable treatment alternatives. We are very pleased to have this data published in such a highly-regarded journal,” prez & CEO Fred Colen said in a press release.
In June, Neovasc said its Reducer device was used in its first procedure in the US.