The European Society of Cardiology Includes Neovasc Reducer™ for the Treatment of Refractory Angina in the European Practice Guidelines for the Diagnosis and Management of Chronic Coronary Syndromes.
Announcement Made at ESC Congress 2019 in Paris, France
3 September 2019
The Neovasc Reducer™ (the “Reducer”), interventional device for the treatment of patients suffering from refractory angina, has been added to the new 2019 European Society of Cardiology (ESC) Practice Guidelines. The ESC now recommends that the Reducer might be considered for the treatment of patients with angina refractory to medical and interventional therapies. The announcement was made at the ESC Congress 2019 in Paris, France.
Importantly, the Reducer was the only non-pharmaceutical treatment included in the “Major New Recommendations” section of the 2019 ESC Guidelines. In addition, the Reducer enters the ESC Guidelines at the highest recommendation class for therapies addressing refractory angina, a condition that is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.1
ESC Guidelines summarize and evaluate all available scientific evidence with the aim of assisting physicians in selecting the best evidence-based therapies and management strategies for an individual patient with a given condition. This set of recommendations takes into account the impact on outcomes, as well as the risk-benefit ratio of a particular diagnosis or therapy, as reflected in the available scientific data. ESC Guidelines represent the ofﬁcial position of the European Society of Cardiology on a given topic and are regularly updated.
“We are honored that our Reducer has been added to the Guidelines of the ESC, one of the most prestigious and influential cardiology-related organizations in the world,” said Professor Shmuel Banai, M.D., Medical Director of Neovasc. “The addition of the Reducer to the ESC Guidelines is a reflection of the substantial amount of high-quality clinical evidence published to date in scientific medical literature supporting the safety and efficacy of the Reducer in treating refractory angina and improving quality of life for patients. We are also pleased with the significant place that microvascular angina is taking in the ESC Guidelines and believe that this is indicative of the unmet need for patients suffering from angina without obstructive coronary artery disease.”
Fred Colen, CEO of Neovasc, said: “This ESC recommendation is an important step towards the establishment of the Reducer as a standard of care for the treatment of patients with refractory angina.”
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, there by 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 FDA 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.
About Neovasc Inc.
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,
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.