Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that European Heart Journal – Case Reports has published an article titled, “Implantation of the Coronary Sinus Reducer for Refractory Angina due to Coronary Microvascular Dysfunction in the Context of Apical Hypertrophic Cardiomyopathy – a Case Report.” The article is authored by Dr. Kevin Cheng, et al, at the National Heart and Lung Institute Imperial College London, Royal Brompton Hospital, London.
The report details the case of a 42-year-old female suffering from a history of daily angina chest pain. Despite previous coronary stent implantation procedures, her pain was debilitating and frequent. She was taking multiple medications to help address her angina, yet experienced angina pain two to five times per day, with episodes lasting from ten minutes to two hours. A diagnostic angiogram revealed her coronary arteries were not obstructed and blood supply to her heart was normal. The previously placed stents were patent, but her chest pain persisted. The patient was diagnosed with microvascular dysfunction, a disease affecting the small vessels in the heart that disproportionately effects women. She underwent implantation of a Neovasc ReducerTM (“Reducer”, CE Marked and under US IDE investigation) at the Royal Brompton Hospital under the supervision of Dr. Ranil de Silva.
A Positron Emission Tomography (“PET”) scan was performed before, and six months after the Reducer procedure. The initial PET scan revealed that a portion of her heart muscle was not receiving sufficient blood flow, likely causing her chest pain. The follow-up PET scan, after Reducer implantation, revealed that the area of her heart muscle that previously was not receiving adequate blood flow had improved, correlating with a substantial improvement in her symptoms and quality of life. The follow-up PET scan also documented that blood supply to her heart muscle was normalized, away from areas with more than sufficient blood supply (non-ischemic regions) to the under-supplied, ischemic regions.
“It’s extremely gratifying to see patients long-suffering from refractory angina, most of whom have exhausted conventional treatment options, feeling better and improving their quality of life,” stated Dr. de Silva. “Microvascular dysfunction is an important and frequently under-recognised cause of angina, with patients frequently experiencing life-limiting symptoms for years before their condition is diagnosed and treated. At the Royal Brompton Hospital, we focus on the management of these patients and are very pleased to provide a treatment that offers hope for appropriately selected patients suffering from the debilitating symptoms associated with this condition.” He added, “Cases such as these have motivated us to undertake the REMEDY-PILOT trial, funded by the British Heart Foundation, which will evaluate the effects of the coronary sinus Reducer in patients with coronary microvascular dysfunction.”
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 within the myocardium of the heart and 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.
While the Reducer is not approved for commercial use in the United States, it is being studied in the COSIRA-II Clinical Trial, and the FDA granted Breakthrough Device designation to the Reducer in October 2018. Breakthrough 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 of 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.
