Overview of the virtual 2020 FDA's circulatory system devices advisory panel on Neovasc reducer system

Abstract

Refractory angina is considered a devastating condition with limited medical and therapeutic options. The Neovasc Reducer device, when implanted in the coronary sinus, is designed to alleviate anginal symptoms. However, the available clinical data are sparse. The US Food and Drug Administration (FDA) assembled the Circulatory Systems Devices Panel to discuss the Reducer's safety and effectiveness. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we detail the deliberation and discussion among the circulatory panel members, including their final vote. K E Y W O R D S coronary artery disease, interventional devices/innovation, new devices (in general) 1 | INTRODUCTION On October 27, 2020, the United States (US) Food and Drug Administration (FDA) convened the first ever virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee during the coronavirus disease 2019 pandemic, to consider a de novo premarket approval application for the Neovasc Reducer System (Neovasc, Richmond, Canada). | THE NEOVASC REDUCER SYSTEM | Reducer device designThe physiological concept of the reducer device was based on key aspects of the surgical Beck procedure, first described in 1954, in which the coronary sinus (CS) is surgically narrowed to 3 mm to improve collateral blood flow to ischemic myocardium. 1 Initial success of the procedure was most likely driven by elevated CS pressure, which led to improved perfusion of ischemic territories. This resulted in complete resolution of symptoms in most patients. 2 The Neovasc Reducer System is a stainless steel, hourglass-shaped, implantable reducer device, pre-mounted on a balloon catheter for implantation in the CS (Figure 1). It is made in a single device size, designed to fit a range of anatomies (compatible with CS diameters of 9.5-13 mm) with inflation of a semi-compliant balloon. The delivery catheter is inserted through a puncture in the internal jugular vein through the right atrium and into the CS. The reducer device is implanted 2-4 cm distal to the ostium of CS. This reducer device is designed to establish a narrowing in the CS, which is believed to result in an increase in back pressure. Therefore, the reducer's proposed mechanism would redistribute blood flow from non-ischemic territories of myocardium to improve perfusion to ischemic myocardium in the presence of reversible ischemia. 32.2 | Breakthrough device designation Refractory angina is a common problem faced in cardiology, afflicting nearly 2 million patients in the US. 4 Many patients with coronary artery disease who are not candidates for revascularization have refractory angina despite efforts to control symptoms with medical therapy, leaving an unmet need. Neovasc requested and received the first breakthrough device designation under the Breakthrough Devices Program (Section 515B of the federal Food, Drug, and Cosmetic Act