Neovasc, a speciality medical device company, has announced that it seeking FDA's designation for Neovasc Reducer as a Humanitarian Use Device (HUD) for the treatment of refractory angina.
Image: the Reducer has secured CE-marked in the European Union and Breakthrough Device designation from FDA . Photo: Courtesy of Ignacio D. G. from Pixabay
Neovasc is engaged in the development of minimally invasive transcatheter mitral valve replacement technologies and minimally invasive devices for the treatment of refractory angina.
Refractory angina is a painful condition caused due to inadequate supply of blood delivered to the heart muscle from the coronary arteries, despite treatment with standard revascularization or cardiac drug therapies.
Following recently received FDA guidance, the company is planning to secure the FDA’s ‘HUD for CCS Class IV refractory angina patients’ designation for its Reducer.
It is expected to start commercialising the Reducer in the US by early 2020, subject to the FDA approval for HUD designation, along with FDA approval of subsequent HDE application.
Neovasc CEO Fred Colen said: “Should the FDA grant the Class IV HUD designation to the Reducer, we expect to be in a position to offer treatment to those patients with CCS Class IV refractory angina in early 2020. We view this as a significant market opportunity for Neovasc.
“Concurrently, we will explore an alternate investigational device exemption clinical study design, in conjunction with our supportive U.S. cardiologists, with the intent of further expanding the patient population to CCS Class III patients and to seek full approval for the CCS Class IV patients over time.”
Neovasc said that the Reducer has secured CE-marked in the European Union and Breakthrough Device designation from FDA for the treatment of refractory angina.
In addition, its Reducer alters blood flow in the heart’s circulatory system, and increases the perfusion of oxygenated blood to ischemic areas of the heart muscle to provide relief from angina symptoms.
The Reducer is placed using a minimally invasive transvenous procedure similar to implanting a coronary stent, and usually takes approximately 20 minutes for completion.
Neovasc stated:“The maximum total U.S. annual addressable market with a Reducer HDE under a CCS Class IV would be limited, by statute, to a maximum number of patients per year in the U.S. with the most severe refractory angina, and is therefore limited to an estimated US$80 million of potential revenue per year.”