Neovasc Inc (NASDAQ:NVCN) says that it has submitted its Premarket Approval application (“PMA”). It now awaits to see the decision the U.S. Food and Drug Administration (“FDA”) makes regarding its Neovasc Reducer™ (“Reducer”) medical device. This is set to be a helpful device that will help in handling a severe condition known as refractory angina. Along with this submission, the company has also filed for a request to hold an Advisory Panel meeting.
The severity of refractory angina
The Chief Executive Officer of Neovasc, who also happens to be its President Fred Colen, has spoken concerning the recent developments. The official says that the submission marks a major milestone for them as they work towards serving the UIS marker with the Reducer. From the estimates, about 1.8 million patients in the country have been struggling with refractory angina.
Traditionally, these patients lacked suitable options. It was either revascularization worked for them, or they would go on suffering! Many affected persons admit how much they had to suffer from the condition after having undergone revascularization procedures.
Experts say that the Reducer is a step towards wellness, considering that it will help provide relief to the various angina symptoms. This will probably be by the alteration of blood flow in the heart’s myocardium. This will translate into increased perfusion of oxygenated blood to all the ischemic segments of the heart muscles.
The Reducer and what it portends for the future
The PMA for Reducer covers a sham-controlled trial, a double-blind, and the COSIRA 104 patient randomized. This is not forgetting the ongoing REDUCER-I European Post-Market study, which, according to sources, consists of almost 200 patients. All of them have enrolled for a 5-year plan that includes follow up supportive action from the peer-reviewed publications in line with the Reducer.
The European Union sees the Reducer as the solution the world needs in line with dealing with this condition called refractory angina. It is rather painful and debilitating at the same time and usually occurs at that point when the coronary arteries are unable to channel enough blood to the heart muscle. It, at times, gets impossible even after a patient resorting to the cardiac drug therapies or the standard revascularization.
