The Reducer system is designed to alter blood flow in the heart’s circulatory system to increase perfusion of oxygenated blood to ischemic areas of heart muscle, and can be placed in a minimally invasive transvenous procedure, Neovasc said.
The German body gave the device Nub status 1 designation for 2018, the highest priority designation available, up from a previously set Nub 4 status, the Vancouver-based company said.
The designation is valid for one year and can be renewed annually, and allows for negotiations between hospitals and health insurance groups for reimbursements of new medical treatments in the country.
With the new designation, a total of 107 German hospitals can now arrange for reimbursement coverage for the reducer therapy, Neovasc said.
“This significant upgrade to the highest level in the German NUB status is an exciting development for the Reducer therapy in Europe. For many patients Angina remains a significant issue and many of them have limited treatment options today. This positive NUB development will allow additional patients suffering from refractory angina to be treated with the Reducer in Germany,” Neovasc CEO Fred Colen said in a prepared statement.
Last month, Neovasc said it saw low leak rates in the clinical program for its Tiara mitral valve replacement and a 30-day all-cause mortality rate of nearly 10%.