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, the Vancouver-based company said.
“We are pleased to provide this patient the opportunity to receive a Reducer implanted under Compassionate Use. As our studies and patients in multiple geographies, including Europe, Israel and Saudi Arabia, have shown, this device offers angina sufferers the potential to improve exercise capacity and resume a normal life, free of the pain and discomfort that has often limited their ability to perform normal daily activities. The Reducer continues to gain attention from medical professionals around the world as the number of patient cases have increased with the scaling of our commercial activities,” prez & CEO Fred Colen said in a press release.
The device was implanted in an FDA-approved compassionate use case by Dr. Gerald Koenig, Dr. Ryan Gindi and colleagues at Detroit’s Henry Ford Hospital, Neovasc said.
“This patient has severe coronary artery disease and has suffered from refractory angina for a few years. The condition has had a significant impact on his quality of life during this time, with little to no relief from multiple other widely accepted treatment options. This novel device has accumulating evidence supporting the physiological basis and associated clinical benefit. My experience with the Reducer during the procedure, was very positive. The process is similar to implanting a stent. In terms of the patient, he tolerated the procedure very well and had no complications,” Dr. Koenig said in a prepared statement.
In February, Neovasc said it won reimbursement coverage from the German Institute for the Hospital Renumberation System for its Reducer device designed to treat refractory angina.