PMA application for XPS™ with STEEN Solution™ submitted to the FDA
XVIVO Perfusion has submitted the PMA (Premarket Approval) application for the XPS™ with STEEN Solution™ to the FDA. The NOVEL Extension Clinical trial, that completed enrollment in 2017 constitutes the basis of the company’s PMA application.Lung transplantation remains a last treatment option for patients with end stage lung disease. Unfortunately, the lung is one of the least transplanted organs, leaving many patients with end stage lung disease to die without ever receiving a lung transplant. In 2016, 2322 patients received lung transplants in the US, 136 patients were removed from the