Thoratec's joy at LVAD (left ventricular assist device) decision muted by FDA conditions
This article was originally published in Clinica
Executive Summary
Thousands of people in the US who face death each year from congestive heart failure (CHF) could soon have a new treatment at hand, after an FDA advisory panel voted in favour of expanding the use of Thoratec's heart pump for long-term therapy. However, despite Thoratec's delight at the panel's verdict, issues raised by some of the FDA advisors look to have given the company cause for concern.