HeartWare granted FDA approval to begin U.S. clinical trials for LVAS
HeartWare has received conditional approval from the FDA of an Investigational Device Exemption (IDE) for its lead product, the HeartWare left ventricular assist system (LVAS).
Since the FDA granted conditional IDE approval, the Sydney, Australia-based company is now allowed to immediately commence its U.S. clinical trial for the HeartWare LVAS for use as a bridge-to-transplant in patients suffering from end-stage heart failure.
“As previously indicated, we expect to be able to charge for our system during the course of our U.S. clinical trial, said Doug Godshall, CEO and president of HeartWare. “We expect to supplement this revenue through commercial sales in Europe once we receive CE Mark [approval] later this year.”
Since the FDA granted conditional IDE approval, the Sydney, Australia-based company is now allowed to immediately commence its U.S. clinical trial for the HeartWare LVAS for use as a bridge-to-transplant in patients suffering from end-stage heart failure.
“As previously indicated, we expect to be able to charge for our system during the course of our U.S. clinical trial, said Doug Godshall, CEO and president of HeartWare. “We expect to supplement this revenue through commercial sales in Europe once we receive CE Mark [approval] later this year.”