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HeartWare
International, Inc.
, a leading innovator of less
invasive, miniaturized circulatory support technologies that are
revolutionizing the treatment of advanced heart failure, today announced that
the U.S. Food and Drug Administration (FDA) has approved an IDE
(Investigational Device Exemption) Supplement that allows HeartWare to
commence enrollment in an additional patient cohort for ENDURANCE, the
Company's pivotal, Destination Therapy clinical study.
In this supplemental cohort, HeartWare will enroll up to 286 patients
receiving the HeartWare^® Ventricular Assist System, as well as up to an
additional 143 control patients using a randomization scheme consistent with
the ENDURANCE protocol. Patients will be followed for 12 months after
implant. HeartWare intends to incorporate the data from both this new cohort
and ENDURANCE into an anticipated Pre-Market Approval (PMA) Application
seeking approval of the HeartWare System for the Destination Therapy
indication.
The protocol for this cohort is designed to confirm clinical observations that
sites adhering to more regular monitoring and management of patient blood
pressure witnessed a notably lower incidence of neurological events.
Patient enrollment can commence at the 50 centers participating in the
ENDURANCE clinical trial, following Institutional Review Board approvals at
each of the centers.
On November 20, 2012, FDA granted approval of the HeartWare System for the
Bridge-to-Transplant indication. Concurrent with approval, the Company
commenced a post-approval study (PAS) to assess device performance in a
real-world setting. HeartWare's PAS is a registry consisting of 600 patients
who receive an HVAD and an additional 600 control patients derived from a
contemporaneous group of continuous flow, intra-corporeal LVAD patients
entered into the INTERMACS database. HeartWare expects enrollment for both
arms of the PAS will be complete by year's end.
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