ARVIK HEART, Inc.,
a privately-held company that develops and manufactures cardiac assist devices,
announced conditional FDA approval of its Pivotal Trial for evaluation of the
Jarvik 2000® heart for destination therapy (DT).
Use of the device for DT means that it will provide long-term,
permanent support to end-stage congestive heart failure patients who are not
candidates for heart transplant. The approval permits fifty medical centers to
participate in the study. Each medical center may begin enrolling patients
immediately upon approval by their Institutional Review Board.
Prior to full FDA approval of the trial, the company must submit
additional information concerning statistical analysis and conduct of the
study, as well as some additional engineering data.
The trial will randomize up to 350 study subjects to either the
treatment group, in which patients receive the Jarvik 2000 intraventricular
heart assist device, or the control group, in which patients receive the
HeartMate® II left ventricular assist device (LVAD), the most widely used
FDA-approved LVAD for DT. Patients will be followed for two years to assess
primary endpoint success, generally defined as survival free of disabling
complications. If the data analysis at two years, or at a prior interim
analysis, establishes non-inferiority of the Jarvik 2000 compared to the
control, the trial will be judged successful. Additionally, the patients will
be followed for another year and the rates of serious infection related to the
power cable and pump pocket will be analyzed for the three years since implant.
Regarding device-related infection, the analysis is designed to determine if
the Jarvik 2000 that uses a unique behind-the-ear power cable and has no pump
pocket is superior to the HeartMate II, which uses an abdominal cable and has
an abdominal pump pocket.
The Jarvik 2000 has been used to treat late-stage heart failure in more
than 500 patients in the United States, Europe, and Asia. The Jarvik 2000 model
with the behind-the-ear connector has supported more than 200 patients in
Europe for DT, including the longest survival of any heart assist device
patient in the world, 7 1/2 years.
The bridge-to-transplant model of the Jarvik 2000 has a power cable
that exits the abdominal wall—the same position used with the HeartMate II and
HeartWare® VADs. The behind-the-ear cable, which will be used in this study,
may have significant quality-of-life advantages over abdominal cables. It
requires practically no care of the cable exit site and, unlike abdominal
cables, does not require frequent redressing with sterile bandages that may
require expensive home nursing. Jarvik 2000 patients with the behind-the-ear
connector may shower and bathe normally and can even go swimming. In Europe,
these patients have had low rates of infection, and there have been no failures
of the internal cables and no mechanical failures of the Jarvik 2000 blood pump
or its bearings. Long-term bench durability tests project high reliability of
the device for ten years or more.
JARVIK HEART has also completed enrollment of the primary cohort of 150
patients in the US Bridge-to-Transplant Pivotal Study and is nearing completion
of the follow-up period. Only two patients have yet to reach outcome. The results in the study patients who
received the most recent Jarvik 2000 model, using patented cone bearings, are
expected to show a substantial improvement in the primary endpoint compared to
the pin bearing design used earlier in the BTT study. Only cone bearings will
be used in the DT trial.
JARVIK HEART is continuing research on new developments including child
size and tiny infant size pumps with the support of the National Institutes of
Health under the "PumpKIN" program (Pumps for Kids, Infants, and
Neonates).
SOURCE JARVIK HEART, Inc.
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