BackgroundThe DelIVery for Pulmonary Arterial Hypertension clinical trial was a
multi-center, prospective, single arm, Investigational Device Exemption
study utilizing a fully implantable, programmable intravascular delivery
system consisting of a pump and a catheter for intravenous treprostinil. The
study met its primary endpoint and demonstrated that the intravascular
delivery system significantly reduced catheter related complications at
22,000 subject-days of follow-up compared with a predefined objective
performance criterion. Here we summarize the results obtained during a
6.4-year follow-up period.MethodsThroughout study follow-up, participants had clinic visits and medication
refills at least every 12 weeks (dependent on the subjects’ dose). All
adverse events and intravascular delivery system complications were
evaluated and recorded.ResultsSixty pulmonary arterial hypertension subjects were followed post device
implantation for approximately 282 patient-years (range 87 days to 6.4
years). Of the 60 subjects, 14 died (1 related to intravascular delivery
system pump failure), 2 withdrew after lung transplants, and 2 withdrew due
to pump pocket infection. No catheter-related bloodstream infections,
catheter thrombosis or occlusions, or catheter kinks occurred through 282
patient-years. Two participants had adverse events of abdominal pain, rash,
due to subcutaneous treprostinil “leaks” after one catheter puncture and one
catheter laceration during pump refill and replacement, respectively. Eight
pump failure events occurred: seven pump motor stalls and one early
replacement (faulty battery).ConclusionDelivery of treprostinil with an intravascular delivery system is a safe
alternative to an external delivery system, while providing enhanced life
experiences. To preserve the risk–benefit ratio, treatment at specialized
pulmonary arterial hypertension centers is recommended until training is
disseminated at other sites.
The Model 10642 vascular catheter along with the SynchroMed II implantable drug delivery system showed promising performance in a chronic animal model.
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