Pulmonary arterial hypertension (PAH) is a severe, chronic syndrome affecting the small
pulmonary arteries (blood vessels which carry blood from the heart to the lungs to pick up
oxygen). At the time of the initiation of this study, no cure exists for this disease.
Medtronic has developed a fully implantable, long term, intravenous infusion system, which
has the potential to enhance patient convenience and ease of use, while reducing the
opportunities for catheter-related infections and complication issues associated with
currently used external delivery systems. The information gained from this study could
provide evidence to support use on an implantable infusion system for the management of other
disease states requiring chronic intravenous therapy. Additionally, information collected
from this study may contribute to the design of new product(s)/therapy(ies) and/or
instructions for use.
The purpose of this clinical study is to evaluate the safety profile of the Model 10642
Implantable Intravascular Catheter portion of the PAH Implantable Vasodilator Therapy (PIVoT)
system. This study will focus on the safety of delivery of Remodulin Injection in the
treatment of patients with PAH who meet the approved Remodulin Injection indication, using
the approved formulation, and approved intravenous route of administration.
The Model 10642 Implantable Intravascular Catheter being used in this study is
investigational, meaning it has not been approved by the FDA to be safe. The Model 10642
Catheter is different from other commercially available drug delivery catheters because the
Model 10642 Catheter tube has a one-way valve designed to allow the medication to flow out
but keep blood from flowing back into the catheter tube. The Model 10642 Catheter is
reinforced to prevent kinking and crushing, which could interrupt the flow of medication.
Remodulin Injection is a Food and Drug Administration (FDA) approved drug for the intravenous
and subcutaneous treatment of PAH.
The SynchroMed II Implantable Infusion System is approved by the FDA to deliver specific
drugs in patients who have chronic pain, need management of severe spasticity, and for cancer
treatment but has not been approved to deliver Remodulin Injection in patients with PAH.
There is also a Catheter Imaging Sub-Study that is being done to measure the shape change of
the Model 10642 Implantable Intravascular Catheter during a given set of patient positions
through the use of x-ray imaging. This data will help us develop more clinically realistic
bench tests and simulations that better mimic the challenges experienced by an implanted
catheter. This Catheter Imaging Sub-Study will be conducted at up to seven centers and will
enroll up to forty patients that are currently enrolled in the DelIVery for PAH clinical
study and are at least three months post-implant of their current catheter and pump.
