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.
