IN DEVELOPMENT: The Implantable System for Remodulin (ISR)
Give your patients the freedom of life without an external pump.
The revolutionary ISR will provide continuous delivery of Remodulin from a pump implanted in the patient’s abdomen through a surgical procedure. The use of ISR can remove the risk of bloodstream infection from the central line and eliminate infusion site pain.
Who are the best candidates for an implantable pump?
- FC II and III patients who are on a stable dose of Remodulin
- Patients healthy enough to undergo surgery
To become eligible, patients currently on Flolan® (epoprostenol sodium) must transition to a stable dose of IV Remodulin before transitioning to ISR.
News Update: December 2019
Our initial expectation was to launch ISR at the PAH centers involved in the clinical trial with broader expansion of the program throughout 2020. Based on recent communications from the FDA, Medtronic will not be able to satisfy conditions to its premarket approval in 2020. As a result, we now estimate initial implantations will occur in 2021.
The collaboration between United Therapeutics and Medtronic remains strong and both companies look forward to the launch of the ISR.
For Important Safety Information on ISR, please click here.
FDA requires that certain conditions of Medtronic’s PMA approval of the Implantable System for Remodulin must be satisfied prior to launch or sale of the Implantable System for Remodulin; accordingly, Implantable System for Remodulin labeling may be revised in the process of satisfying such conditions of approval.
Talk to your United Therapeutics Representative for more information about how you could become a provider for the Implantable System for Remodulin.
FC=functional class; IV=intravenous; PAH=pulmonary arterial hypertension; PMA=premarket approval.