United Therapeutics has been closely monitoring the rapidly evolving situation around Coronavirus (COVID-19). We are dedicated to providing ongoing support for patients and healthcare providers, and ensuring an uninterrupted supply of drug product.

ISR

Implantable System for Remodulin (ISR)

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.

ISR availability

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.

Learn how to best transition your patients from Flolan.

FC=functional class; IV=intravenous; PAH=pulmonary arterial hypertension; PMA=premarket approval.

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line at 1-877-UNITHER (1-877-864-8437).

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line at 1-877-UNITHER (1-877-864-8437).