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ISR

Implantable System for Remodulin (ISR)

The Implantable System for Remodulin (ISR)

After 12 years of collaboration, Medtronic and United Therapeutics have decided to terminate the development of the Implantable System for Remodulin (ISR). This decision is based on the evolution of treatment options and paradigms for PAH patients over the past few years, coupled with the anticipated efforts required to satisfy the FDA’s conditions to its approval of the ISR.

"United Therapeutics shares the disappointment felt by so many PAH patients and physicians regarding the discontinuation of the ISR program. We remain committed, however, to bringing new therapies and technologies to patients in the near-term that will improve the management of PAH. We are also committed to continuing to support those patients from the clinical study that are currently using the ISR. Thank you to all of the health care providers, patients and families who have been involved in the ISR program for the last 12 years."
– Michael Benkowitz, President and Chief Operating Officer

FDA = Food and Drug Administration; PAH = pulmonary arterial hypertension.

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).