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Implantable System

Implantable system for Remodulin
Implantable system for Remodulin
Implantable system for Remodulin with Medtronic
Holding implantable system for Remodulin

IN DEVELOPMENT—The Implantable System for Remodulin*

Implantable System for Remodulin (ISR) offers a fully implantable unit with no external pump or tubing

  • Frees you from daily pump management and the hassles of wearing a pump

Update on ISR Availability, December 2019

In 1996, United Therapeutics set out to change the future for people impacted by PAH. More than 20 years later, we remain committed to developing innovative treatments that aim to improve the lives of PAH patients, including the joint development of the Implantable System for Remodulin with Medtronic.

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.

PMA=premarket approval.

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Remodulin® (treprostinil) Injection

Important Safety Information for Remodulin

Before you take Remodulin, tell your healthcare provider if you:

What are the serious side effects of Remodulin?

What are the possible side effects of Remodulin?

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive.

What is Remodulin?

Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. It is not known if Remodulin is safe and effective in children.

In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms.

REMISIconOct19

To learn more about Remodulin, talk with your healthcare provider. Please see Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

PAH=pulmonary arterial hypertension; WHO=World Health Organization.

Remodulin® (treprostinil) Injection

Important Safety Information for Remodulin

Before you take Remodulin, tell your healthcare provider if you:

What are the serious side effects of Remodulin?

What are the possible side effects of Remodulin?

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive.

What is Remodulin?

Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. It is not known if Remodulin is safe and effective in children.

In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms.

REMISIconOct19

To learn more about Remodulin, talk with your healthcare provider. Please see Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

PAH=pulmonary arterial hypertension; WHO=World Health Organization.