Medtronic receives FDA approval for implantable system for Remodulin® to treat patients with pulmonary arterial hypertension

In a recent press release, Medtronic announced that it has received U.S. Food and Drug Administration (FDA) approval for the Implantable System for Remodulin® (ISR) to treat patients with pulmonary arterial hypertension (PAH).

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 Through a first-of-its-kind collaboration, the Medtronic SynchroMed(TM) II drug delivery system and cardiac catheter technologies were leveraged to deliver the PAH medication Remodulin® (treprostinil) Injection developed by United Therapeutics Corporation (NASDAQ:UTHR). United Therapeutics will lead the commercial promotion of the ISR, with Medtronic support.

PAH is a severely debilitating and progressive disease that causes high blood pressure in the pulmonary arteries, ultimately resulting in right-heart failure and premature death. It predominantly affects women, who are typically diagnosed in their late 30s to early 50s.1,2,3

1Thenappan T, Shah SJ, Rich S, Gomberg-Maitland M. A USA-based registry for pulmonary arterial hypertension: 1982-2006. Eur Respir J. 2007;30:1103-10

2Humbert M. Update in pulmonary arterial hypertension. 2007. Am J Respir Crit Care Med. 2008;177:574-9

3Runo JR, Loyd JE. Primary pulmonary hypertension. Lancet. 2003;361(9368):1533-44.

Editor’s note: this blog post originally appeared on Medtronic’s website.

To view the full press release, please click here. 

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Through a first-of-its-kind collaboration, the Medtronic SynchroMed(TM) II drug delivery system and cardiac catheter technologies were leveraged to deliver the PAH medication Remodulin® (treprostinil) Injection developed by United Therapeutics Corporation (NASDAQ:UTHR). United Therapeutics will lead the commercial promotion of the ISR, with Medtronic support.

PAH is a severely debilitating and progressive disease that causes high blood pressure in the pulmonary arteries, ultimately resulting in right-heart failure and premature death. It predominantly affects women, who are typically diagnosed in their late 30s to early 50s.1,2,3

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