The Food and Drug Administration (FDA) recently approved the Implantable System for Remodulin® (ISR), a collaboration between United Therapeutics Corporation and Medtronic. The ISR is approved for adults with functional class I, II and III pulmonary arterial hypertension (PAH) who are receiving intravenous (IV) treprostinil therapy. There are a very limited number of ISRs currently available. United Therapeutics and Medtronic expect to begin broad distribution of a new generation of implantable device in late 2019.
United Therapeutics shared the following statement with PHA about the availability of the ISR:
United Therapeutics has been dedicated to the treatment of PAH since the company was founded. We recently received FDA approval for the Implantable System for Remodulin® (ISR). The approval of this implantable pump has been something that patients using Remodulin have long awaited.
The FDA approval is the first step in making the pump available to patients. There are multiple steps to make sure that doctors and patients have all the necessary information and resources for successful implantations. We expect the first patients to undergo the ISR implant procedure in the beginning of 2019 and then additional procedures will be scheduled at PAH centers where the clinical studies were conducted. There is a limited supply of pumps available initially and we plan to begin a broader expansion of the program in the latter part of 2019.