United Therapeutics Corporation has notified the Pulmonary Hypertension Association (PHA) that there will be a delay in distribution of the Implantable System for Remodulin® (ISR), a collaboration between United Therapeutics Corporation and Medtronic, which was approved by the Food and Drug Administration (FDA) late last year. The ISR is approved for adults with functional class I, II and III pulmonary arterial hypertension (PAH) who are receiving intravenous (IV) treprostinil therapy. In October, United Therapeutics and Medtronic announced that they expected to begin broad distribution of a new ISR in late 2019, but that date is now expected to be in early 2020.
United Therapeutics shared the following statement with PHA about the availability of the ISR:
“United Therapeutics Corporation’s initial expectation was to launch ISR at the PAH centers where the clinical study was conducted, with broader expansion of the program in the latter part of 2019. However, FDA has requested additional information related to their review and approval of ISR. Due to these requests we are now estimating initial implantations will occur in early 2020. Additionally, the limited supply issue that we were anticipating has been resolved and we expect to have enough pumps to ensure that current IV Remodulin patients who want a pump will have one available.”