This week we learned that the much-awaited arrival of the Implanted Pump System for Remodulin would be further delayed. The FDA did not grant Medtronic and United Therapeutics approval. Details are scant but the announcement indicated that the device might be approved in the beginning of 2018.
PAH Patients and doctors alike were let down by the delay. The delay does not mean that the device will not get approved. My advice is to remain positive and continue on your existing therapies. We remain optimistic that in the not-to-distant future we will be able to deliver the benefits of Remodulin without site pain or external catheters.
