Announcing the implantable pump for delivery of Remodulin®

Our company has been dedicated to the treatment of PAH since it was founded in 1996 by the parents of a child diagnosed with PAH. We received FDA approval in July 2018 for the Implantable System for Remodulin® (ISR).1 The approval of this implantable pump represents an implantable approach to managing patients with PAH and has been something that patients using Remodulin have long awaited.

The FDA approval is the first step in making the pump available to patients. We anticipate that the first patients will undergo the ISR implant procedure in the beginning of 2019 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.