United Therapeutics Corporation announced July 31 that it had received approval from the Food and Drug Administration (FDA) for Remodulin® (treprostinil) to be used in the Implantable System for Remodulin® for patients with WHO Group 1 PH (pulmonary arterial hypertension, or PAH).
Development of the Implantable System for Remodulin® resulted from a collaboration between United Therapeutics and Medtronic. The Implantable System for Remodulin® includes the Medtronic SynchroMed™ II pump, a catheter developed by Medtronic for delivering treprostinil from the implantable pump (model 10642 Implantable Intravascular Catheter) and the drug manufactured by United Therapeutics, treprostinil. Medtronic received FDA approval for the Implantable System for Remodulin® (SynchroMed™ II pump and intravascular catheter) in December 2017.
The Implantable System for Remodulin® is approved for adults with PAH, with New York Heart Association/World Health Organization (NYHA/WHO) Functional Class I, II and III PH, who are receiving IV treprostinil therapy. The system was tested in the DelIVery for Pulmonary Arterial Hypertension clinical trial, with results published in CHEST Journal in July 2016. In this trial, 60 PAH patients who were receiving a stable dose of IV treprostinil for at least four weeks received the Implantable System for Remodulin® and were followed for approximately one year. Also in this trial, researchers examined how safe the system was, assessing how frequently patients on the system had catheter-related complications. The study reported that six catheter-related complications occurred, for a complication rate of 0.27 per 1,000 patient-days; this is better than what the study was seeking to show, which was a complication rate of 2.5 per 1,000 patient-days. On average, they estimated that patients spent approximately 2.5 hours per week managing their IV treprostinil before the study. With the Implantable System for Remodulin®, they estimated that this time decreased to about 35 minutes per week.
The DelIVery clinical trial continues to follow enrolled patients to ensure that the implantable pump delivers medication as programmed.
Patients on the Implantable System for Remodulin® will need to have the pump refilled by a health care professional approximately every 12-16 weeks, depending on the dose of the medication.
Having received FDA approval, the companies will be working on a full plan to make the system available for patients.