The New Drug Application (NDA) for the use of Remodulin (treprostinil; United Therapeutics) Injection in the Implantable System for Remodulin (ISR; Medtronic) has been approved by the Food and Drug Administration (FDA).
Remodulin, a prostacyclin vasodilator, is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1), to diminish symptoms associated with exercise, or for patients requiring transition from Flolan (epoprostenol sodium; GlaxoSmithKline), to diminish the rate of clinical deterioration. The product was originally approved for administration by continuous subcutaneous and intravenous routes using external pumps.
The newly approved ISR is indicated for adult patients with Class I, II, and III PAH receiving intravenous delivery of Remodulin and is composed of the Medtronic SynchroMed II implantable drug infusion pump and a newly developed intravascular catheter. Approval of the ISR was based on results from the DellVery for PAH trial which involved 64 participants, of which 60 were successfully implanted. The study showed that the new delivery system effectively delivered Remodulin and was associated with a low rate of catheter-related complications. Complications were defined as events that required an invasive intervention.
“External infusion pumps have been used to deliver prostacyclins for PAH, but managing the therapy places a significant burden on patients, interferes with their daily activities, and runs a high risk of infections,” said David Steinhaus, MD, Cardiac and Vascular Group at Medtronic. “This fully implantable drug delivery system was designed to address these serious patient care concerns.”
For more information visit Medtronic.com.