Medtronic has secured approval from the US Food and Drug Administration (FDA) for the use of the Implantable System for Remodulin (ISR) to treat pulmonary arterial hypertension (PAH) patients.
ISR utilises Medtronic’s SynchroMed II drug delivery system and cardiac catheter technologies to deliver the Remodulin (treprostinil) Injection.
Remodulin is a PAH medicine developed by biotechnology company United Therapeutics, which will be responsible for ISR’s commercial promotion with support from Medtronic.
SynchroMed II is an implantable drug infusion pump that together with a new intravascular catheter will intravenously deliver Remodulin to patients who were previously administered the drug through an external infusion pump.
The regulatory filings for the device and drug were submitted by Medtronic and United Therapeutics, respectively.
Medtronic Cardiac and Vascular Group, Heart Failure business general manager David Steinhaus said: “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.
“This fully implantable drug delivery system was designed to address these serious patient care concerns.”
The FDA decision comes after a review of data from the prospective, single-arm, non-randomised, open-label DelIVery clinical trial performed in 64 subjects at ten US sites.
Of the total participants, 60 were successfully implanted in the trial, during which the implantable intravascular delivery system is said to have demonstrated the ability to effectively deliver treprostinil.
The ISR system is reported to have yielded a low catheter-related complications rate and increased patient satisfaction.