Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Implantable System for Remodulin (ISR) to treat patients with pulmonary arterial hypertension (PAH).
Via first-of-its-kind partnership, the Medtronic SynchroMed II drug delivery system and cardiac catheter technologies have been were leveraged to deliver PAH medication Remodulin (treprostinil) injection developed by United Therapeutics.
The system consists of Medtronic SynchroMed II implantable drug infusion pump and newly developed intravascular catheter to deliver Remodulin intravenously to patients who have earlier been securing Remodulin intravenously through an external infusion pump.
FDA approval was based on prospective, single-arm, non-randomized and open-label DelIVery for PAH trial, which was carried out at 10 sites in the US.
The study, which recruited 64 patients with 60 fully implanted patients, demonstrated the implantable intravascular delivery system efficiently delivered treprostinil with low rate of catheter-related complications.
The ISR system is suggested for adult patients with class I, II and III pulmonary arterial hypertension (PAH) receiving intravenous delivery of Remodulin.
According to the company, around 10% of patients experienced pump failures after four years of use, during the pivotal clinical trial for the ISR system.
PAH is a debilitating and progressive disease, which causes high blood pressure in the pulmonary arteries and results in right-heart failure and premature death. The disease mostly affects women.
Medtronic cardiac and vascular group’s heart failure business general manager Dr 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.”
In July this year, Medtronic commenced a new clinical trial assessing the electrocardiography (ECG) Belt research system (ECG Belt) as a diagnostic tool to optimize cardiac resynchronization therapy (CRT) for patients with heart failure.
The ECG Belt, which is investigational, has not yet approved for sale in the US.
Initially, the prospective, randomized, interventional and investigational trial will recruit patients in 10 centers across the US.