Medtronic is partnering with United Therapeutics to launch a therapy that could help treat patients with pulmonary arterial hypertension (PAH). The Dublin-based company said it has received FDA approval for the Implantable System for Remodulin (ISR).
In the collaboration, Medtronic’s SynchroMed II drug delivery system and cardiac catheter technologies were used to deliver the PAH medication Remodulin (treprostinil) Injection developed by United Therapeutics.
PAH is a severely debilitating and progressive disease that causes high blood pressure in the pulmonary arteries, ultimately resulting in right-heart failure and premature death. It predominantly affects women, who are typically diagnosed in their late 30s to early 50s.
"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, M.D., general manager of the Heart Failure business, part of the Cardiac and Vascular Group at Medtronic said in a release. "This fully implantable drug delivery system was designed to address these serious patient care concerns."
The system is composed of the company's SynchroMed II implantable drug infusion pump and a newly developed intravascular catheter to deliver Remodulin intravenously to patients who have previously been receiving Remodulin intravenously via an external infusion pump. Medtronic and United Therapeutics pursued parallel regulatory filings for the device and drug, respectively.
FDA approval was based on the DelIVery for PAH trial, a prospective, single-arm, non-randomized, open-label study conducted at 10 sites in the U.S. It enrolled 64 patients (60 successfully implanted) and showed the implantable intravascular delivery system effectively delivered treprostinil, with a low rate of catheter-related complications, and a high rate of patient satisfaction. The move comes on the heels of FDA approving a new clinician programmer for Medtronic’s Synchromed II, as well as a series of recent design changes aimed at improving the pump s a pain management device.