Medtronic and United Therapeutics received premarket approval from the FDA for a fully implantable drug delivery system that continuously administers Remodulin (treprostinil) through a cardiac catheter to treat pulmonary arterial hypertension.
The two companies had filed parallel submissions with the agency, with Medtronic providing its SynchroMed II implantable infusion pump and a new intravascular catheter, which will carry up to 16 weeks’ worth of United’s Remodulin, for patients that have previously been receiving the drug via an external infusion pump. United will lead the commercial promotion of the system, with Medtronic’s support.
Remodulin was approved by the FDA in the early 2000’s as a vasodilator to treat PAH via subcutaneous and intravenous infusions through a central indwelling catheter, which can carry a risk of sepsis. PAH is a progressive disease causing high blood pressure in the pulmonary arteries and eventually heart failure.
“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 Medtronic’s heart failure business arm. “This fully implantable drug delivery system was designed to address these serious patient care concerns.”
Approval of the system—refilled using a syringe through the patient’s skin, with a battery life of four to seven years—was based on a prospective, single-arm, open-label study of 60 patients that demonstrated a low rate of catheter-related complications, at below 2.5 per 1,000 patient-days, the companies said. The study met its primary objective in 2013, and 10% of patients experienced pump failures after four years of use.
“We are extremely excited to offer this new option to patients suffering from PAH,” United Chairman and CEO Martine Rothblatt, Ph.D., said in a statement. “During the course of the DelIVery study, we received considerable physician and patient interest in the [implantable system]. We are grateful to our collaborators at Medtronic for reaching this milestone and look forward to continuing our collaboration.”
In 2013, the FDA approved an oral formulation of Remodulin’s active ingredient, Orenitram, after twice rejecting United’s applications. That approval was narrower, with the twice-daily tablet aiming to help patients improve exercise capacity.