FDA Approves Medtronic’s Implantable System for Remodulin for Treatment of PAH

The U.S. Food and Drug Administration has approved Medtronic’s Implantable System for Remodulin, or ISR, to deliver Remodulin to patients with pulmonary arterial hypertension (PAH).

PAH patients have high blood pressure in their pulmonary arteries, those that carry blood from the heart to the lungs, which can cause damage to both the lungs and heart. Vasodilators — agents that help dilate blood vessels and encourage a proper blood flow — are often used by PAH patients.

The prostacyclin Remodulin (treprostinil), made by United Therapeutics, is an effective vasodilator and has been shown to widen blood vessels and reduce blood pressure.

Many patients are administered Remodulin intravenously through the use of external infusion pumps. But this places a significant burden on patients.

One of the major benefits of ISR is that it is implantable, which takes away some of that burden and reduces the risk of complications such as infections.

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“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,” David Steinhaus, MD, general manager of the heart failure business in the Cardiac and Vascular Group at Medtronic, said in a press release.

“This fully implantable drug delivery system was designed to address these serious patient care concerns,” he said.

Medtronic’s ISR comprises the company’s SynchroMed II implantable drug infusion pump and a newly developed intravascular (in a blood vessel) catheter that is designed to deliver remodulin intravenously to patients.

The ISR is indicated for adult patients receiving intravenous delivery of Remodulin with class I, II and III PAH. Class IV patients, with severe disease symptoms, are excluded.

Medtronic was responsible for applying for regulatory approval for the device, while United Therapeutics was responsible for regulatory approval of Remodulin.

The FDA’s approval of the pump and delivery device was based on data collected from the DelIVery for PAH clinical trial (NCT01321073), which was conducted at 10 sites in the U.S. with 60 PAH patients successfully implanted with the device.

Results from the trial indicated the device was effective at delivering Remodulin, with a low rate of catheter-related complications and a high rate of patient satisfaction.

The commercial promotion of the ISR will be led by United Therapeutics with support from Medtronic.