US FDA approval for SynchroMed II implantable system for treating pulmonary arterial hypertension

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Medtronic has received US FDA approval for its implantable system for Remodulin to treat patients with pulmonary arterial hypertension. Through a first-of-its-kind collaboration, a press release reports, the SynchroMed II drug delivery system and cardiac catheter technologies were leveraged to deliver the pulmonary arterial hypertension medication Remodulin (treprostinil) injection developed by United Therapeutics Corporation. United Therapeutics will lead the commercial promotion of the ISR, with Medtronic support.

The system is composed of the 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 pulmonary arterial hypertension trial (a prospective, single-arm, non-randomised, open-label study conducted at 10 sites in the USA). 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.

David Steinhaus, general manager of the Heart Failure business, part of the Cardiac and Vascular Group at Medtronic, says: “External infusion pumps have been used to deliver prostacyclins for pulmonary arterial hypertension, 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.”

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