Medtronic won FDA approval for its Implantable System for Remodulin (ISR) as a new treatment option for people with pulmonary arterial hypertension. It consists of Medtronic’s Synchromed II drug delivery system, an intravascular catheter, and United Therapeutics‘ Remodulin (treprostinil) Injection medication.
Unlike external infusion pumps, the Implantable System for Remodulin is completely implantable, reducing infection risk and reducing the difficulty of delivering treatment.
Some info on the study that led to the new approval:
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 United States. 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.
Product page: SynchroMed II Drug Infusion System…
Via: Medtronic…