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Medtronic partners 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 remodulin system (ISR).
In collaboration, Medtronic's SynchroMed II drug delivery system and cardiac catheter technologies were used to deliver remodulin. developed by United Therapeutics.
PAH is a severely debilitating and progressive disease that causes high blood pressure in the pulmonary arteries, ultimately leading to right heart failure and premature death. It mainly affects women, who are usually diagnosed between the 30s and early 50s.
"External infusion pumps were used to administer prostacyclines against PAH, but management imposes a significant burden to patients, harms their daily activities, and exposes them to a high risk of infections, "said David Steinhaus, MD, general manager of heart failure activity , part of the heart and vascular group at Medtronic, said in a statement. "This fully implantable drug delivery system has been designed to address these serious concerns."
The system includes the company's SynchroMed II implantable infusion pump and a newly developed intravascular catheter to deliver Remodulin intravenous to previously treated patients. receiving Remodulin intravenously via an external infusion pump. Medtronic and United Therapeutics have pursued parallel regulatory filings for the device and the drug, respectively.
The FDA's approval was based on the DelIVery for PAH study, an open, prospective, nonrandomized, single-arm study conducted at 10 sites in US It recruited 64 patients ( 60 implanted successfully) and showed that the implantable intravascular delivery system effectively administered treprostinil, with a low rate of catheter-related complications, and a high rate of patient satisfaction. This decision follows the FDA's approval of a new clinician programmer for Medtronic's Synchromed II, as well as a series of design changes aimed at improving the pain management device of Medtronic. the pump.
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