Medtronic (NYSE:MDT) said today that it won FDA approval for its implantable drug-delivery system designed to administer United Therapeutics‘ (NSDQ:UTHR) pulmonary arterial hypertension drug, Remodulin.
United Therapeutics is slated to take the lead on commercial promotion of the drug-device system, with support from Medtronic.
The system includes Medtronic’s SynchroMed II implantable pump and a new intravascular catheter that delivers Remodulin intravenously to patients who have previously received Remodulin via an external infusion pump.
“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,” Dr. David Steinhaus, GM of Medtronic’s heart failure business, said in prepared remarks. “This fully implantable drug delivery system was designed to address these serious patient care concerns.”
The product’s launch was delayed in April last year due to “complexities related to the parallel [regulatory] filings” that the companies pursued for the drug and the device.
Medtronic’s implantable drug pump faced its own problems last year after the FDA issued a Class I recall in March for the SynchroMed II and EL pumps due to a priming bolus issue. The two issues – the recall and the delayed launch – were not related, according to a Medtronic spokesperson.