A majority of the patients who die of PAH in the United States each year have not initiated treatment with an infused prostacyclin analogue, which is a complex and burdensome form of medical therapy. In 2009, we entered into an agreement with exclusive rights in the United States with Medtronic, Inc. (Medtronic) to develop its SynchroMed® II implantable system (consisting of the SynchroMed II pump and a new catheter) to deliver Remodulin. If the SynchroMed II program is successful, it could reduce many of the patient burdens associated with infused prostacyclin analogues. Medtronic recently completed the DelIVery clinical trial, which we funded, in order to study the safety of the SynchroMed II system while administering Remodulin. The primary objective was to demonstrate a rate of catheter-related complications below 2.5 per 1,000 patient-days while using the SynchroMed II system to deliver Remodulin. In September 2013, Medtronic informed us that this primary objective was met (p<0.0001). Medtronic has not yet completed its analysis of numerous secondary endpoints, which will also have a bearing on the FDA device premarketing approval application (PMA) review process. In addition to the clinical study, Medtronic must complete other stability, compatibility and technical assessments of the SynchroMed II system, including modifications to its hardware and software, and address any outstanding regulatory issues.
Medtronic will make preparations to file a PMA seeking FDA clearance for the catheter and labeling changes, and will address any FDA feedback, to enable the use of the SynchroMed II system with Remodulin. In tandem, we plan to seek FDA approval of a supplement to Remodulin’s label to allow the use of Remodulin with the SynchroMed II system.