Implantable system for Remodulin receives FDA approval
Medtronic has received FDA approval for the Implantable System for Remodulin (ISR) to treat patients with pulmonary arterial hypertension (PAH). Through a first-of-its-kind collaboration, the Medtronic SynchroMed II drug delivery system and cardiac catheter technologies were leveraged to deliver the PAH medication Remodulin (treprostinil) Injection developed by United Therapeutics. United Therapeutics will lead the commercial promotion of the ISR, with Medtronic support.
PAH is a severely debilitating and progressive disease that causes high blood pressure in the pulmonary arteries, ultimately resulting in right-heart failure and premature death. It predominantly affects women, who are typically diagnosed in their late 30s to early 50s.
"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," said David Steinhaus, M.D., general manager of the Heart Failure business, part of the Cardiac and Vascular Group at Medtronic. "This fully implantable drug delivery system was designed to address these serious patient care concerns."
The system is composed of the Company's 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 PAH trial, a prospective, single-arm, non-randomised, 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.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
The Implantable System for Remodulin is indicated for adult patients with Class I, II and III pulmonary arterial hypertension (PAH) receiving intravenous delivery of Remodulin.
Warnings and Precautions include: failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose.
During the pivotal clinical trial for the Implantable System for Remodulin, 10% of patients experienced pump failures after four years of use. At least 33% of these failures occurring after four years of use resulted in the device failing to deliver Remodulin without corresponding error alarm.
The remaining percentage of reported malfunctions occurred with a motor stall alarm that was reported by the patient. Patients who cannot tolerate a sudden cessation of Remodulin therapy may not be appropriate candidates for the Implantable System for Remodulin.
Patients with hearing loss may not be able to hear pump error alarms coming from the implanted pump, which may cause delay in therapy if the patient does not hear the alarm and contact the physician in a timely manner.
Sources of strong electromagnetic interference (EMI) can affect the operation of a pump. The Implantable System for Remodulin Technical Manual contains contraindications and the complete list of warnings and precautions.