About Implantable System for Remodulin
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 percent of patients experienced pump failures after four years of use. At least 33 percent 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.


Potential adverse events for the Implantable System for Remodulin include: air embolism; allergic or immune system response; anesthesia-related nausea and vomiting; back pain related to lying on the table; catheter dislocation from the vasculature; catheter occlusion; component failure resulting in loss of therapy or inability to program the pump; damage to components; death; disconnection or breakage; erosion; fibrillation and other arrhythmias; hematoma; hemorrhage and exsanguination; improper injection through the catheter access port; infection or sepsis; injection into pocket or subcutaneous tissue; local or systemic Remodulin toxicity and related side effects; low-grade fever; mild or moderate bruising or ecchymosis; nerve damage; overfilling the reservoir; pulmonary arterial hypertension symptoms-mild exacerbation; pain; pneumothorax and hemothorax; pocket site and incisional pain; poor healing over the pump and catheter incisions; premature end of device service life; programming error; pulmonary embolism or paradoxical embolism; pump inversion or migration; puncture of diaphragm, abdominal organs, or thoracic organs; Remodulin overdose; Remodulin subcutaneous delivery; Remodulin underdose and abrupt cessation; seroma; shoulder pain, discomfort, or stiffness; sleep problems (insomnia); stroke; underdose; venous or arterial dissection or perforation; and venous thrombosis, occlusion, stenosis, insufficiency, or phlebitis.

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