It is finally here! The Food and Drug Administration approved Remodulin in its implantable delivery system for treatment of Pulmonary Arterial Hypertension. We have been providing updates on the 8-year study that investigated the use of an implanted pump to deliver Remodulin removing the need for external pumps and are excited to announce it is finally approved. The pump previously approved to treat neuromuscular and chronic pain conditions has been paired with a new catheter to deliver Remodulin into the vena cava (large vein near the heart) of Pulmonary Hypertension patients.
Benefits of Implanted Remodulin Pump
Remodulin has been used to treat PAH for many years, however this will be the first fully implantable device delivering a medication to treat Pulmonary Arterial Hypertension. Benefits of an implantable device include eliminating frequent refill of external pumps, eliminating external catheters and their risk of infection, and eliminating pain and irritation from subcutaneous infusion.
How Does the Implantable Remodulin Delivery System Work?
A small pump is implanted in the patient’s abdominal wall and a catheter runs from the pump to a large blood vessel in the patient’s chest/neck called the vena cava. The procedure itself is around 60 to 90 minutes. Like all procedures, implanting the pump has risks. Patients interested in having the pump placed would need to be evaluated by their physician to make sure they are healthy enough to tolerate the procedure. This procedure should only be done by PAH experts in a facility with experience caring for Pulmonary Hypertension patients. Refilling the pump involves a brief clinic visit where a needle is inserted through the abdomen into the pump. The timing and frequency of the refills depends on the dose of medication being infused. Refills should always be done with a Pulmonary Hypertension expert with experience caring for patients with the implantable pump.