Medasys Prometra implantable drug pump wins FDA PMA approval

The US Food and Drug Administration (FDA) has granted a premarket approval (PMA) to Medasys' Prometra programmable implantable drug pump.

Prometra is a non-peristaltic programmable implantable pump which delivers Infumorph (preservative-free morphine sulfate sterile solution) intraspinally to manage pain.

The Prometra also uses a patented valve gated precision dosing system to achieve extremely high accuracy, minimize dose variations due to temperature, pressure, flow rate, or reservoir fill levels.

Medasys said a clinical trial also showed 97% clinical accuracy in the delivery of the physician-programmed dose.