Medasys has received FDA pre-market approval for its Prometra programmable implantable drug pump. The Prometra is a non-peristaltic programmable implantable pump that delivers INFUMORPH (preservative-free morphine sulfate sterile solution) intrathecally for the management of pain.
The Prometra makes use of a valve gated precision dosing system to achieve high accuracy, minimizing dose variations due to temperature, pressure, flow rate, or reservoir fill levels. It has a minimal amount of moving parts and no complex gears and rotors.
The pump is implanted near the spine and has a microcatheter that runs to the intrathecal area of the lower spine. The intrathecal delivery makes it possible to use very low doses compared to other routes of administration, thus minimizing the risk of side-effects and lowering the amount of medication needed in the reservoir. The reservoir can be refilled percutaneously with a syringe and a needle.
Press release: Medasys Inc. Announces FDA Approval for Implantable Programmable Drug Pump…
Product page: Medasys Pumps…