New Jersey based implantable drug delivery specialist Medasys Inc., has announced that it has received PMA approval from the U. S. Food and Drug Administration (FDA) for its Prometra® programmable implantable drug pump. Prometra will be the first non-peristaltic programmable implantable pump that has received FDA approval for delivery of INFUMORPH (preservative-free morphine sulfate sterile solution). INFUMORPH is indicated for intraspinal administration for the management of pain.
In addition to meeting all of the PMA safety and effectiveness requirements, a clinical trial demonstrated 97% clinical accuracy in the delivery of the physician-programmed dose, the highest labeled accuracy available for this type of pump.
It is estimated that 116 million people in the U.S. suffer with chronic pain which can be debilitating, disabling, and negatively impact quality of life. Continuous intrathecal delivery of INFUMORPH using a microinfusion device such as an implantable drug delivery pump is a therapeutic option used for the management of chronic pain.
The Prometra product
Designs featured in the Prometra pump are intended to maximise device longevity and dose delivery accuracy in order to offer patients and physicians a new methodology in highly accurate drug delivery. Furthermore, by reducing the number of moving parts and eliminating complex gears and rotors, the company believes pump dependability and reliability should be greatly improved. The product also makes use of a patented valve-gated precision dosing system to achieve extremely high accuracy, minimising dose variations due to temperature, pressure, flow rate, or reservoir fill levels. It is expected that the combination of these factors will contribute to improved pain management.
“We are pleased to be able to utilize our engineering expertise and intellectual property to advance intrathecal therapy in the U.S.,” Steve Adler, President and CEO of Medasys commented. “Prometra represents the first significant evolution in pump technology available in the US in over 15 years.”
According to Medasys, Prometra attained CE Mark approval about a year ago and initiated a focused release of the Prometra in Italy and Greece through distributors. The company expects to release the product in the rest of the EU within the next few months.
Source: Medasys, PR Newswire