FDA Approves Flowonix Maestro Software for Pump Programming

The US Food and Drug Administration (FDA) has approved the marketing of Flowonix Maestro Software for Clinician Programmers. The new software is used to program Prometra Pump Systems.

Flowonix Maestro Software was designed to help both clinicians and patients by improving the user experience. It builds on the software currently used with Prometra Clinician Programmer. The Prometra Programmable Infusion Pump System is used for intrathecal delivery of drugs including Infumorph (preservative-free morphine sulfate sterile solution), saline solution, and baclofen.

"Physicians continue to be drawn to the Prometra System due to its ability to provide consistently accurate dosing using a novel micro-bolus delivery mechanism that delivers medication rapidly and broadly to the spinal cord," said Jason Poston, MD, an interventional pain physician in Idaho Falls, Idaho, in a statement. "The easy-to-use Flowonix Maestro Software will further simplify the process of introducing this pump technology into physicians' practices, and, more importantly, increase the opportunities for patients to benefit from it."

Improvements to the new software include automatic calculations, greater flexibility in dosing during bridge bolusing, enhancements to Periodic Flow and Multiple Rate Flow capabilities, and modifications to the programmer workflow designed to reduce complexity and ensure necessary steps are taken during programming.

The company plans to introduce and begin implementing the Flowonix Maestro Software this month.

"We are excited to introduce the Flowonix Maestro Software into clinics around the country, as the enhancements included in the software were driven by feedback provided directly by our customers," said Larry Heaton, President and CEO of Flowonix Medical, Inc, in a statement. "We are confident the combination of the Flowonix Maestro Software and the novel drug delivery mechanism of the Prometra Pump will strengthen our position in the marketplace and set the company up for long-term success in targeted drug delivery.