Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion.
The pump has expanded reservoir size options that include 20 ml and 40ml pumps, along with the claim of 10-year battery life at average flow rates. Flowonix said in a news release yesterday that the Prometra II is designed to operate identically to the previously approved 20 ml pump.
The pumps are approved for intrathecal infusion of drug therapies, such as Infumorph (preservative-free morphine sulfate sterile solution) and preservative-free sterile 0.9% saline solution (sodium chloride injection, USP). Flowonix said the first Prometra II 40 ml pump was implanted earlier this week in Scottsdale, Ariz. by Dr. Lisa Stearns.
The launch of the Prometra II 40 ml programmable pump allows Flowonix to offer the Prometra system to people best served by 40 ml pumps, including cancer patients, according to Larry Heaton, Flowonix’s president and CEO.
Heaton in a news release described the “dramatic cost savings targeted drug delivery can provide versus oral opioids, and most importantly, the clinical benefits to cancer pain patients including better pain management, reduced side effects and improved cognition.”
Stearns added: “The larger reservoir, programming options, and battery life will improve patient outcomes and ultimately reduce healthcare utilization long-term. All patients deemed appropriate for intrathecal therapy, whether suffering from chronic non-malignant or cancer-related pain will benefit from this therapy.
The new pump can reduce the frequency of refill appointments, said Flowonix product manager Nicolette Pappas. “This is especially meaningful to those patients that have difficulty getting to their doctor’s office for transportation or mobility reasons.”