Pain pump gets the go-ahead
Flowonix Medical is granted FDA approval for its Prometra II 40 mL Programmable Pump system
MOUNT OLIVE, N.J.—Flowonix Medical, Inc. has announced approval from the U.S. Food and Drug Administration (FDA) to market the company’s Prometra II 40 mL Programmable Pump and its associated programmer software.
This system approval expands the reservoir size options to include both 20 mL and 40 mL pumps and includes the claim of a 10-year battery life at average flow rates, which the company believes may reduce the amount of replacement surgeries for patients. The pump is designed to operate identically to the previously approved 20 mL pump, which has shown clinical benefits for many of the 7,000 patients implanted worldwide.
“The launch of the Prometra II 40 mL Programmable Pump is an important step for Flowonix,” said Larry Heaton, president & CEO of Flowonix Medical. “This allows us to promote the substantial benefits of the Prometra system for patients who are best served by 40 mL pumps, in particular patients who suffer from Cancer pain. We are excited to enter this underserved clinical market for many reasons, including the opportunity for Flowonix to grow market share, 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.”
The first implant of the Prometra II 40 mL pump was performed October 21st in Scottsdale, Arizona by interventional pain physician Lisa Stearns M.D., a world leader in the treatment of cancer pain. Stearns, a pioneer in the field and a co-founder of the Cancer Pain Research Consortium, has performed extensive clinical research in the use of intrathecal drug delivery versus the use of oral opioids.
“With the addition of a 40 mL pump to the product line, physicians and patients can now choose the appropriate pump best suited to their own clinical needs. 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,” Stearns noted, following her first use of the 40 mL Prometra II pump.
“Patients can now enjoy the benefits of Prometra Technology, including novel infusion modes, consistently accurate dosing, and the potential for reduced dosage requirements, all while reducing the frequency of refill appointments,” added 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.”
The Prometra Programmable Infusion System is FDA approved for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution. The new 40 mL pump also includes an update to the recently approved Maestro Programmer, which builds on the existing platform.