• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA approves Flowonix’s Prometra II programmable pump

October 25, 2019 By Sean Whooley

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.”

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: Flowonix Medical

IN CASE YOU MISSED IT

  • Senseonics closes public offering, private placement with Abbott
  • Embecta eyes shift from insulin delivery to broader medical supplies focus
  • Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
  • Sequel Med Tech to pair automated insulin delivery system with Abbott’s future dual glucose-ketone sensor
  • Medtronic to separate Diabetes business unit

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS