Proven Process Client Flowonix Medical Inc. Achieves FDA PMA(S) Approval of Prometra II Infusion Device

Tuesday, March 31, 2015 - 14:45

New flow-activated valve design allows patients with implanted devices to undergo MRI procedures

Mansfield, MA – March 31, 2015 – Proven Process Medical Device, Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today that its client Flowonix Medical Inc. has secured PMA-Supplemental approval from the FDA for its next-generation intrathecal infusion device, the Prometra® II system. Approval of this device, created with the assistance of Proven Process’ design and manufacturing services, will enable Flowonix to proceed with product introduction in the coming months. The groundbreaking design for the Prometra II’s flow-activated valve was made possible in part by Proven Process’ Concept-to-Customer approach which helped Flowonix achieve important milestones and approvals for a successful product introduction.

The drug infusion device is novel in many ways, most significantly for its patented flow-activated safety valve (FAV™), which allows patients to have an MRI without the necessity of drug removal prior to the procedure. MRI systems tend to emit significant electromagnetic energy that can interfere with operation of a patient’s implanted device. The Prometra II increases patient safety and clinical convenience by providing safe, dependable, automatic dosing of drugs directly into the intrathecal space around the spine. The Prometra II’s innovative FAV was designed to shut off drug flow to the patient in the event a high flow rate occurs during an MRI procedure.

"The new Prometra II drug infusion device is a major breakthrough for Flowonix, physicians and patients, since it will improve the MR compatibility of the already state-of-the-art Prometra drug infusion device," remarked Steve Adler, President and CEO of Flowonix.

With over 20 years of experience designing and manufacturing Class II and Class III medical devices for prominent global healthcare brands as well many start-up entities, Proven Process understood the technologies and best solutions to successfully create the small, self-contained, battery-powered device that delivers intrathecal pain therapy needed by over 100 million Americans suffering from chronic pain. The company’s vast experience ranges from implantable medical devices to complex cardiac devices, in-vitro diagnostic devices, disposables, robotics and sterile kits. Proven Process partnered with Flowonix to design and manufacture the newest addition to its brand of state-of-the-art Prometra drug infusion devices.

Proven Process’ Concept-to-Customer process guides medical device manufacturers seamlessly through the device development process, from a nascent idea to a feasible concept, then on to final design, verification, manufacturing and through the regulatory process.

"As a proven design and manufacturing partner to the medical device industry, our expert approach takes into account the numerous challenges associated with bringing a new product to market,” said Ken Fine, Proven Process President and Co-founder. “It is an exciting opportunity to work with companies like Flowonix and leverage our expertise in designing complex, high-risk products from concept to completion to help bring these groundbreaking innovations to market successfully, and we look forward to participating in Flowonix’s continued success.”


About Proven Process
Proven Process Medical Devices Inc. is one of the industry’s leading designers and manufacturers of Class II and Class III medical devices. The company was founded in 1994 to address the unmet need for an outsourced provider to the medical device industry with the in-depth technical, quality and regulatory knowledge needed to develop and manufacture sophisticated medical products. To ensure success, the company founders developed a "Proven Process," which combines creative, state-of-the-art R&D, with exceptional design, process, and quality controls to achieve new product development and manufacturing success. For more information, visit or follow us on Twitter @ProvenProcess.


For more information, contact:

Mike Kanis, Sales Engineer

Proven Process Medical Devices

(508) 261-0849