Flowonix’s Latest Approval Won in Part Due to Partnership With Proven Process Medical Devices

Mt. Olive, N.J.-based Flowonix Medical Inc. recently received supplemental premarket approval from the U.S. Food and Drug Administration for Prometra II, the company’s next-generation intrathecal infusion device.

The system was created with the assistance of Mansfield, Mass.-based Proven Process Medical Devices Inc., which specializes in the design, development, validation and manufacture of class II and class III medical devices.
Flowonix plans to proceed with product introduction in the coming months.

According to officials from Flowonix, the 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 a magnetic resonance imaging (MRI) procedure without the necessity of drug removal prior to the procedure, according to Flowonix officials. MRI systems emit significant electromagnetic energy that can interfere with the operation of a patient’s implanted device. The Prometra II increases patient safety and by providing safe, dependable, automatic dosing of pharmaceuticals directly into the intrathecal space around the spine. The FAV was designed to shut off drug flow to the patient in the event a high flow rate occurs during an MRI.

“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 Prometra drug infusion device,” said Steve Adler, president and CEO of Flowonix.

With more than 20 years of experience designing and manufacturing medical devices, Proven Process understood the technologies and best solutions to successfully create the small, self-contained, battery-powered device.

Proven Process partnered with Flowonix to design and manufacture the newest addition to its line of Prometra drug infusion devices.
“As a proven design and manufacturing partner to the medical device industry, our approach takes into account the numerous challenges associated with bringing a new product to market,” Ken Fine, Proven Process president and co-founder, said in prepared remarks. “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.”

Proven Process’ experience ranges from implantable medical devices to complex cardiac devices, in-vitro diagnostic devices, disposables, robotics and sterile kits.