Flowonix submits MRI-compatible implantable infusion pump for FDA approval

Flowonix's Prometra--Courtesy of Flowonix

Pending FDA approval, the upgraded Prometra Implantable Pump System for the targeted delivery of pain medication will feature MRI compatibility, Flowonix CEO Steve Adler told FierceDrugDelivery in an interview.

The Mount Olive, NJ, company announced its PMA supplement submission to the FDA for the upgraded Prometra on Sept. 15 but chose not to disclose the MRI compatibility plans at that time, Adler said. He said the submission contains data demonstrating MRI compatibility, and he does not expect the FDA to request a clinical trial, but he could not specify a date by which the application will be reviewed.

The Prometra delivers the generic drug morphine (commonly marketed as Infumorph) to the intrathecal space in the spine because that is preferable to systemic delivery, Adler said.

Adler wouldn't give too many details, but he said the goal is to achieve MRI compatibility by making as few changes to the device as possible. FDA approval of the PMA supplement would give Flowonix a significant edge over the other implantable infusion pump, Medtronic's SynchroMed II.

"Our competition hasn't had a new product in over 20 years," Adler said. In fact, an inspection of the FDA's approval database shows that the SynchroMed II has had more than 200 successful PMA supplements since its inception in 1988, indicating modifications from changes in labeling to small product upgrades. Similarly, the Prometra has 20 PMA supplements to its name since initial approval in 2012.

But as far as PMA supplements go, MRI compatibility would be a pretty significant modification with strong clinical implications. Metallic devices can heat up or malfunction during an MRI scan, the FDA says. In addition, loose metallic objects can cause injury if they get pulled toward the magnet during the scan.

Manufacturers of pacemakers are also trying to develop MRI-compatible versions. Patients with noncompatible devices have to use alternative methods of diagnosis that may not be as effective as MRI, Adler said.

The other proposed upgrades in Prometra's PMA supplement include new controllers for the patient and clinician as well as enhanced bolus delivery modes for rapid intravenous delivery.

- read the release

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