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Another baclofen pump option, The Prometra II by Flowonix

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    Another baclofen pump option, The Prometra II by Flowonix

    I just saw this, so wanted to pass it along. I don't believe it is compatible with the catheter used with Medtronic's Synchromed II pump, so unfortunately wouldn't be an option for pump only replacements.

    The Flowonix’s Prometra II Pump System Receives FDA Approval for Use with Intrathecal Baclofen

    February 21, 2020

    The U.S. Food and Drug Administration (FDA) has granted approval to Flowonix Medical’s Prometra II Programmable Pump System for use with intrathecal baclofen for the treatment of spasticity across numerous conditions, including multiple sclerosis.

    Intrathecal baclofen — sold as Gablofen by Piramal, Lioresal by Saol Therapeutics, and also in generic formulations – is administered via an injection into the spinal canal. It is a skeletal muscle relaxant used to treat spasms, pain, and stiffness. It was designed for individuals who cannot tolerate oral baclofen, or who do not experience relief from tablets.

    Unlike the currently available motor-driven pump, the Prometra II Pump uses a pressure-driven, valve-gated delivery system that transports the medication (in this case, baclofen) into the intrathecal (spinal) space. This innovative delivery system allows the medication to be infused quickly, with a broad dispersion, into the spinal cord.

    The system can be programmed, using a hand-held remote device, to have periods of flow followed by periods of no flow, which is unique to the Prometra device.

    The Prometra II Pump also has a battery life of more than 10 years, which substantially reduces the amount of future surgical procedures that patients have to go through to replace the pump.

    “Over the last several years, physicians utilizing implantable pumps to deliver long-term baclofen infusions have only had one device option,” Charles Argoff, MD, a neurologist at Albany Medical Center, said in a press release.

    “The availability of a totally new pump to assist in the management of severe spasticity allows for a meaningful new option for those patients who suffer from this condition,” Argoff said.

    The American Association of Neurological Surgeons estimates that more than 12 million people in the world experience spasticity symptoms, including patients with multiple sclerosis, but also cerebral palsy, spinal cord injury, traumatic brain injury, and stroke.

    Flowonix originally introduced the 40 milliliter (mL) Prometra II pump in the U.S. market in late 2019, giving patients and physicians a choice between 20 mL and 40 mL capacities.

    This new indication now expands the market for the Prometra device by allowing its use in the treatment of spasticity. Flowonix has plans to start marketing the device for the new indication immediately.

    “This is a major milestone for Flowonix,” said Larry Heaton, president and CEO of Flowonix Medical. “We believe the community of clinicians treating severe spasticity with intrathecal baclofen will find the Prometra System to be a welcome addition to their armamentarium for treating their patients, and we will be working with leading physicians in the field to establish Prometra as the standard of care in intrathecal baclofen therapy.”

    To date, the Prometra System has been implanted in more than 8,000 patients worldwide, including patients with severe spasticity in the United Kingdom and European Union, where it was approved in 2011.

    Aside from baclofen, the Prometra II Programmable Infusion Pump System is approved for the intrathecal infusion of two other therapies — Infumorph (preservative free morphine sulfate sterile solution), and preservative-free sterile 0.9% saline solution (Sodium Chloride Injection).

    https://multiplesclerosisnewstoday.c...ecal-baclofen/
    Kimba

    “When you change the way you look at things, the things you look at change.” ― Max Planck

    #2
    The Flowonix pumps are not fully MRI compatible and must be emptied prior to MRI procedures.

    Warning: EMPTY ALL DRUG SOLUTION FROM PROMETRA II PUMPS PRIOR TO ENTERING THE MRI ENVIRONMENT.

    Strong magnetic fields, such as those created in MRI scanners, may cause the Inlet and Outlet Valves to open, resulting in the immediate discharge of the contents of the Drug Reservoir and Catheter into the patient.

    https://flowonix.com/sites/default/f...structions.pdf

    Comment


      #3
      Originally posted by Marco View Post
      The Flowonix pumps are not fully MRI compatible and must be emptied prior to MRI procedures.

      Warning: EMPTY ALL DRUG SOLUTION FROM PROMETRA II PUMPS PRIOR TO ENTERING THE MRI ENVIRONMENT.

      Strong magnetic fields, such as those created in MRI scanners, may cause the Inlet and Outlet Valves to open, resulting in the immediate discharge of the contents of the Drug Reservoir and Catheter into the patient.

      https://flowonix.com/sites/default/f...structions.pdf
      I noticed that, and was just about to update my post. Thanks, Marco.

      For those new to the pump, only someone who has the proper training and equipment can empty or refill a bacoflen pump. Then there's access to the medication. There are only certain specialized pharmacies that carry it.

      Additional steps and costs that aren't necessarily the most practical every time you need a need a MRI.
      Kimba

      “When you change the way you look at things, the things you look at change.” ― Max Planck

      Comment


        #4
        Can you imagine up to 40 ml of Lioresal/Morphine/etc being dumped in your body?

        There have even been a few documented deaths due to pumps leaking...

        Comment


          #5
          Originally posted by Marco View Post
          Can you imagine up to 40 ml of Lioresal/Morphine/etc being dumped in your body? There have even been a few documented deaths due to pumps leaking...
          I've had a couple revision surgeries over the years with my Baclofen pump, but the migration
          could be caused by this pump as well (MS has left me with "mushy muscles and fascia" and several
          times the pump has gone on a walkabout...but surgery was easy to relocate it to it's original
          position.) I had one time the catheter snaked it's way out of my spine and was still pumping
          baclofen into my body. The pump didn't sound because in it's "opinion" it was still pumping
          and working fine...it couldn't detect a problem. I realized it because 1/2 of my abdomen looked like I had swallowed a watermelon, whole. So they turned off the pump ( put me in the hospital on some benzo which evidently is the treatment for overdose) until they could schedule the surgery to get the catheter replaced and hooked back up to the pump.

          But as far as the Baclofen pump..."if it ain't broke, why fix it". I would see no incentive for me in
          replacing the pump with a "new" less tested, pump.

          Comment

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