Prometra II

The Prometra II programmable pump has been designed to administer the controlled dosage of drugs in the intrathecal space by means of an intrathecal catheter supplied separately. The Prometra II pump includes a patented Flow Activated Safety Valve (FAV™), that interrupts the flow of the drug to the patient in the event of an elevated flow presenting. The Prometra programmer is a handheld remote device supplied separately allowing the remote programming of the Prometra II pump. So as to help increase safety, the FAV™ safety valve (that activates with an elevated flow rate) allows its use during nuclear magnetic resonance (NMR).

Prometra features an exclusive precision dosing system (PDS) designed to administer medicines accurately and reliably, minimising the reservoir volume effect and environmental factors such as temperature and pressure. The PDS provides physicians with micro-dosing capabilities. With a useful year battery life of over 10 years, fewer pump replacement procedures may be required

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Characteristics and advantages

Prometra II characteristics and specifications

Prometra II characteristics and specifications

  • Suture ring: Improving the way the pump is anchored by incorporating a suture ring onto the pump, designed to provide a lower rate of suture complications and to prevent the internal growth of fibrotic tissue, which can complicate the process pump replacement in the future.
  • Refill septum: To improve the safety of refills, palpation of the port is improved by incorporating a 3mm raised ridge and wider opening, 61% wider than previous pumps. The silicone in the septum is rated to withstand an average of 1,000 punctures of the refill septum
  • Catheter access port: For safety, the catheter access port and needle are designed to be incompatible with the refill needle and port. This prevents the ports being confused and the possibility of giving a bolus with the total volume of the reservoir and causing a drug overdose.
  • FAV™, Flow Activated Safety Valve: The Prometra II pump includes a patented Flow Activated Safety Valve (FAV™), that interrupts the flow of the drug to the patient in the event of an elevated flow presenting.
  • Catheter connection: The pump features a “sutureless” connection with the redundant catheter lock that is able to resist over 4.5 Newtons of extraction force. As a mark of the success of this design innovation, during the clinical trial with 110 patients, there were no catheter disconnection complications.

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    *Prometra Vs Prometra II Comparison in MRI

  • Flexible catheter stem: Ensuring the catheter remains connected to the pump is vital, but patients often bend and stress the connection. However, our flexible pump stem is designed to be both easier to connect initially during implant and help to prevent any loss of integrity of the connection post-operatively. By being flexible it avoids the extra tension generated in the event of poor catheter fitting, preventing it kinking or obstructing.

Pump specifications

  • Height: 24 mm
  • Diameter: 69 mm
  • Empty weight: 150 g
  • Precision: 96.8%
  • Longevity: 10 years
  • Reservoir: 20 ml

Prometra® Catheter

 

The catheter is designed to work seamlessly with the Prometra Pump. It facilitates the correct placement and administration of medicines within the intrathecal space.

It has the following exclusive characteristics making it a unique option on the market:

  • Integrated flushing hub: the Prometra® catheter features an integrated guidewire flushing hub. This allows catheter lubrication without the need for soaking
  • Hydrophilic guidewire: The catheter is preassembled with a very hydrophilic coated guidewire. When flushed with saline, the hydrophilic coating is activated, generating lubrication helping to prevent bunching of the catheter when the guidewire is withdrawn.
  • Thick-walled design: durable, highly kink-resistant and long-lasting design. Also, the thick wall helps reduce the probability of catheter flow restriction.
  • Radiopaque tungsten tip: the Prometra catheter is precision-fitted with a radiopaque tungsten tip designed to provide high-contrast fluoroscopic visualization for easier and more accurate catheter placement.
  • Staggered dissemination ports: The staggered dissemination ports or fenestrations of the Prometra catheter help to achieve a more complete dispersion of the medication throughout the intrathecal space.
  • Graduated depth markings: the Prometra catheter features a graduated distal end with incremental markings, which help more precise depth positioning during intrathecal insertion.
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*Prometra catheter tip

Programmer and accessories

The Prometra programmer is a portable device for the purpose of externally programming the Prometra® Pump. It has been designed to be ergonomic and very easy to use, with a clear backlit screen and intuitive user interface. It can be used for a wide variety of tasks, including: programming the pump to adjust constant medicine flow rates, setting up complex medicine delivery schedules, reviewing programming history, and printing patient records etc. The Prometra Programmer is also used to provide boluses, keep track of refill information, or stop the pump.

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*Prometra programmer

Accessories:

  • Refilling Kit: The Prometra ®refilling kit contains the components the doctor will require for the correct refilling of the medicine in the pump. Physicians can easily locate the septum through palpation; a raised ring around the pump's refill septum aids identification and differentiates it from the catheter access port. As a supplemental safety feature, the refill kit contains a template and needle that has been designed to be incompatible with the catheter access port (CAP) and only function in the refill septum. The non-perforating tip design allows liquid to exit the needle and enter the reservoir in a way that is designed to be incompatible with entry into the CAP.
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*Prometra II Refill Kit

 

  • Catheter or bolus access kit: The Prometra Catheter Access Port (CAP) kit contains the different components necessary for the correct use of the catheter access port on the Prometra programmable pump to supply medication directly via the catheter. The correct location of the CAP is facilitated by the pump's teardrop design, the palpable raised ring surrounding the pump's refill septum and use of the template contained within the CAP kit. This intentional design and the tools provided offer an additional level of safety, supporting the high product quality objectives established by Flowonix. The non-perforating CAP needles contain discharge ports located too high to function correctly in the refill septum, which protects from confusing the CAP with the refill septum. For additional safety measures, the refill kit contains a separate template and needle specifically designed to identify and function in the refill septum and not the CAP. This template is different from the one found in the catheter access kit.

 

Catheter or bolus access kit

*Catheter or bolus access kit