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Flexi-Q PDVR™

Flexi-Q PDVR represents a unique and enclosed solution for the automated injection of drugs in vials. It is the only commercially available device that provides a unique and user-friendly solution for reconstitution and automated injection of lyophilized drugs in vials.

This disposable auto-injector incorporates fully-enclosed and simple drug preparation, offering lifecycle management capabilities for both new and existing products. 

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Pharmaceutical Company Advantages

Differentiation

  • Provides a unique drug delivery solution for drugs in vials
  • Vial Adaptor system minimizes risk of contamination during preparation
  • Suitable for both fixed and patient-specific dosing
  • Provides flexibility – the diluents may be contained in either vials or pre-filled in the injector (in a standard glass syringe)
  • Optimizes drug extraction from vial – designed to optimize vial-drug removal and enhance dosing consistency
  • Reduced local skin reactions – injection starts only after full needle penetration
  • Vented vial adaptor, vial sizes, color coding flexibility and other customization options

Short regulatory path

  • Compatible with standard glass syringes and vials – no need to change drug container
  • Regulatory path (depending on configuration) – 510(k), CE Mark

Patient Benefits

Ease of use and convenience

  • Fully automatic injection process
  • Quite injection reduces patients’ anxiety and perceived pain
  • Reduces needle phobia – by hiding the needle throughout the entire reconstitution and injection process
  • Easy titration and expelling of air bubbles using the long observation window

Safety

  • Prevents needle-stick injuries – needle is protected throughout the entire process of reconstitution and injection
  • Reduced local skin reactions – injection starts only after full needle penetration into the correct depth (SC)
  • Clear visual and audible confirmation of the injection progress from beginning to end
  • Propriety feature prevents expensive drug spillage during aspiration and injection
    Prevents false activation during all steps
Regulatory Status – FDA 510(k) cleared

User Steps

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1. Connect the vial to the Vial Adapter, and then connect the Vial Adapter
2. Press Plunger and inject diluent into Vial.
3. Reconstitute by swirling.
4. Pull the plunger to withdraw the drug into the device and prime. Disconnect the Vial Adapter and prime.
5. Press device against injection site and press Injection Button. After completion of injection, remove device from injection site and dispose.