Flexi-Q DV: Fully Disposable Auto-Injector for Drugs in Vials
The Flexi-Q DV auto-injector is a fully disposable auto-injector for drugs in vials (in both lyophilized and liquid forms). It is the only commercially available device that provides a unique and user-friendly solution for self-administration of such drugs. This single-use auto-injector allows simplified reconstitution and aspiration from conventional vials, features safe needle shielding throughout the process, provides life cycle management capabilities for new and existing drugs, encourages better patient compliance and improves safety in self-injection.
Regulatory Status – FDA 510(k) cleared.
This product is owned by Elcam Medical. For sub-licensing and customization options, contact Dr. Menachem Zuker from Elcam Medical.
BENEFITS
- Novel vial adaptor. Clicks on the auto-injector to enable easy drug reconstitution. Eliminates several steps in the reconstitution process and simplifies drug reconstitution.
- Optimizes drug extraction from vial. Designed to optimize vial drug removal and enhance dosing consistency.
- Reconstitution of hard-to-dissolve-drugs. Allows swirling and time delays followed by user inspection before performing the automatic injection.
- Enhances patient acceptance. A hidden needle during all the reconstitution operation; and before, during, and after injection minimizes needle phobia.
- Quiet operation. Reduces patients’ anxiety and perceived pain.
- Reduced local skin reaction. Injection starts only after full needle penetration is achieved.
- Simplified regulatory path. For approved products delivered by subcutaneous bolus injection, simplified 510(k) and CE mark regulatory paths.
- Accommodates a variety of protocols. Designed to reconstitute and inject one or more drug vials with variable volume of diluents.
