TM

VitrALA™ is intended for use for intravitreal injection preparations.  

 

VitrALA includes a closed-system sterilized header bag and integral 0.22-micron sterilizing grade filter, with a proprietary syringe tray that enables clinicians to fill, prime and accurately measure a minimum volume of 0.07 mL per syringe.  VitrALA minimizes drug loss with minimal dead space.  Syringes are capped and sealed to maintain a sterile barrier before opening the header bag.  Syringes can be filled easily and efficiently.

 

Each kit provides 36, 1 mL 2-part syringes.  All VitrALA components meet USP Chapter 789 standards for intravitreal injections including for silicone oil and particulates.

 

VitrALA is created using off-the-shelf proved components and meets all FDA requirements. 

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VitrALA meets or exceeds USP Chapter 797 standards, thereby achieving the "non-inferior" guidance.

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Filter integrity verified by bubble test according to institutional protocol.