ICELLATOR®

CELL ISOLATION CARTRIDGE KIT

Cartridge Kit

THE ICELLATOR® CARTRIDGE KIT BENEFITS

UNIQUE INTEGRATED DIGESTION, WASHING AND RESUSPENSION CENTRIFUGE CHAMBER
  • Injection port for addition of adipose tissue.
  • Delivers final cell product to integrated syringe for immediate use.
  • Sterile end-to-end cell isolation path.
  • Proprietary Adipase® enzyme enables the highest possible yield of viable cells per ml of lipoaspirate.
  • Automated addition of Adipase® enzyme for temperature-controlled tissue and separation process leads to efficient SVF isolation1.
1. Joel A. Aronowitz, Ryan A. Lockhart, Cloe S. Hakakian (2015), Mechanical versus enzymatic isolation of stromal vascular fraction cells from adipose tissue: 4:713 DOI 10.1186/s40064-015-1509-2

HIGHLIGHTS

  • Sterile, single-use disposable cartridge using adipose tissue for high efficiency enzyme derived SVF isolation with Icellator.
  • Functionally closed system.
  • Minimizes process and cell product variability.
  • Temperature controlled digestion and separation.
  • Class III approval for commercial use by the South Korean Ministry of Food and Drug Safety (MFDS).
  • Approved for clinical use in The Bahamas.
  • In the USA, FDA-approved clinical IDE studies using the Icellator® and Cell Isolation Cartridge are underway for multiple indications.
  • Produced under ISO 13485 according to 21 CFR 820 (GMP).

INSTRUMENT OPERATION

  • The Icellator® is designed for maximum use simplicity by clinical staff.

Instrument Operation

DELIVERS CELL PRODUCT READY FOR USE

  • Delivers cell product into a 60 mL syringe ready for immediate use.
  • Minimizes sterile breaks and opportunity for contamination.
  • Once loaded with a replacement cartridge kit, the Icellator® is immediately ready for the next patient’s sample.

DESIGN AND AUTOMATION

  • Gamma-irradiated, sterile polycarbonate cell separation and centrifugation chamber with double wall construction and optimized separation geometry.
  • Transparent construction for real-time observation.
  • Precision stainless cannulas for filling and aspiration.
  • Luer injection port and cap for lipoaspirate loading.
  • Motion Industries® precision high-rpm load bearing and nitrile pneumatic seal with resistive torque arm.
  • Sterile fluid control polyallomer matrix assembly for controlling liquid flow during automated processing.
  • Platinum silicon tubing assembly, Versapor® vents and custom solids filtration.
  • Sterile ethylene vinyl acetate solution reservoir for wash buffer.
  • 30 mL amber glass vial, aseptically-filled with lyophilized Adipase® custom formulated for the digestion of adipose tissue.

STERILE FLOW PATH SINGLE-USE PLASTIC CARTRIDGE KIT

  • Produced under ISO 13485 and according to 21 CFR 820 (GMP).
  • Manufactured in an ISO 7 Cleanroom.
  • Sterilized by gamma irradiation.
  • Nonpyrogenic.

FOR MORE INFORMATION

Email: info@tissuegenesis.com

Phone: (844) 991-3999

© Copyright 2017 Tissue Genesis, LLC. All rights reserved. “Tissue Genesis”, “Tissue Genesis Icellator Cell Isolation System”, ”Icellator” and “Adipase” are all registered trademarks of Tissue Genesis, LLC. Product images and descriptions contained herein are for informational purposes only. The information contained herein is subject to change without notice. Tissue Genesis, LLC shall not be liable for errors contained herein for consequential damages in connection with the furnishing, performance, or use hereof.

CAUTION: Investigational device. Limited by law in the United States to investigational use.

Adipase®