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ART 21^® Device

The ART 21^® BMC system by Celling Technologies processes autologous bone marrow concentrate effectively and efficiently at point-of-care in less than 15 minutes. The patented cell capturing system was developed to maximize the highest yield of mononucleated cells. The system decreases the potential for tissue contamination by utilizing a closed system design providing a clear pathway between patient and centrifuge.

How it Works:

STEP 1. Fill the ART 21^® BMC with bone marrow aspirate using a syringe and the supplied clot filter. The needleless port protects the sample from contamination.

STEP 2. Place the ART 21^® BMC into a bench top centrifuge and spin at 3200 rpm for 12 minutes to allow for the separation of the bone marrow components and capturing of the buffy coat into the collection chamber.

STEP 3. Remove device from centrifuge and place on processing tray to re-suspend the buffy coat.

STEP 4. Harvest 6-10 mL of stem cell-rich buffy coat. A 12” sterile line is provided to facilitate transfer of sample into the surgical field if required.

ART 21^® System Features:

• Processes bone marrow concentrate at the point-of-care
• Easy to use
• Consistently high yields of mononuclear cells
• Functionally closed
• Less than 15 minutes processing time
• High cell viability
• Low hematocrit
• Packaged for the sterile field
  
  
  

Regulatory

The FDA has determined that the ART 21^® is a LOW RISK, Class I device for which no 510(k) submission is required (i.e. ”Class I Exempt”). The ART 21^® system is also CE marked for use outside of the US.

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