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StabiliT
®
Augmentation System
with PowerCURVE
Navigating Osteotome
(For use with StabiliT
Important Information – Please Read Before Use
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.
INDICATIONS
The StabiliT® MX Vertebral Augmentation System is intended for percutaneous delivery of StabiliT Bone Cement.
The StabiliT Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a
vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis,
benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
DESCRIPTION
The StabiliT MX Vertebral Augmentation System is a system for the controlled delivery of StabiliT Bone Cement
in the treatment of vertebral compression fractures. The StabiliT MX Vertebral Augmentation System consists of
different combinations of the components below (Figure 1).
2. Master Syringe and
Hydraulic Coupler
3. Cement
Delivery Elbow
7e. Locking Syringe
StabiliT Introducers
6. Locking Delivery Cannula with Locking Wheel
MX Vertebral
INSTRUCTIONS FOR USE
Working Length
Working Length
Working Length
8. PowerCURVE Navigating Osteotome
Working Length
9. StraightLine Osteotome
Figure 1: StabiliT MX Vertebral Augmentation System
®
Bone Cement)
®
7a. Funnel
7b. Cement Syringe
7c. Filter
7d. Stopcock
4. & 5.
7f. Monomer
1. DiamondTOUCH™ Syringe
English
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Related Manuals for Merit Medical StabiliT MX
Summary of Contents for Merit Medical StabiliT MX
- Page 1 (hemangioma), and malignant lesions (metastatic cancers, myeloma). DESCRIPTION The StabiliT MX Vertebral Augmentation System is a system for the controlled delivery of StabiliT Bone Cement in the treatment of vertebral compression fractures. The StabiliT MX Vertebral Augmentation System consists of different combinations of the components below (Figure 1).
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Page 2: How Supplied
Thoroughly read the IFUs for each device including the StabiliT Bone Cement and Saturate Mixing System, (if packaged separately or along with this IFU) before use. The IFU must be followed to perform a procedure using the StabiliT MX Vertebral Augmentation System. •... -
Page 3: Adverse Events
• Dispose of used product per local, state and federal blood borne pathogen controls including biohazard sharps container and disposal procedures. • DO NOT use if package is opened or damaged. All devices are provided sterile. All devices are sterilized using gamma radiation. - Page 4 Optional device stickers are included to be attached to the DiamondTOUCH Syringe to identify the fluid being used in the syringe. The white sticker may be used to identify sterile water, the blue sticker for saline, and the yellow sticker for contrast (contrast not associated with the StabiliT MX Vertebral Augmentation System).
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Page 5: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
• When the Articulating Tip is substantially deployed, the PowerCURVE should not be rotated. 1. The rotation limiting mechanism will slip if the large handle is rotated while the Articulating Tip is substantially articulated in dense bone. Caution: The location of the Working Cannula in the vertebra should be monitored before, and during advancement of the PowerCURVE through the Working Cannula. -
Page 6: Storage And Handling
For the State of California, U.S.A. only Perchlorate Material: special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate Perchlorate Material: Lithium battery contains perchlorate. www.merit.com Manufacturer: Merit Medical Systems, Inc. 1600 West Merit Parkway, South Jordan, Utah 84095 U.S.A. 1-801-253-1600 U.S.A Customer Service 1-800-356-3748 Authorized Representative:...
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