Osteoporotic vertebral fractures are usually compression fractures that result in a loss of vertebral body height. These fractures sometimes need to be stabilized, and, in many cases, they can be treated without open surgery, using interventional radiology procedures.
Spine reinforcement with vertebroplasty or kyphoplasty is part of the recommended treatments for symptomatic vertebral fractures.
The main goal of these procedures is the treatment of pain and secondary deformities. Balloon kyphoplasty is intended alleviate pain, stabilize the fracture and restore the loss of height of the vertebral body, correcting and preventing the progression of the kyphotic deformity.
The procedure involves the insertion of one or two inflatable bone buffers (balls) in the vertebrae. Once inflated, the ball creates a cavity, filled with bone cement. It is believed that the creation of this cavity decreases the risk of loss of cement. The effect of the balloon is to create a cavity compressing the trabeculae that provides a solid front capable of moving the vertebral plate.
Fluoroscopy permits direct control of the injection, thanks to the G21 bone cements for vertebral consolidation containing a contrast agent (Zirconium oxide for V-FAST and V-STEADY) that makes they visible.
WINCH KYPHOPLASTY BALLOON CATHETER
The Winch Kyphoplasty Balloon Catheter device is a single-use, coaxial lumen catheter with a balloon placed at the distal tip.
After an initial step of creating access and working cavities, and subsequent placement of the device in the vertebral body, the balloon is inflated, compressing the spongy bone present within the vertebral body and displacing the cortical bone.
This procedure restores the height of the vertebral body, creating a cavity that, once the balloon is removed, deflated, will go to be filled with bone cement, to consolidate its height.
Radiopaque markers are engraved on the inner stem of the balloon, located at the proximal and distal ends of the balloon, allowing fluoroscopic visualization during its placement.
Available in 15 mm and 20 mm lengths. Smaller diameter allows for accurate placement in small vertebral bodies and upper thoracic levels.
Lower pre-inflation profile enables insertion into smaller working cannula (3 mm diameter). Maximum inflation volume: 4 cc.
HOW TO ORDER
The Winch Kyphoplasty Balloon codes are:
Code
Description
900027
Winch Kyphoplasty Balloon Catheter 11G Length 15 mm
900028
Winch Kyphoplasty Balloon Catheter 11G Length 20 mm
Certifications:
FDA Approved
Class I
WINCH KIT FOR DIRECT ACCESS KYPHOPLASTY
The kit includes the instruments (in the small-gauge versions) necessary for performing one kyphoplasty procedure with the direct access method. Integrated, one-step design for quick and efficient percutaneous access to the bone and creation of the channel. No instruments exchange and smaller diameter system allow to effectively reduce the trauma.
The two versions available differ in the size of the balloon included, so that the operator can choose the one most suitable for each individual patient. Direct access needle is available with “bevel” or “trocar” tips to suit physician preference, customizing the treatment approach.
HOW TO ORDER
Code
Description
900016
WINCH KYPHOPLASTY KIT, 15 MM – digital, composed by:
- 900027 WINCH KYPHOPLASTY BALLOON CATHETER Length 15 mm (nr. 1 pc)
- 900103 KEYFIX™ DIRECT ACCESS NEEDLE 10 Gauge, trocar + bevel tip, small diameter (nr. 1 pc)
- 900141 KEYFIX™ BONE DRILL small diameter, 11G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 6 pcs)
- Digital Inflation Device with VacLok syringe(nr. 1 pc)
900016B
WINCH BILATERAL KYPHOPLASTY KIT, 15 MM – digital, composed by:
- 900027 WINCH KYPHOPLASTY BALLOON CATHETER Length 15 mm (nr. 2 pc)
- 900103 KEYFIX™ DIRECT ACCESS NEEDLE 10 Gauge, trocar + bevel tip, small diameter (nr. 2 pc)
- 900141 KEYFIX™ BONE DRILL small diameter, 11G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 6 pcs)
- Digital Inflation Device with VacLok syringe (nr. 2 pc)
900018
WINCH KYPHOPLASTY KIT, 20 MM – digital, composed by:
- 900028 WINCH KYPHOPLASTY BALLOON CATHETER Length 20 mm (nr. 1 pc)
- 900103 KEYFIX™ DIRECT ACCESS NEEDLE 10 Gauge, trocar + bevel tip, small diameter (nr. 1 pc)
- 900141 KEYFIX™ BONE DRILL small diameter, 11G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 3 pcs)
- Digital Inflation Device with VacLok syringe(nr. 1 pc)
900018B
WINCH BILATERAL KYPHOPLASTY KIT, 20MM – digital, composed by:
- 900028 WINCH KYPHOPLASTY BALLOON CATHETER Length 20 mm (nr. 2 pc)
- 900103 KEYFIX™ DIRECT ACCESS NEEDLE 10 Gauge, trocar + bevel tip, small diameter (nr. 2 pc)
- 900141 KEYFIX™ BONE DRILL small diameter, 11G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 6 pcs)
- Digital Inflation Device with VacLok syringe(nr. 2 pc)
900198 Easy Winch, 15 MM
900199 Easy Winch, 20 MM
The kit includes:
- 1 x Winch Kyphoplasty Balloon Catheter 11G (15 MM / 20MM)
- 1 x KeyFix Direct Access Needle 10G cod. 900103
- 1 x G21 Kyphoplasty Digital Inflation Device
Code
Description
900027
WINCH BILATERAL KYPHOPLASTY KIT 8G, 15 MM – digital, composed by:
- 900027 WINCH KYPHOPLASTY BALLOON CATHETER Length 15 mm (nr. 1 pc)
- 900205 KEYFIX™ DIRECT ACCESS NEEDLE 8 Gauge, trocar + bevel tip, small diameter (nr. 1 pc)
- 900206 KEYFIX™ BONE DRILL small diameter, 9G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 6 pcs)
- Digital Inflation Device with VacLok syringe (nr. 1 pc)
900208
WINCH BILATERAL KYPHOPLASTY KIT 8G, 20 MM – digital, composed by:
- 900028 WINCH KYPHOPLASTY BALLOON CATHETER Length 20 mm (nr. 1 pc)
- 900205 KEYFIX™ DIRECT ACCESS NEEDLE 8 Gauge, trocar + bevel tip, small diameter (nr. 1 pc)
- 900206 KEYFIX™ BONE DRILL small diameter, 9G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 6 pcs)
- Digital Inflation Device with VacLok syringe (nr. 1 pc)
900207B
WINCH BILATERAL KYPHOPLASTY KIT 8G, 15 MM – digital, composed by:
- 900027 WINCH KYPHOPLASTY BALLOON CATHETER Length 15 mm (nr. 2 pc)
- 900205 KEYFIX™ DIRECT ACCESS NEEDLE 8 Gauge, trocar + bevel tip, small diameter (nr. 2 pc)
- 900206 KEYFIX™ BONE DRILL small diameter, 9G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 6 pcs)
- Digital Inflation Device with VacLok syringe (nr. 2 pc)
900208B
WINCH BILATERAL KYPHOPLASTY KIT 8G, 20 MM – digital, composed by:
- 900028 WINCH KYPHOPLASTY BALLOON CATHETER Length 20 mm (nr. 2 pc)
- 900205 KEYFIX™ DIRECT ACCESS NEEDLE 8 Gauge, trocar + bevel tip, small diameter (nr. 2 pc
- 900206 KEYFIX™ BONE DRILL small diameter, 9G (nr. 1 pc)
- BONE CEMENT FILLER (nr. 6 pcs)
- Digital Inflation Device with VacLok syringe (nr. 2pc)
For multi-level or bilateral procedures, extra tools can be sold individually:
Code
Description
900027
WINCH KYPHOPLASTY BALLOON CATHETER Length 15 mm
900028
WINCH KYPHOPLASTY BALLOON CATHETER Length 20 mm
900103
KEYFIX™ DIRECT ACCESS NEEDLE 10 Gauge, trocar + bevel tip, small diameter
900141
KEYFIX™ BONE DRILL, 11G
900097
KEYFIX™ BONE CEMENT FILLER CANNULA, 11G, (1 pouch composed by 3 pcs)
900100
KEYFIX™ BONE CEMENT FILLER CANNULA, 11 G, (1 pouch composed by 1 pc)
900205
KEYFIX™ DIRECT ACCESS NEEDLE 8 Gauge, trocar + bevel tip, small diameter
900206
KEYFIX™ BONE DRILL small diameter, 9G
KEYFIX™ BONE CEMENT FILLER CANNULA FOR SCREW CEMENTATION
The KEYFIX™ Bone cement filler cannula (diameter 1,7 mm) is used for the pedicle screw cementation.
HOW TO ORDER
The KEYFIX™ Bone cement filler cannula code is:
Code
Description
900146
KEYFIX™ Bone cement filler cannula
Certifications:
FDA Approved
Class I
BIOPSY KIT
Biopsy KIT With 5-ml syringe and sampling tube.
HOW TO ORDER
The Biopsy kit code is:
Code
Description
VV 10 190 8
Biopsy kit, dedicated to 10 gauge cannulas, 190 is the length (190 mm).
VV 11 190 8
Biopsy kit, dedicated to 11 gauge cannulas, 190 is the length (190 mm).
VV 13 190 8
Biopsy kit, dedicated to 13 gauge cannulas, 190 is the length (190 mm).
Certifications:
FDA Approved
Class I
FLEX DRILL 13G
A flexible drill made of medical grade nitinol that can be used to create a cavity suitable for the kyphoplasty balloon catheter in the vertebra.
HOW TO ORDER
The Flex Drill 13G code is:
Code
Description
900187
Flex Drill 13G
Certifications:
FDA Approved
Class I