G21 - Chirurgia spinale - KEYFIX™ jack kyphoplasty mini balloon

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.

G21 - Chirurgia spinale - KEYFIX™ jack kyphoplasty mini balloon

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 15mm and 20mm 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 Mini Balloon codes are:

Code

Description

900027

Winch Kyphoplasty Balloon Catheter 11G Length 15 mm

900028

Winch Kyphoplasty Balloon Catheter 11G Length 20 mm

Certifications:

K172214

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, 15MM – 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, 15MM – 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, 20MM – 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)

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 small diameter, 11G

900097

KEYFIX™ BONE CEMENT FILLER CANNULA small diameter, 11G, (1 pouch composed by 3 pcs)

900100

KEYFIX™ BONE CEMENT FILLER CANNULA small diameter , 11 G, (1 pouch composed by 1 pc)

G21 - Chirurgia spinale - KEYFIX™ traditional access

WINCH KYPHOPLASTY KIT TRADITIONAL ACCESS

The Winch Kyphoplasty Kit Traditional Access is a conversion kit to be used for traditional acces kyphoplasty procedures; it is composed by:

  • Kirschner guide wire (nr. 2 pc);
  • First access needle (13G) with trocar tip (nr. 1 pc);
  • Working cannula (nr. 1 pc).
HOW TO ORDER

The Winch Kyphoplasty Kit Traditional Access code is:

Code

Description

900019

The Winch Kyphoplasty Kit Traditional

G21 - Chirurgia spinale - Biopsy kit

BIOPSY KIT

Biopsy KIT With 3-ml syringe and sampling tube.

HOW TO ORDER

The Biopsy kit code is:

Code

Description

VV 10 190 8

Biopsy kit, where xx indicates the cannula it is compatible with (11 or 13 gauge), and yyy is the length (190 mm).