G21 - Chirurgia spinale - KEYFIX™ jack kyphoplasty mini balloon

Osteoporosis and metastasis may weaken the vertebrae to such a point that they fracture by effect of the compression generated by normal everyday activities, causing pain and difficulty of movement in the patients.
Compared to vertebroplasty, which is aimed solely at symptomatic treatment of pain, kyphoplasty also encourages restoring the height of the vertebral body. This is a minimally invasive percutaneous procedure whereby a balloon catheter is inserted into the vertebra to be treated through a channel created with a small-gauge cannula. The balloon is then filled with liquid containing the contrast medium in order to create a cavity and restore the height of the collapsed vertebral body, bringing it back to its natural position. After removing the balloon, the same cannula is used to inject a specific cement into the cavity, in order to stabilize and consolidate the shape of the vertebra.

The Winch™ series includes the instruments necessary for execution of the kyphoplasty procedure with both the conventional and the direct access method, also in the small-gauge versions. It is recommended to use them in combination with G21’s bone cements for vertebral consolidation.

G21 - Chirurgia spinale - KEYFIX™ jack kyphoplasty mini balloon

WINCH KYPHOPLASTY BALLOON CATHETER

Inflation of the kyphoplasty balloon creates a cavity and compacts cancellous bone in the vertebral body for delivering bone cement. Low pre-inflation profile allows for accurate placement inside the vertebral body through smaller diameter cannulas. High quality manufacturing, range of shapes and sizes to fit patient anatomy. Radiopaque markers allow for accurate visualization during positioning prior to inflation with contrast medium.

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:

FDA 510(k): 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. 3 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

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, size 10, and length 190 mm.

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