Kyphoplasty systems
AVAflex
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
AVAflex models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| AFB1015 | Length 15 mm; Needle Gauge 10 G | Not stated | Available |
| AFB1020 | Length 20 mm; Needle Gauge 10 G | Not stated | Available |
| AFB1030 | Length 30 mm; Needle Gauge 10 G | Not stated | Available |
| AFB1115 | Length 15 mm; Needle Gauge 11 G | Not stated | Available |
| AFB1120 | Length 20 mm; Needle Gauge 11 G | Not stated | Available |
| AFB1130 | Length 30 mm; Needle Gauge 11 G | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is AVAflex used for?
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Who makes AVAflex?
AVAflex is made by Carefusion 2200, Inc. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does AVAflex come in?
Sizes listed for AVAflex: Length: 15–30 mm; Needle Gauge: 10–11 G. Confirm availability with the manufacturer's instructions for use.
Is AVAflex MRI safe?
The FDA device database entry for AVAflex does not state its MRI safety status. Check the labeling before MRI.
Is AVAflex FDA cleared?
AVAflex is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Carefusion 2200, Inc sales representative?
Carefusion 2200, Inc has not listed representatives on LA Vascular yet. Visit the Carefusion 2200, Inc company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.