RENOVA SPINE™ 11G:
kyphoplasty kit for fast approach
RENOVA SPINE™ 8G:
kyphoplasty kit for classic approach
Spine Surgery Procedures
KYPHOPLASTY
A vertebral compression fracture (VCF) occurs when a vertebral body collapses due to osteoporosis, trauma, or tumors such as multiple myeloma.
Kyphoplasty aims to gently and progressively restore vertebral height by inflating balloons within the vertebral body. This process creates a cavity by compacting the cancellous bone, which helps minimize the risk of cement leakage. Once the balloons are deflated and removed, the cavity is filled with bone cement to stabilize the fracture.
RENOVA SPINE™ is a minimally invasive system designed for kyphoplasty procedures. It helps treat vertebral fractures, restore vertebral height, and relieve back pain. The system facilitates cavity creation in the spongy bone and is intended for use with a legally marketed bone void filler suitable for vertebroplasty or vertebral augmentation.
Two access options are available:
Working cannula with trocar or bevel tip: enables direct percutaneous access with fewer surgical steps; included in the RENOVA SPINE™ 11G and 13G Kyphoplasty kits.
Guidewire access: guides the introduction of instruments; included in the RENOVA SPINE™ 8G Kyphoplasty kit.
Indications
• Painful vertebral compression fractures
• Osteolytic lesions within the vertebral body
Kyphoplasty benefits
- Minimally invasive
- Percutaneous access
- Cavity creation
- Vertebral height restoration and conservation
- No metallic implant left in place
- Reduced morbidity
- Faster recovery times
- Less invasive and traumatic, with reduced muscle and soft tissue damage
- Lower risk of cement leakage due to bone compaction acting as a natural barrier; high-viscosity cement can be used
- Improved spinal alignment and vertebral height restoration
- Better long-term outcomes by preserving the patient’s natural anatomy, reducing the risk of adjacent-level fractures and associated complications
- Greater flexibility and simpler technique compared to metallic implant placement
- Proven pain relief and rapid functional improvement
surgical procedure (Fast)
It is possible to perform a transpedicular or extrapedicular access, depending on the anatomy of the vertebral body to be treated.
1.
Access creation
Under fluoroscopy, insert the fast-working cannula into the vertebral body until firmly placed (~3mm depth).
Hold the cannula in place, remove the stylet, and leave the working cannula in position.
2.
CAVITY PREPARATION
Insert the drill through the working cannula and into the vertebral body.
Rotate 180° clockwise and counterclockwise to create a pathway for the balloon, then remove the drill.
3.
INFLATION DEVICE SETUP
Connect the balloon catheter to a preloaded inflation system (contrast medium-to-saline ratio: 1:2).
4.
BALLOON POSITIONING
Under fluoroscopic guidance, insert the balloon catheter through the working cannula and position it correctly (AP & lateral view).
5.
BALLOON INFLATION
Inflate the balloon to the desired volume or maximum measurable pressure, then fully deflate by unscrewing the handle of the inflating device.
Remove the deflated balloon catheter.
6.
cement injection
Load Luer-lock syringes with bone cement and transfer it into a bone filler. Inject cement through the working cannula, using the plunger for controlled delivery. Once the cement is placed, remove the bone filler, reinsert the stylet, and carefully extract the working cannula.
video library
RENOVA SPINE™ 11G:
RENOVA SPINE™ 8G:
