Kyphoplasty kit

RENOVA SPINE™ is a minimally invasive system for kyphoplasty procedures to treat fractures, restore vertebral body height and reduce back pain.

Minimally invasive surgery: patient recovers faster;
Fast approach: kyphoplasty procedure with direct percutaneous vertebral access and reduced number of surgical steps;
Percutaneous: less invasive and less traumatic treatment;
Reduced profile of both cannula and balloon catheter;
Cavity creation: minimized risk of cement leakage;
Vertebral body height restoration;
No metallic implants left in situ;
Reduction in morbidity and fast functional recovery;
From lower thoracic to lumbar vertebrae.

A vertebral compression fracture (VCF) occurs when the vertebral body fractures and collapses due to osteoporotic conditions, tumours (e.g. myeloma) or trauma.

The principle of kyphoplasty is to restore vertebral body anatomy gently and progressively by inflating balloons and then reinforcing the anterior column of the vertebra with cement. The balloons create a cavity within the vertebral body, compressing the cancellous bone and thus limiting the risk of cement leakage from the vertebral body.

The balloon catheter is then deflated, and the cavity created is now filled with bone cement, avoiding any leakage.

Surgical technique – FAST APPROACH

Approach & Initial Access

The approach can be extrapedicular or transpedicular.
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.

Creating the Pathway

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.

Balloon Inflation

Connect the balloon catheter to a preloaded inflation system (contrast medium-to-saline ratio: 1:2).
Under fluoroscopic guidance, insert the balloon catheter through the working cannula and position it correctly (AP & lateral view).
Inflate the balloon to the desired volume or maximum measurable pressure, then fully deflate by unscrewing the handle.
Remove the deflated balloon catheter.

Cement Preparation & Injection

While inflating the balloon, begin cement preparation, if necessary.
Load Luer-lock syringes with bone cement and transfer it into a bone filler.
Inject cement through the working cannula, using a plunger for controlled delivery.
Once the cement is placed, remove the bone filler, reinsert the stylet, and carefully extract the working cannula.

TOOLS	SINGLE COMPONENTS CODES	KIT FOR MONOLATERAL APPROACH	KIT FOR BILATERAL APPROACH
RENOVA SPINE™ kyphoplasty working cannula and bevel tip	RESWB1112C	1	1
RENOVA SPINE™ kyphoplasty working cannula and trocar tip	RESWTR1112C	–	1
RENOVA SPINE™ kyphoplasty drill	RESDRI1112C	1	1
RENOVA SPINE™ balloon catheter	10 mm: RESB10PM – RESB10J	1	2
	15 mm: RESB15PM – RESB15J
	20 mm: RESB20PM – RESB20J
RENOVA SPINE™ bone filler	RESFIL1112C1	3	6
Syringes (2,5 ml)	SI02.5L/L-A	4	4
Inflation device: digital or analog	Digital: K05-03069	1	2
Inflation device: digital or analog	Analog: INFLA30	1	2

RENOVA SPINE™ 10G (AVAILABLE ONLY FOR THE USA)

TOOLS	SINGLE COMPONENTS CODES	KIT FOR MONOLATERAL APPROACH
RENOVA SPINE™ kyphoplasty working cannula and bevel/trocar tip	RESWBTR1112C-US	1
RENOVA SPINE™ kyphoplasty drill	RESDRI1112C-US	1
RENOVA SPINE™ balloon catheter	10 mm: RESB10PM – RESB10J	1
	15 mm: RESB15PM – RESB15J
	20 mm: RESB20PM – RESB20J
RENOVA SPINE™ bone filler	RESFIL1112C1-US	3
Syringes (2,5 ml)	SI02.5L/L-A	4
Inflation device: digital	Digital: K05-03069	1