18/08/2014
AO Technical Commission Approved

Synflate Vertebral Balloon System

Synflate is a vertebral augmentation system for the reduction of fractures and/or creation of voids in cancellous bone. It provides pain reduction in vertebral compression fractures originating from osteoporosis, trauma, and osteolytic lesions.

Some of the vertebral augmentation techniques currently available include:

  • Vertebroplasty (eg, cement injection of Vertecem V+ or Confidence
  • Spinal Cement System for pain treatment)
  • Stentoplasty (Vertebral Body Stent (VBS) for pain treatment, cavity
  • creation, and stent-supported height restoration)
  • Kyphoplasty
  • Lordoplasty

Synflate can be used stand-alone or in combination with posterior instrumentation (see the clinical cases within this article).

The Synflate system (Fig 1) allows accessing the vertebral body percutaneously with a 10 gauge needle and offers 3 standard sizes of balloons (small/medium/large = 10/15/20 mm). Access options include trocar (diamond and beveled) or wire guide access over cannulated trocar.

Both guide wire and trocar can be inserted through either a transpedicular (Fig 2a) or extrapedicular (Fig 2b) approach. The trocar allows access in a single step while the wire guide is first used to create a path for the access instruments.

The Synflate Vertebral Balloon Catheter is designed on a double lumen principle. This includes the inner lumen with the stiffening wire (Fig 3, 1) and the outer lumen (Fig 3, 2) which delivers the inflation medium to the balloon. Both lumens are independent, and therefore it is the surgeon's choice to remove the stiffening wire during inflation.

The inflation system has an angled manometer that shows the pressure (Fig 4, 1) in the balloon in pounds/inch (psi) and bar. The volume scale (Fig 4, 2) on the fluid chamber displays milliliters (ml) (Fig 4). It is necessary to prepare one inflation system per balloon and to fill it with a mixture of saline solution and liquid contrast medium.

The optimized balloon stiffness allows for well controlled inflation and optimized lifting efficacy, reducing the risk of the balloon following the path of least resistance. Moreover, 2 radiopaque markers help in the x-ray visualization of the balloon to facilitate accurate placement (Fig 5).

The controlled inflation of the balloons allows you to reduce the fracture and create a cavity in the cancellous bone. This containment can subsequently be filled using a legally-marketed bone filler adequately indicated for kyphoplasty and/or vertebroplasty procedures, to stabilize fractures in the vertebral body, prevent further collapse of the vertebra, and to reduce pain (Fig 6). The direction of the bone filler flow can be changed by orienteering the handle of the injection needle with the side opening.

The main contraindications for Synflate are:

  • Stand-alone use with neurological deficits
  • Stand-alone use with instability of posterior wall and/or pedicles
  • Lesions requiring open anterior column reconstruction
  • If vertebral dimensions or fracture pattern do not allow safe placement
  • and inflation of the balloon
  • Acute and chronic systemic or localized spinal infections
  • Known allergies to contrast media.

Case 1: Steroid induced osteoporosis

(Case provided by Lorin Benneker, Bern, Switzerland)

A 78-year-old woman was affected by steroid induced osteoporosis. She had persisting pain (mechanic and muscular) due to static imbalance (hyperkyphosis) and nonunion 8 months after a minor trauma with a vertebral compression fracture and vertebra plana of L1, and development of symptomatic stenosis of the spinal canal with loss of mobility over time. Pre-existing degenerative lumbar scoliosis was increased by the fracture.


Case 2: Advanced osteoporosis

(Case provided by Lorin Benneker, Bern, Switzerland)

A 76-year-old man was affected by advanced osteoporosis (SD -2.5) (alcohol, steroids).

 

Hazards and labeling

Due to varying countries’ legal and regulatory approval requirements, consult the appropriate local product labeling for approved intended use of the products described on this website. All devices on this website are approved by the AO Technical Commission. For logistical reasons, these devices may not be available in all countries worldwide at the date of publication. 


Legal restrictions

This work was produced by AO Foundation, Switzerland. All rights reserved by AO Foundation. This publication, including all parts thereof, is legally protected by copyright.

Any use, exploitation or commercialization outside the narrow limits set forth by copyright legislation and the restrictions on use laid out below, without the publisher‘s consent, is illegal and liable to prosecution. This applies in particular to photostat reproduction, copying, scanning or duplication of any kind, translation, preparation of microfilms, electronic data processing, and storage such as making this publication available on Intranet or Internet.

Some of the products, names, instruments, treatments, logos, designs, etc referred to in this publication are also protected by patents, trademarks or by other intellectual property protection laws (eg, “AO” and the AO logo are subject to trademark applications/registrations) even though specific reference to this fact is not always made in the text. Therefore, the appearance of a name, instrument, etc without designation as proprietary is not to be construed as a representation by the publisher that it is in the public domain.

Restrictions on use: The rightful owner of an authorized copy of this work may use it for educational and research purposes only. Single images or illustrations may be copied for research or educational purposes only. The images or illustrations may not be altered in any way and need to carry the following statement of origin “Copyright by AO Foundation, Switzerland”.

Check www.aofoundation.org/disclaimer for more information.

 

If you have any comments or questions on the articles or the new devices, please do not hesitate to contact us


"approved by AO Technical Commission" and "approved by AO Foundation"

The brands and labels "approved by AO Technical Commission" and "approved by AO Foundation", particularly "AO" and the AO logo, are AO Foundation's intellectual property and subject to trademark applications and registrations, respectively. The use of these brands and labels is regulated by licensing agreements between AO Foundation and the producers of innovation products obliged to use such labels to declare the products as AO Technical Commission or AO Foundation approved solutions. Any unauthorized or inadequate use of these trademarks may be subject to legal action.

2020 IM covers

AO TC Innovations Magazine

Find all previous issues of the AO TC Innovations Magazine for download here.

Meet the Experts

Directly learn about AO Approved Solutions from the Experts themselves.

Innovation Awards

Innovation awards

Recognizing and fostering excellence in surgical innovation.

X
Cookies help us improve your website experience.
By using our website, you agree to our use of cookies.
Confirm