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)
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).
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