Synflate Vertebral Balloon System

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Synflate Vertebral Balloon System

Lorin Benneker, Frank Kandziora

Fig 1 Synflate system: main surgical procedure phases.

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).

Details
Clinical Cases
Disclaimer

The Synflate system (Fig 1) allows access to 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.

Fig 2 a Transpedicular insertion. b Extrapedicular insertion.

Fig 3 Synflate Vertebral Balloon Catheter

Fig 4 Inflation system

Fig 5 Balloon inflation

Fig 6a Bone Filler injection

Fig 6b Three stage bone segment injection

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.

Fig 7 Standing preoperative lateral x-ray, kyphotic deformity of 34.

Fig 8 Standing preoperative AP x-ray, scoliotic deformity of 25 (T12- L4).

Fig 9 The MRI shows severe spinal canal stenosis at conus level and nonunion of the fracture (fluid within the cleft)

Fig 10 The CT shows partial realignment in supine position

Fig 11 Intraoperative lateral fluoroscopy: reduction of the fracture by simultaneous application of balloon dilatation and the use of percutaneous, monoaxial dorsal instrumentation (after minimal invasive decompression at T12-L1).

Fig 12 Intraoperative AP fluoroscopy after filling of the defect with PMMA (Vertecem+)

Fig 13 Intraoperative lateral fluoroscopy after filling of the defect, with augmention of the screws and prophylactic vertebroplasty of adjacent levels with PMMA (Vertecem+)

Fig 14 Postoperative standing lateral x-ray, correction of kyphotic deformity from 34 to 8

Fig 15 Postoperative standing AP x-ray, correction of scoliotic deformity from 25 to 19

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).

Fig 16 Nontraumatic VCFx of L1 with progressive collapse and pain

Fig 17ab Prophylactic augmentation of adjacent vertebrae with PMMA. Preparation for balloon placement

Fig 18ab Reduction by inflation of Synflate and lordoplasty

Fig 19ab Postoperative standing x-rays

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