August 28, 2021

SYNJECT Cement Delivery System

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Fig 1: Fully assembled SYNJECT Cement Delivery System depicting the dual lineversion of the product. The hydraulic portion can be seen as part of thesystem with the reservoir and the plunger.

The SYNJECT Cement Delivery System (CDS) is a hydraulic-based delivery system for the application of VERTECEM V+ bone cement to augment cancellous bone during vertebral body augmentation (kyphoplasty and vertebroplasty) and received its AO TC approval in 2021.

The design of SYNJECT is directly related to the clinical need to reduce radiation exposure to the surgeon during the cement injection and is allowing remote cement delivery.

Research has proven that spine surgeries, particularly kyphoplasty and vertebroplasty, expose operators to the highest radiation doses [1]. Too much radiation can lead to radiation-related illnesses, such as cataracts, thyroid disease, brain tumors, and brain disease [2–4]. 
To address the impact of high radiation on the health of spine physicians, SYNJECT has been designed with a remote delivery system to reduce radiation exposure from back scattered x-rays [Fig 2 and Fig 3].

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Fig 2:Bi-pedicular remote Cement Delivery with SYNJECT Cement Delivery System.
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Fig 3:Radiation exposure during insertion of Jamshidi cannula [5].

The SYNJECT CDS provides sufficient pressure for the application of high-viscosity PMMA bone cement (VERTECEM V+) in a controlled way due to the hydraulic-based delivery and allows for the immediate stop of cement flow when required. This is effectively attained by releasing pressure on the syringe plunger (tactile feedback).

The system has an optional dual line injection system which is ideal for bi-pedicular cement application. During such procedures, which demand a bigger volume of cement, the ability to rapidly alternate between two injection needles in one device has a significant benefit in terms of time. The tubes and connectors in the SYNJECT dual line injection system are color coded which promotes ease of use and reduces the potential for confusion concerning the cement cartridges. Cement flow ceases during the switch between injection systems which assists with precise application [Fig 4].

During the design validation stage of the SYNJECT CDS, 100% of physicians rated both the pressure and tactile feedback of the system as very good.

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Fig 4: Dualsystem allowing to switch between injection needles. 

References

  1. Efstathopoulos EP, Pantos I, Andreou M, et al. Occupational radiation doses to the extremities and the eyes in interventional radiology and cardiology procedures. Br J Radiol. 2011 Jan;84(997):70-77.
     

  2. Jacob S, Michel M, Spaulding C, et al. Occupational cataracts and lens opacities in interventional cardiology (O'CLOC study): are X-Rays involved? BMC Public Health. 2010 Sep;10:537.
     

  3. Jereczek-Fossa BA, Alterio D, Jassem J, et al. Radiotherapy-induced thyroid disorders. Cancer Treat Rev. 2004 Jun;30:369-84.
     

  4. Roguin A, Goldstein J, Bar O, et al. Brain and Neck Tumors Among Physicians Performing Interventional Procedures. Am J Cardiol. 2013 May;111(9):1368-1372.
     

  5. Lin E, Schueler B. Radiologic issues and radiation safety during ERCP. In: Ercp. 2019:14-29. Amsterdam: Elsevier.

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