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Today's "State of the Art"

60+ years of Open-Heart Surgery

Since 1957, when Dr. Ormand Julian described the first open-heart surgery, surgeons have traditionally closed the chest wall routinely the same way with twisting stainless steel wire around the sternum to secure the chest wall.

 

CircumFix is going to change that forever.

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  • Sternal cerclage wire - since the beginning of bisecting the chest wall, twisted metal wire that is looped around sternum to secure it.

  • Metal plates and screws - in the early 2000's orthopedic companies began promoting the use of fixed angle closures to repair the chest wall.

  • Orthopedic cable- A metal braided material that "cinches" together bone.

  • Combining technologies - often surgeons select to use multiple closure systems and techniques to compensate for poor bone quality or co-morbidities. 

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Complication rates with current sternal closure technologies: 

 

  • Deep sternal wound infection (DSWI)- (0.6–5%) 4

  • Sternal dehiscence (SD)- (0.5-8.4%) 3

  • Delayed healing (sternal non-union)-  (0.5 to 3%)5

  • Post-operative sternal pain (PSPS)- (7%–66%) 6

  • Reduced patient mobility

 

The leading cause of post-operative complication following a sternotomy is sternal instability.

  

3. Sternal Dehiscence Reconstruction,https://emedicine.medscape.com/article/1278627-overview 

Mark A Grevious, MD, FACS Chairman, Division of Plastic and Reconstructive Surgery, John H Stroger, Jr Hospital of Cook County

4. Deep sternal wound infection after cardiac surgery: a comparison of three different wound infection types and an analysis of antibiotic resistance, J Thorac Dis. 2018 Jan; 10(1): 377–387. Jia-Gui Ma and Jian-Xiong

5. Late Complications of Chest Wall Reconstruction: Management of Painful Sternal Nonunion , Semin Plast Surg. 2011 Feb; 25(1): 98–106. Kyle J. Chepla, M.D.,1 Christopher J. Salgado, M.D.,2 Cathy J. Tang, M.D., M.S.,3 Samir Mardini, M.D.,4 and Karen K. Evans, M.D.5

6. Post-sternotomy pain syndrome following cardiac surgery. J Pain Res. 2017; 10: 1163–1169. Bruno Bordoni,1 Fabiola Marelli,2,3 Bruno Morabito,2,3 Beatrice Sacconi,4,5 and Paolo Severino6​

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The Future 'Standard of Care'

The VariTrax Sternal Circumfixator is a proprietary sternal repair and healing solution for patients who undergo sternotomy, based on proven bone healing principles, addressing the specific needs of patients, care providers, health institutions and payers. 

 

  • High-performance implant grade polymers provide optimal biocompatibility, fatigue properties, radiolucency and a reduced risk of infection.

  • Superior biomechanics - Circumfixators precisely control and distribute dynamic forces acting on the sternum while maintaining anatomical alignment.

  • Reducing motion reduces pain. Circumfixators arrest movement of sternum helping patients recover faster with less post-op pain, leading to earlier rehabilitation and return to normal activity. 

  • Circumfixators are quickly, easily and consistently applied, facilitating safe and reliable outcomes for all patients.

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