1

 

proxicor

 

ProxiCorTM for Pericardial Closure enables surgeons to re-establish the essential native anatomic structure of the pericardium.

ProxiCor for Pericardial Closure is used to restore the pericardium by providing a natural bioscaffold that allows the patient’s own cells to form a new pericardial layer.1,2 Absence of the pericardial barrier often leads to scarring and the formation of adhesions between the heart and sternum, impairing normal heart function.1,3,4,5,6 Reconstructing the pericardium facilitates less bleeding and re-exploration, safer re-entry, and may shorten operative times for redo.4,7,8 Reformation of the pericardium using ECM enables surgeons to re-establish this essential native anatomic structure.1

Benefits:

  • Remodels over time to restore healthy, pericardial tissue1
  • Preserves the distance between the heart and sternum4
  • May shorten operative times for redo procedures9
  • Enables accurate identification of post-operative bleeding10
  • Lacks the pro-inflammatory components of chemically fixed xenografts3
  • May improve hemodynamics by restoring normal anatomy11

 

REFERENCES

 

  1. Stelly M et al.Ann Thorac Surg. 2013 Nov;96(5):e127-9.
  2. Sundermann S et al. Thorac Cardiovasc Surg. 2014 Feb;62(1):76-9.
  3. Boyd W et al. Expert Rev Cardiovasc Ther. 2012 Sep;10(9):1109-18.
  4. Rao V et al. Should the pericardium be closed routinely after heart operations?. Ann. Thorac. Surg. 67(2), 484–488 (1999).
  5. Bittar M et al. Interact Cardiovasc Thorac Surg. 2005 Apr;4(2):151-5.
  6. Morales D et al. Interact Cardiovasc Thorac Surg. 2010 Sep;11(3):277-86.
  7. Bahn C et al. Pericardial Closure. Am J Surg. 1986 May;151(5):612-5.
  8. Rego A et al. Presented at ACC 2017 Scientific Sessions.
  9. Singh T et al. The Internet Journal of Thoracic and Cardiovascular Surgery. 2007 Volume 12 Number 2.
  10. Spodick. Intrapericardial Therapy and Diagnosis. Curr Cardiol Rep. 2002 Jan;4(1):22-5.
  11. Kroeker C et al. Am J Physiol Heart Circ Physiol. 2003 Jun;284(6):H2247-54.

 

 

   

 2

ECM is our next-generation tool for repair of intracardiac structures. Regrowth and remodeling capabilities make it superior to inert patches that ultimately promote inflammation and scarring.

ProxiCorTM for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue repair (i.e. atrial septal defect [ASD], ventricular septal defect [VSD], etc.) and suture-line buttressing.  It may be used to repair intracardiac tissues, damaged cardiac structures, or during procedures when cardiovascular prosthetics (such as valves) do not fit properly. ECM is ideal for intracardiac surgery based on its ability to structurally support repairs and remodel tissue. In cases such as ASD repair, ProxiCor for Cardiac Tissue Repair can effectively close a hole and generate new, healthy tissue in lieu of using objects such as nitinol plugs or synthetic patches. ECM is gradually replaced by native tissue as it remodels.

Benefits:

  • Effectively closes holes and restores natural cardiac tissue
  • Ideal for intracardiac repairs
  • Encourages the body’s natural immune response, unlike synthetic grafts1,2
  • Allows capillary in-growth and infiltration3,4,5,6
  • Resists calcification7,8,9,10

 

REFERENCES

  1. Piterina A et al. Int J Mol Sci. 2009 Nov 20;10(10):4375-417.
  2. Additional references on file
  3. Shell D et al. Ann Surg. 2005 Jun;241(6):995-1001; discussion 1001-4.
  4. Sundermann S et al. Interact Cardiovasc Thorac Surg. 2015 Jan;20(1):10-4.
  5. Li F et al. Endothelium. 2004 May-Aug;11(3-4):199-206.
  6. Badylak S et al. J Surg Res. 2002 Apr;103(2):190-202.
  7. Sundermann S et al. Thorac Cardiovasc Surg. 2014 Feb;62(1):76-9.
  8. Fallon A et al. J Surg Res. 2012 Jun 1;175(1):e25-34.
  9. Gerdisch M et al. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1370-8.
  10. Padalino M et al. Interact Cardiovasc Thorac Surg. 2015 Jul;21(1):40-9; discussion 49.

 

Ideal Uses for ProxiCor for Cardiac Tissue Repair:

  • ASD Repair
  • VSD Repair
  • Aortic Root Enlargement
  • Left Ventricular Aneurysm Repair
  • Sinus of Valsalva Aneurysm
  • Repair of Cardiac Tumors
  • Endocarditis
  • Use as a Pledget
  • Suture-Line Buttressing