The world’s first anatomically designed aortic root graft 1

The GelweaveTM Valsalva Sinus Design

  • 15 year proven clinical success 5
  • Closely matches aortic root anatomy 1
  • Effectively mimics 2 and generates 3  the independent sinuses of Valsalva 6
  • More physiological valve motion than standard straight grafts 3
  • Provides the potential to reduce tension on the coronary anastomoses 3
  • Potential for increased valve longevity 7

Mimics native sinuses of Valsalva 2

Physiological valve motion and flow pattern 2

Gelweave™ technology with excellent handling 4

GelweaveTM Valsalva procedure videos

Aortic Valve Opening and Closing Characteristics
Visual evidence of the importance of sinuses of valsalva after a reimplantation type of valve sparing procedure using a new aortic root conduit. 

Procedure performed by
Ruggero De Paulis
in collaboration with: 
Raffaele Scaffa, Luigi ChiarielloWim Morshius, Marc Schepens and Gerda L. van Rijk-Zwikker

David I Clinical Reimplantation Procedure
Professor Roberto Di Bartolomeo
 
Professor Rugerro De Paulis
 

Bentall Procedure with a Bovine Pericardial Bioprosthesis
Professor Rugerro De Paulis

 

Bentall Procedure with a Stentless Porcine Bioprosthesis
Professor Roberto Di Bartolomeo
 
 

Key Benefits of the GelweaveTM Valsalva Graft

The GelweaveTM Valsalva Sinus Design

  • Allows a space to be created between stented valve struts and the graft wall minimising the potential of coronary button complications 9
  • Provides the potential to reduce tension on the coronary buttons 9,10
  • Reduces the risk of leaflet contact with the graft wall during systole 10
  • Potential for increased valve longevity 10

Biological Bentall Procedures

Maintain natural flow patterns

The graft enables stentless and stented biological valve conduits to be created9,10 resulting in a more physiological flow pattern2

Valve-Sparing Reimplantation

Reimplantation with the GelweaveTM Valsalva graft maintains annular stability8

The sinotubular junction and sinuses of Valsalva are crucial for the normal functioning of the valve1

  1. Long axis view of the aortic root during systole showing sinus geometry and space between the valve leaflets and graft wall. (LV = left ventricle, S = sinus, Ao = aorta)
     
  2. Short axis view of the sinus region during diastole illustrating the presence of 3 discrete sinuses (S). 

Images courtesy of Professor Ruggero De Paulis 

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Features a 15 year clinical history 5

IFU available in 20 languages

The ability of the [GelweaveTM ] Valsalva graft to provide independent sinuses of normal shape and dimension makes the reimplantation procedure applicable to virtually every patient. This, in turn, will result in improved standardisation and greater reproducibility of the results.6 

Professor Ruggero De Paulis

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Instructions for Use

References

  1. De Paulis R, et al. A New Aortic Dacron Conduit for Surgical Treatment of Aortic Root Pathology. Ital Heart J, 2000, 7, 457-463.
  2. Schoenhoff FS, et al. The Role of the Sinuses of Valsalva in Aortic Root Flow Dynamics and Aortic Root Surgery: Evaluation by Magnetic Resonance Imaging. J Heart Valve Dis, 2009, 18, 380-385
  3. De Paulis R et al. One-year Appraisal of a New Aortic Root Conduit with Sinuses of Valsalva. J Thorac Cardiovasc Surg. 2002 Jan;123(1):33-9.
  4. Data on file at Vascutek Ltd.
  5. De Paulis R et al. Long Term Results of the Valve Reimplantation Technique using a Graft with Sinuses. J Thorac Cardiovasc S urg. 2015. 1-8.
  6. De Paulis R, et al. Use of the Valsalva Graft and Long-term Follow Up. J Thorac Cardiovasc Surg. 2010 Dec;140(6S):23-29.
  7. De Paulis R, et al. Analysis of Valve Motion After the Reimplantation Type of Valve-Sparing Procedure (David 1) with a New Aortic Root Conduit. Ann Thorac Surg, 2002, 74, 53-57.
  8. Patel, et al. Valve-sparing Aortic Root Replacement: Early Experience with the De Paulis Valsalva Graft in 51 patients. Ann Thorac Surg 2006; 82:548-553.
  9. Tabata M, et al. Modified Bentall Operation with Bioprosthetic Valved Conduit: Columbia University Experience. Ann Thorac Surg, 2009, 87, 1969-1970.
  10. Stewart AS, et al. Modified Bentall Operation with a Novel Biologic Valved Conduit. Ann Thorac Surg, 2010, 89, 938–942.

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