A Terumo Group Website
Gelweave™ Aortic Root Designs

Product Information

Gelweave Valsalva™

Gelweave Valsalva

Gelweave Valsalva™, the world’s first aortic root graft. It is used in valve sparing or combined prosthetic valve implant procedures.

Product Details

Gelweave Valsalva™ is the world's first custom designed aortic root graft that is indicated for repair and replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation. It is used in valve sparing or combined prosthetic valve implant techniques.

Gelweave Valsalva

Gelweave Valsalva™ consists of 3 sections, a body, skirt and collar. This unique design,

  • Closely matches the aortic root anatomy16
  • Mimics the natural response of the sinuses of Valsalva™16
  • Reduces the tension on the coronary anastomoses17
  • Has the potential to increase the lifespan of the natural valve18
Gelweave Heart Clinical Implant

Graft Clinical Implant
David I Reimplantation Technique
Picture courtesy of Professor Duke Cameron,
John Hopkins Hospital, Baltimore, USA.
Graft Placement
David I Reimplantation Technique

Studies have shown that Gelweave Valsalva™,

  • Exhibits superior aortic valve leaflet opening and closing compared to standard tube grafts, more similar to healthy individuals16,18
  • Due to the presence of the pseudosinuses, created by the “skirt” and the well defined sinotubular junction, facilitates near normal valve leaflet motion with the potential for prolonged valve leaflet longevity18,19
  • May decrease the incidence of  postoperative complications such as bleeding or late pseudoaneurysm formation17

Please click below to view or download the implant technique information sheets (.pdf)

Please click below to view or download the Gelweave Valsalva™ Reimplantation Technique booklet.

References (Click to expand)

    1. Jenkinson P
      Thrombogenicity of Coated Medical Products
      Safepharm Laboratories Ltd, UK. 1989
    2. Drury J. et al. (1987)
      Experimental and Clinical Experience with a Gelatin Impregnated Dacron Prosthesis
      Ann Vasc Surg,1, 542-547
    3. Rinsing of Gelatin Sealed Prostheses with Rifampicin and Heparin BSI EQ# 1002097.
    4. Hayes P.D. et al. (1999)
      In situ Replacement of Infected Aortic Grafts with Rifampicin-bonded Prostheses: The Leicester Experience (1992 to 1998)
      J Vasc Surg, 30, 92-98
    5. Vicaretti M. et al. (1998)
      An Increased Concentration of Rifampicin Bonded to Gelatin-Sealed Dacron Reduces the Incidence of Subsequent Graft Infections Following a Staphylococcal challenge
      Cardiovasc Surg, 6, 3, 268-273
    6. Havel M. et al. (1994)
      Operative Management of Aortic Arch Aneurysm Using Profound Hypothermia and Circulatory Arrest. International Congress on "Thoracic and Thoracoabdominal Aortic Aneurysm" Innsbruck
      Austria 12-14th June
    7. Ehrlich M. et al. (1997)
      The Use of Profound Hypothermia and Circulatory Arrest in Operations on the Thoracic Aorta
      European Journal of Cardiothoracic Surgery, 11, 176-181
    8. Shiiya N. et al. (2001)
      Surgical Management of Atherosclerotic Aortic Arch Aneurysms Using Selective Cerebral Perfusion: 7 Year Experience in 72 Patients
      European Journal of Cardiothoracic Surgery, 71, 266-271
    9. Adachi H. et al. (1997)
      Usefulness of New Branched Sealed Graft for the Replacement of Aortic Arch
      Japanese Journal for Artificial Organs, Vol 26, No 3: pp624-628
    10. Neri E. et al. (2004)
      The "Elephant Trunk" Technique Made Easier
      Ann Thorac Surg, 78:e17-8
    11. Neri E. Personal Communication November 2008
    12. Spielvogel D. et al. (2003)
      Aortic Arch Reconstruction Using a Trifurcated Graft
      Ann Thorac Surg, 75:1034-6
    13. Strauch J. et al. (2004)
      Technical Advances in Total Aortic Arch Replacement
      Ann Thorac Surg, 77; 581-90
    14. J Coselli. Personal Communication 23rd September 2003
    15. J Ballard et al. (2002)
      Type III and IV Thoracoabdominal Aortic Aneurysm Repair: Results of a Trifurcated/Two Graft Technique
      J Vasc Surg, 36:211-6
    16. De Paulis R et al. (2001)
      Opening and Closing Characteristics of the Aortic Valve After Valve-Sparing Procedures Using a New Aortic Root Conduit
      Ann Thorac Surg, 72: 487-494
    17. De Paulis R. et al. (2009)
      Recreation of a Sinus Like Graft in Bentall Procedure Reduces Stress at the Coronary Button Anastomoses: A Finite Element Study
      J Thorac Cardiovasc Surg,137:1082-1087
    18. De Paulis, R et al. (2002)
      Analysis of Valve Leaflet Motion After the Reimplantation Type of Valve-Sparing Procedure (David I) With a New Aortic Root Conduit
      Ann Thorac Surg, 74: 53-57
    19. De Paulis, R et al. (2000)

A New Aortic Dacron Conduit for Surgical Treatment of Aortic Root Pathology
Ital Heart J, 1 (7): 457-463

Literature

Literature

Click on the appropriate flag to download a printable version of the Gelweave™ Aortic Root Design literature in PDF format.

English

Gelweave™ Aortic Root Design literature in PDF format will be available soon.

Instructions For Use

IFU - Instructions For Use

Click on the appropriate flag to download the Instructions for Use PDF file in the language of your choice.

Alternatively, right-click on the flag and select the 'Save Target As..' option to save the file for off-line viewing.

Chinese Czech IFU Danish IFU Dutch IFU English IFU French IFU
Chinese Czech Danish Dutch English French
German IFU Greek IFU Hungarian IFU Italian IFU Japan Lithuanian IFU
German Greek Hungarian Italian Japan Lithuanian
Norwegian IFU Polish IFU Portugese IFU Slovakian IFU Spanish IFU Swedish IFU
Norwegian Polish Portugese Slovakian Spanish Swedish
Russian IFU Turkish IFU
Russian Turkey

Gelsoft™ Plus products available subject to local regulatory approval.

 

FAQs

FAQs

1. Can Gelweave™ be used without a cautery?

All woven grafts are prone to fraying when cut with scissors and this may lead to reduced suture retention. Cauteries are used as an alternative minimising the degree of fraying and allowing the graft to be shaped for specific patient needs.

Note: Immersion of the Gelweave prosthesis in saline immediately prior to use will prevent focal burning, which may result during cauterisation. Grafts should be immersed in saline for no longer than 5 minutes. This is not required if already rinsed in Rifampicin and/or Heparin.