Product Information
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Key Benefits
- Innovative self-sealing trilaminate graft material
- Pre-sewn device reduces procedure complexity and prevents valve-to-graft mismatch
- Closely matches aortic root anatomy
- Reduces patient risk – potential for reduced bypass, cross-clamp and procedural time1,2
- Enables treatment of vulnerable patient groups
BioValsalva™ Porcine Aortic Valved ConduitSummary
The world's first pre-sewn composite biological porcine aortic valved conduit.
BioValsalva™, the Biological Bentall, is a unique porcine aortic biological valved conduit and utilises the geometry of the Gelweave Valsalva™ graft.
It is a pre-sewn device combining an innovative trilaminate graft material with the elan™ porcine stentless biological valve.
Product Details
BioValsalva™, the Biological Bentall, is the world's first pre-sewn composite biological porcine aortic valved conduit and is indicated for aortic heart valve replacement, and the associated repair or replacement of damaged and diseased ascending aorta in cases of aneurysm, dissection or dilatation.
It is a pre-sewn device combining an innovative trilaminate graft with the elan™ porcine stentless biological valve.
The graft material comprises of three layers; inner woven polyester, central elastomeric membrane and outer ePTFE wrap. This combination provides superb handling, excellent suturability rapid haemostasis and prevents the need for re-operations.3,4
Like Gelweave Valsalva™, BioValsalva™ has 3 discrete sinuses at the proximal end of the product. These mimic the shape of the natural sinuses and have the potential to:
- Minimise the impact of the leaflets on the conduit during valve opening and on each other during closure4
- Improve blood flow to the coronary arteries 4
- Reduce tension on the coronary anastomoses5
The elanTMporcine stentless aortic valve demonstrates “…very low transvalvular gradients, good flow characteristics and low regurgitation incidence” 6
BioValsalva™ “…eliminates the ischaemic time needed for construction of a valved conduit during the procedure and the risk of valve malfunction” 4
Please click here to view a live implantation.
This is also available in DVD format, please This email address is being protected from spambots. You need JavaScript enabled to view it. to request a copy.
Please click on the appropriate flag to view or download a printable PDF file of the BioValsalva™ Implantation Technique booklet in the language of your choice. Please ensure that the product Instructions For Use (IFU) is followed.
English French German Italian Spanish Product available subject to local regulatory approval
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Literature
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Literature - Proven Biological Valves
Click on the appropriate flag to download a printable version of the Proven Biological Valves literature in PDF format.
English French German Italian Spanish Animation
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BioValsalva™ Implant Animation
This animation is also available in DVD format, please click This email address is being protected from spambots. You need JavaScript enabled to view it. to request a copy.
FAQs
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FAQs
1. What are the components of the product?
- elan™ porcine stentless valve
- Triplex™ graft material with Valsalva™ technology
- Porcine pericardium
- Fabric sewing cuff
2. What is the Triplex™ material?
- Inner Twillweave™ woven polyester fabric that is the base material used in our Gelweave™ range
- Middle layer of elastomeric membrane
- Outer PTFE wrap
Triplex™ is made from three separate layers and contains no animal derived sealants.
3. Can I cauterise the Triplex™ graft material?
No. Holes for the coronary buttons should be fashioned with a sharp instrument.
4. What type of heart valve is used in the product?
It is the Vascutek elan™ porcine stentless valve – a one-piece natural valve.
5. What is the product stored in?
0.5% glutaraldehyde solution.
6. How do I choose what size of product to use?
This should be decided based on the intra-annular diameter using a Vascutek stentless elan™ sizing set (Cat No: 014. Sizes 19, 21, 23, 25, 27 and 29mm diameter). The handle also is available on its own (Cat No: 017).
7. The product is slightly discoloured. Is this a problem?
No – storage in 0.5% glutaraldehyde solution can cause this but the performance of the product is not affected.
8. How do I prepare the product for implantation?
See labelling and IFU for details.
9. Will you perform any in-service training?
Yes, when a hospital starts using BioValsalva™ we will send a company sales specialist to attend the first procedure.
10. Where are the products made?
The CE marked Triplex™ grafts are made at Vascutek Scotland. The CE marked stentless elan™ valves are processed at Vascutek in Leeds, England. Vascutek Scotland is the legal manufacturer of BioValsalva™.
11. Can I use my own set of sizers?
No, for accurate sizing use only the Vascutek stentless elan™ sizing set, Cat No: 014.
12. Are the sizer sets provided sterile?
No, the sizer sets are provided non-sterile and have to be sterilised prior to use as detailed in the IFU. The recommended method of sterilisation is autoclaving.
13. How many times can the sizers be re-sterilised?
Up to 100 times in accordance with the IFU.
14. Which sutures should I use?
The sutures that you currently use for root procedures will be suitable.
Related Products
elan™
The elan™ valve is freshly harvested and carefully assessed before being prepared and configured non-stented for fixation. This valve has no cloth covering and apart from suture material the valve is constructed entirely from porcine root and pericardium.
Gelweave™ Aortic Root Designs
Gelweave Valsalva™, the world’s first aortic root graft. It is used in valve sparing or combined prosthetic valve implant procedures.