Product Information

Key Benefits

• Innovative self-sealing Triplex^TM 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 time^1,2
• Enables treatment of vulnerable patient groups

Summary

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 Triplex™, 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 Triplex™, an innovative trilaminate graft with the elan™ porcine stentless biological valve.

Triplex™ comprises 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 elan^TM porcine 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.

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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

Literature

Click on the appropriate flag to download a printable version of the BioValsalva™ literature in PDF format.

English	French	German	Italian	Spanish

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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

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Literature - Porcine Heart Valve Products

Click on the appropriate flag to download a printable version of the Proven Heart Valve Products literature in PDF format.

English

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	Danish	Dutch	English	French
German	Greek	Hungarian	Italian	Lithuanian	Norwegian
Polish	Portugese	Slovakian	Spanish	Swedish	Turkish

Animation

BioValsalva™ Implant Animation

This animation is also available in DVD format, please click This e-mail address is being protected from spambots. You need JavaScript enabled to view it to request a copy.

FAQs

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.