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Surgical Products
The only all-biological valved conduit for use in the aortic position
Combines a Porcine Valve with Bovine Conduit - no synthetic material
- Resists stenosis, calcification, dilatation, and thrombosis - see the 10 year follow up paper
- Excellent haemodynamics and easy to implant
- Resists tissue “remodelling” that can lead to dilatation in the Ross procedure
- 17 years clinical experience
- No long-term anticoagulation needed in any population
- Demonstrated to resist infection as well as a homograft
- Can be oversized to maximize flow
- No dilatation due to effective No-React treatment
- Zero porosity: one layer of bovine pericardium
- Promotion of functional endothelial lining
- Available in a variety of sizes (21 - 29mm) to prevent mismatch
No-React® Valved Aortic BioConduit
DISCUSSION
Valved conduits are typically available in three different designs:
1. Mechanical valves in woven polyester fabric conduits (collagen coated and noncoated).
2. Homografts.
3. Xenografts in woven polyester fabric conduits
The BioIntegral No-React BioConduit Aortic Valved Conduit gives surgeons a better alternative. It contains a composite stentless valve, with superior haemodynamics, compared to mechanical valves. Since it is made of only biological materials, the risk of infection can be reduced. The conduit contains a composite porcine valve with excellent haemodynamic properties. The conduit is made of a No-React treated bovine pericardial tube. The risk of infection is reduced because only natural material is used. There is also no need for long-term anticoagulation therapy
The unique handling, haemostasis, infection resistance and availability are clinically-proven unique advantages over synthetic conduits and homografts. The only realistic comparison product is indeed the homograft, but the off-the-shelf availability of the BioConduit means that it removes the dependency on having an appropriate sized homograft available.
The main basis of the CE approval is the strong safety and efficacy performance despite very difficult clinical contexts. Given a surgeon's preference to preserve the native aortic root when possible, the Bentall procedure is typically reserved for more difficult cases of degeneration. Despite the degenerated tissues, common presence of infection and concomitant procedures, the BioConduit's performance even comfortably exceeds the ISO 5840 standards of safety and efficacy for aortic valves in the more general and safer replacement setting.
