Current adult-sized artificial heart valves (whether mechanical or bioprosthetic) are fixed in size, unable to expand as a child grows, and therefore unsuitable for babies.
The Expand Valve™ aims to change that. The patent-pending device is an off-the-shelf surgical valve designed specifically for infants.
The device features three highly elastic valve tissue leaflets sutured onto a novel expandable stent. The valve can be balloon-expanded as needed through a minimally invasive procedure, allowing it to increase in size as the child grows.
That stent — a very thin, laser-cut, medical-grade metal frame — is radiopaque, allowing easy visualization and size verification as the child grows. It also includes innovative design elements for streamlined manufacturing, optimal valve performance and precise implantation.
The valve leaflets are made from biocompatible, decellularized biological tissue that can stretch up to 100% without compromising hemodynamics. They are also chemically stabilized and treated with anti-calcification agents to ensure long-term durability.
Unlike other pediatric valves made from non-stretching tissue, the opening of the Expand Valve™ depends on both the stent design and the elasticity of its tissue leaflets.
