The Heart Valve System

The VXi System consists of a two-piece valve and the associated tools for replacing the exchangeable component. The permanent component is a surgically-implantable support frame or "docking station" that provides a structurally sound foundation for the exchangeable leaflet set.

As in all bioprosthetic valves, it is the leaflet tissue that eventually wears out and tears, necessitating the surgical replacement of the entire valve. In bovine pericardial valves, the most commercially successful valves, pericardial tissue leaflets are mounted on a thin, flexible wireform which is affixed permanently to the support frame during valve manufacture. The support frame is engineered to provide optimal geometry and compliance for the leaflets, minimizing the accumulation of fatigue damage as these leaflets snap open and shut 35 million times per year.

In the VXi valve, the geometry and compliance of the supporting frame is similarly optimized to minimize fatigue, but the flexible wireform is NOT permanently attached to the supporting frame. Instead, it is held in place by three clips, designed to be released by a specialized exchange tool in a fail-safe fashion. When these leaflets wear out, the exchange tool is preloaded with a new valve and inserted into the patient in a rapid, minimally invasive manner that does not require cardiopulmonary bypass.

The Two-part Valve

The design of the VXi exchangeable valve grows out of the proven design features of the latest generation bovine pericardial heart valves. It is a two-component device consisting of a permanent “docking station”, and a collapsible inner frame. The collapsible frame contains leaflets, made from chemically preserved bovine pericardium, that can be delivered in a collapsed state, expanded and seated in the permanent docking station, then re-collapsed several years later when replacement is required. The exchangeable components collapse into a size small enough to be inserted and removed percutaneously or through an incision in the aorta. Different leaflet designs and materials can be incorporated into the exchangeable component, allowing the patient to benefit from the latest biomaterials.

Valve Delivery System

The VALVEXCHANGE procedure is performed using a range of approaches, ranging from open surgical to minimally invasive, to transcatheter, depending on the clinical indication of the patient and physician experience. The exchange tools are scalable between surgical and percutaneous approaches, and robust enough to extract the wireform regardless of the degree of fibrotic overgrowth.