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Notice: ValveXchange, Inc. products have not been approved by the U.S. FDA or any other Regulatory Agencies. This website contains forward looking statements which represent management's best judgment, but are speculative and may not occur as projected or not at all.
The Vitality™ Heart Valve System
The VXi Exchangeable Valve System brings together the safety and longevity of time-proven surgical valves, with the least invasive access of the new wave of transcatheter valves. The VXi Vitality™ is based on the off-patent design principles of the industry leading Edwards Perimount™ valve which has demonstrated 18-year durability in some patients.
The Vitality™, however, is a two-part valve. The healed-in support frame of the valve remains in the heart, while the worn-out leaflet set can be quickly exchanged without open-heart surgery or cardiopulmonary bypass. The new leaflet set then provides the same years of service life as the original with no reduction in valve function.
The VALVEXCHANGE™ procedure can be done without open chest surgery or cardiopulmonary bypass. It can be done transapically, through a small incision between the ribs and a small hole in the apex of the heart, both of which heal readily. Minimally Invasive Surgery (MIS) is now performed routinely at many surgical centers. With the VALVEXCHANGE™ technology, off-pump MIS techniques can be applied to both the initial implant and subsequent exchanges later in life.
Unlike transcatheter valves, the advanced VALVEXCHANGE™ approach is without compromise. It offers minimally invasive, off-pump approach for the implant of a highly durable, long-lasting tissue valve, and exchangeable leaflets. Please see the Patient Dilemma Section for the compromises between Mechanical Valves, Tissue Valves and Transcatheter valves. TOP
The Exchangeable Tissue Valve
The design of the VXi Vitality™ exchangeable tissue valve grows out of the proven design features of the bovine pericardial heart valve – the Edwards Perimount™ valve. This valve is now off-patent, and the design features that give it its 18-year durability can now be implemented in the next generation of tissue valves. Visually, the Edwards Perimount™ and the VXi Vitality™ are nearly identical.
The main difference between the two valves is beneath the skin. In the Perimount™ valve, the frame that holds the leaflets is permanently connected to the base of the valve – to the sewing cuff. In the Vitality™, the frame is snapped onto the base and held securely by clips hidden within the stent posts. The system is designed to be released only by a specialized tool. Schematically, the components of the system are shown below.
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 later when replacement is required. The exchangeable components collapse into a size small enough to be inserted and removed through an incision in the heart, without requiring the patient to be placed on cardiopulmonary bypass. TOP
Valve Delivery and Exchange System:
The VALVEXCHANGE procedure is designed to be performed using a range of approaches, from open surgical to minimally invasive, to off-pump transapical, depending on the clinical indication of the patient and physician recommendation. The exchange tools are scalable between surgical and transapical approaches, and robust enough to extract the leaflet set regardless of the degree of fibrotic overgrowth. Schematically, the exchange tools are shown below.
The VALVEXCHANGE system has three tools that work in concert with each other. These are (i) valve stabilizer, (ii) valve removal tool, and (iii) valve insertion tool. All three tools nest within each other coaxially so that once one tool is aligned to the stent posts, all others become aligned also. The valve stabilizer grabs onto the docking station and the extraction tool grabs onto the exchangeable leaflet set. Relative force is then applied between the two tools to pull the leaflet set off the docking station. This relative force is applied by way of a handle, much like bicycle brake calipers squeeze the wheel without actually pushing left or right. In the a similar way, the exchange tool set applies a relative force between the two valve components, shielding the heart from any direct pulling or pushing. An animation of this, as applied to a transapical exchange system, can be viewed here.