Car designers have long known that besides optimizing initial quality it is important to make fixing the car an easy task. Auto mechanics themselves prefer to own and recommend cars easy to work on, while the repair costs for consumers are lower compared to similar, harder to fix vehicles. As technology is becoming exceedingly capable of replacing our own worn out parts, designing them with consideration for future repair can lead to substantial clinical benefit.
Case in point is ValveXchange (Greenwood Village, CO), a company that developed the Vitality bioprosthetic heart valve based on the successful off-patent Edwards Perimount. The main difference, though, is that the valve’s bovine-sourced leaflets, which have a limited lifetime, are replaceable through a minimally invasive transcatheter procedure. The company just finished a multi-center clinical trial of the valve in Germany, Austria and Poland, and has filed for European clearance of the device based on the trial’s findings.
From the product page:
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.
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.
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.