The development of transcatheter heart valves: Opportunities and challenges

The medical device industry has undertaken the development of transcatheter heart valves (TCV). These devices are tissue heart valves that can be delivered without open heart surgery and are intended to complement the portfolio of current and future surgical valve products. Several companies have developed novel product designs. Some transcatheter valves are currently available for the aortic and pulmonic positions via European CE mark, and are in clinical trials throughout the United States. Although substantial progress has been made, the biomedical engineering community can provide tremendous value to both patients and clinicians through continued innovation in product design, development of new tools for product testing, and through novel means of improving the ease and accuracy of device deployment. In addition, smaller crimp profiles may be feasible as technology and design advancements are made. A smaller TCV could then target a larger patient population, and allow easier delivery during procedures for patients with tortuous and severely diseased anatomies.