The development of transcatheter heart valves: opportunities and challenges

Although the heart valve market is relatively mature, many patients currently indicated for valve repair or replacement are either undiagnosed, not referred for surgery, or are too sick/unwilling to undergo the required surgery (Table I). To address this unmet clinical need, 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.