Technology in Anesthesiology

The FDA has granted a de novo clearance to Pi-Cardia’s ShortCut device, designed to open up previously implanted heart valves and clear a path for blood to flow into the coronary arteries, allowing patients to undergo a successive transcatheter aortic valve replacement procedure.

As some structural heart implants are only rated to last for a few years, many patients with severely narrowed valves may one day require a replacement procedure – with a new valve placed within the confines of their prior valve. That need may also increase in the future, whether due to older patients living longer or with implants being placed in a comparatively younger population.

However, a problem may arise when the new implant expands and pushes aside the old leaflets, forcing them up against the walls of the heart’s outflow tract and covering up the entrances to the coronary arteries.

Pi-Cardia’s transcatheter ShortCut device is designed to snake into the heart’s preexisting aortic valve, grasp the defunct implant’s leaflets, and quickly slice them in two, removing the potential for obstruction before the placement of the new valve.

The company estimates that more than 42,000 valve-in-valve procedures will be performed annually in the U.S. by 2035, accounting for about 15% of all TAVR surgeries. Pi-Cardia said it also plans to seek future indications for ShortCut, allowing its use in native aortic and mitral valves.

Source: asamonitor.pub/4eQL0yk