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 number of 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.
“With FDA clearance now in hand, we are focused on building a strong commercial and clinical support team to execute a limited commercial launch while ensuring optimal patient outcomes,” CEO Erez Golan said in a statement. The device previously received a breakthrough designation from the agency in January.
Pi-Cardia is also developing Leaflex, a non-implant treatment for aortic stenosis, which aims to crimp the calcium buildup around the leaflets in such a way that allows the valve to continue to close along its natural folds and form a tighter seal.