First Dedicated Device Enables Coronary Access and Prevents Coronary Obstruction During Transcatheter Aortic Valve Replacement

The first in-human procedure has been successfully conducted with the world’s first dedicated device designed to split the leaflets of a pre-existing valve to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk for coronary obstruction or compromised coronary access.

Pi-Cardia Ltd.’s (Rehovot, Israel) ShortCut device is the first dedicated device to enable coronary access and prevent coronary obstruction during TAVR. The TAVR market, currently estimated at USD 5 billion, is predicted to double over the next five years, with the expansion into low-risk younger patients. However, this growth may be hindered by a fundamental challenge: During TAVR implantation, the leaflets of the pre-existing valve are pushed sideways, in a way which may compromise future coronary access in many patients. This can turn into a life-threatening complication of complete coronary obstruction in a significant number of patients who undergo a second valve implantation when their previous bio-prosthetic valve degenerates. ShortCut may be used in both situations to split the pre-existing valve leaflets to enable future coronary intervention and prevent coronary obstruction. ShortCut is the latest addition to Pi-Cardia’s product offering, which includes the Leaflex device - a standalone, non-implant-based treatment for patients with aortic stenosis. Leaflex performs mechanical scoring of valve calcification, in order to restore leaflet mobility and improve hemodynamics. Clinical trials are underway in the US, Europe, and China.

“Using ShortCut we were able to treat two extremely complex patients with degenerated valves that needed a solution to prevent coronary obstruction after TAVR. In both patients we were able to effectively split the leaflets within minutes, allowing for a safe implantation of both self-expanding and balloon expandable TAVR valves,” said Dr. Danny Dvir who performed the first ShortCut procedures at Shaare Zedek Medical Center. “ShortCut addresses an unmet need for a simple tool to prevent coronary obstruction, which I strongly believe can easily be adopted by all TAVR centers. I can also see ShortCut being used to prepare bicuspid valves in selected cases, by splitting the fused leaflets or tri-cuspidizing the bicuspid valves, enabling an optimal TAVR result in this patient population.”

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