FDA Radiology AI Devices

The ShortCut device by Pi-Cardia Ltd. is a single-use catheter designed to safely split bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures in patients at risk of coronary obstruction. This catheter-based tool is inserted via the femoral artery and positions its distal cutting element on valve leaflets to perform precise cuts, helping improve blood flow and reduce complications during transcatheter valve replacement procedures. It has been demonstrated in clinical studies to be effective and safe, providing a new treatment option for high-risk patients undergoing valve-in-valve procedures.