Pi-Cardia has received FDA clearance for its Shortcut device, designed to reduce the risk of coronary artery obstruction during valve-in-valve transcatheter aortic valve replacement (TAVR) procedures. Valve-in-valve TAVR, which addresses failing TAVR devices without the need for open-heart surgery, can pose a risk of coronary blockages due to displaced aortic valve leaflets. Shortcut mitigates this risk by mechanically splitting the leaflets before valve placement.
The device, which uses a blade rather than electrosurgery, differs from similar technologies like the NIH’s Basilica. Clinical studies of Shortcut have shown the procedure to be teachable and effective, making it easier for broader adoption. Pi-Cardia aims for a limited launch and plans future expansions to cover native and bicuspid valves, potentially requiring leaflet modification in 30% of cases to ensure optimal patient outcomes