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ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction.

The ShortCut is a transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to transfemoral aortic valve replacement (TAVR), to reduce the risk of coronary ostium obstruction and coronary access compromise and enable a valve-in-valve procedure for patients at risk of coronary obstruction. Splitting of a leaflet creates a triangular opening in the leaflet that allows blood flow into the adjacent coronary artery.

The ShortCut is a sterile, single use, 16 Fr device which is inserted through the femoral artery over a guidewire into the left ventricle using standard catheter placement techniques. The ShortCut is comprised of the following parts:

• a. Distal Unit (DU) Distal end of the catheter which contacts the valve leaflets and splits them (Figure 1). It is comprised of the Splitting Element (SE) and the Positioning Arm (PA). The Splitting Element penetrates the leaflet from the ventricular side at the bottom of the leaflet and performs the cut. The Positioning Arm is positioned on the aortic aspect of the leaflet and acts as a protective stabilizer for the activated SE. The DU is delivered in a sheathed 16 Fr configuration that is opened upon reaching the target site.
• b. Delivery System (DS) The catheter shafts connect the Handle to the DU and delivers the required movements from the Handle to the DU. The DS is compatible with a 16 Fr introducer sheath and is delivered over a 0.035" Guide Wire (GW). The outer shaft of the DS (Sheathing Tube) is used to sheathe the DU during introduction and removal from the body. The inner shafts of the DS. together with its pig-tailed tip, enable flexing and positioning of the DU at the valve.
• c. Handle The user interface, designed to control the DS and the DU and to enable correct positioning of the DU on the valve (Figure 2).

The provided document describes the acceptance criteria and the study that proves the ShortCut device meets these criteria. The device is a percutaneous catheter system intended to split bioprosthetic aortic valve leaflets prior to transcatheter aortic valve replacement (TAVR) to reduce the risk of coronary obstruction in valve-in-valve (ViV) procedures.

Here's an organized summary of the requested information:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly derived from the success rates of the primary effectiveness and safety endpoints, as well as the composite technical success endpoint.

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