Self-Centering Guide Catheter Feasibility Study

A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide
Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR)
of a native valve with a transcatheter aortic valve that is introduced percutaneously via the
femoral artery using conventional catheterization techniques will be evaluated for enrollment
in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a
guidewire across a stenotic native aortic valve and into the left ventricle.

Inclusion Criteria:

- Subject must be at least 18 years of age.

- Subject (or legal guardian) understands the study requirements and the treatment
procedures and provides written informed consent before any study-specific tests or
procedures are performed.

- Subject is eligible for and is an acceptable candidate for transcatheter aortic valve
replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or
mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is
introduced percutaneously via the femoral artery using conventional catheterization
techniques.

Exclusion Criteria:

- Subject has known hypersensitivity to the components of the device (e.g., polyether
block amide, fluoropolymers, nickel, platinum, tantalum, titanium).

- Subject has a pre-existing prosthetic aortic valve.