This is a prospective, multi-center, single arm feasibility study to assess the safety and performance of the transShield EPS. Patients with severe native aortic valve stenosis scheduled for TAVR will be screened for study eligibility. Subjects who meet the commercially approved indications for TAVR and comply with the study inclusion/exclusion criteria are eligible for enrollment. Patients will be followed for 30 days post procedure.
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).