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transShield Embolic Protection System

Full Body Protection

Protects all of the cerebral and peripheral vasculatures.

Intuitive Design

Intuitively designed for simple seamless integration into the TAVR procedure.

Transfemoral Access

Inserted through the same transfemoral access site as the pigtail catheter, eliminating the need for an additional access site.

Clinical Evidence

A recent clinical study1 with 3,000 patients, randomized 1:1, with and without the use of an embolic protection device during TAVR demonstrated:

  • Stroke occurs in 2.9% of patients when embolic protection is not used through 72-hours or time of hospital discharge.
  • 21% relative risk reduction in all stroke through 72-hours or time of hospital discharge when embolic protection is used.
  • 60% relative risk reduction in disabling stroke through 72-hours or time of hospital discharge when embolic protection is used.

1) Kapadia, S. R., Makkar, R., Leon, M., Abdel-Wahab, M., Waggoner, T., Massberg, S., … PROTECTED TAVR Investigators. (2022). Cerebral embolic protection during transcatheter aortic-valve replacement. The New England Journal of Medicine, 387(14), 1253–1263. doi:10.1056/NEJMoa2204961

The Embolic Protection System used in Clinical Study1 only provides partial protection to the brain and does not protect the kidneys and downstream vessels.

The transShield Embolic Protection System:

  • Protects all of the vessels leading to the brain, providing full cerebral protection
  • Captures embolic debris flowing to the kidneys and downstream vessels