Stroke Risk is Unpredictable
In the SENTINEL IDE, prospective assessment by neurologists revealed that almost
TAVR patients showed overt signs of ischemic brain injury, post-procedure.
Clinical evidence shows that cerebral embolic debris is generated in the vast majority of patients undergoing TAVR, regardless of patient risk profile or valve type.7, 9, 10
The SENTINEL IDE showed that 1 in 4 TAVR patients had an average of 25 pieces of debris captured and removed by the SENTINEL Cerebral Protection System (CPS) that were visible to the naked eye.5
Debris captured by SENTINEL CPS
Debris Captured in 99% of Procedures7
SENTINEL IDE Trial
SENTINEL IDE Trial
independent of STS score 5, 11, 12
The data in the chart did not reach statistical significance, per Fisher’s Exact Test.
Economics and the Use of SENTINEL
CPS to Grow your TAVR Program
Supporting the Use of SENTINEL in TAVR
SENTINEL IDE Trial: All-Stroke Post-TAVR7
- Primary Safety endpoint met with a
30-Day MACCE rate of 7.3%
- Statistically significant 63% peri-procedural (≤72 hours) stroke reduction with SENTINEL CPS
- Cerebral debris captured and removed in 99% of patients protected with the SENTINEL device
95% of SENTINEL patients were evaluated by neurologists
Clinical Events Committee included stroke neurologists
SENTINEL CPS Achieves Favorable Safety Outcomes in IDE Trial7
* MACCE defined as Death (any cause), Stroke (any),
Acute Kidney Injury (Stage 3).
SENTINEL CPS Demonstrates Consistent Reductions in New Lesion Volumes
Sentinel CPS Demonstrates Consistent Reductions in Stroke Across Multiple Randomized Control Trials and Global Real World Studies5, 16-18
with an average absolute reduction of 3-4% at 72 hours & 7 days post TAVR
SENTINEL CPS is by far the most widely studied cerebral protection device with safety demonstrated for over 3,500 patients across three randomized trials and independent real world studies.16-18
16. Van Mieghem N, Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, Erasmus Medical Center, presented at TVT 2018. | 17. Seeger J., Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, University of Ulm, presented at TVT 2018. | 18. Chakravarty T, Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, Cedars Sinai Medical Center, presented at TVT 2018.