Stroke Happens PROTECTION Works

Medical Specialties > Structural Heart > SENTINEL™ Cerebral Protection System

SENTINEL™ Cerebral Protection System (CPS)

The SENTINEL Cerebral Protection System protects the brain from harmful debris released during endovascular procedures.
Protected TAVI™ with SENTINEL CPS gives you the power to reduce stroke during a TAVI procedure.

Instructions for Use

Stroke Risk is Unpredictable

Stroke Data & Occurence

Stroke and neurological impairment
can be a serious and potentially
devastating event.

The effects are often underreported and underdiagnosed.^1-5
Stroke risk is unpredictable, independent of experience, operator volume or risk score.

4%

Weighted-average all-stroke rates
across contemporary studies -
independent of center experience,
operator volume or patient risk score.

>9%

Stroke rate showing
in studies that include a mandated
neurological assessment.

^{1. Manoharan, et al., J Am Coll Cardiol Intv 2015; 8:1359-67. | 2. Wendler O et al. Circulation 2017;135:1123–1132. | 3. Seeger J et al. Eur Heart J. 2018 Dec 24. doi: 10.1093/eurheartj/ehy847. | 4. Haussig S et al., JAMA 2016;316:592–601. | 5. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377.}

In the SENTINEL IDE, prospective assessment by neurologists revealed that almost

1 in 10

TAVI patients showed overt signs of ischemic brain injury, post-procedure.

Most cerebrovascular events take place acutely within 24 hours of the index procedure.

SENTINEL Cerebral Protection System (CPS)

Debris Matters

The SENTINEL IDE showed
a high rate of debris capture.⁷

Clinical evidence shows that cerebral embolic debris is generated in the vast majority of patients undergoing TAVI, regardless of patient risk profile or valve type.^{7, 9, 10}

The SENTINEL IDE showed that 1 in 4 TAVI patients had an average of 25 pieces of debris larger than 0,5mm of size captured and removed by the SENTINEL Cerebral Protection System (CPS) that were visible to the naked eye.⁵

^{Debris captured by SENTINEL CPS}

^{5. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377. | 7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017. | 9. Van Mieghem NM, Schipper ME, Ladich E, et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 2013;127:2194–201. | 10. Schäfer U. Safety and Efficacy of Protected Cardiac Intervention: Clinical Evidence for Sentinel Cerebral Embolic Protection. Interv Cardio Review. 2017;12(2):128–32.}

Debris Captured in 99% of Procedures⁷
SENTINEL IDE Trial

Watch the video to hear physician

perspectives on embolic debris during TAVI.

	*Whenever you implant a valve debris will dislodge and travel to the brain."*

Debris Capture Video Nicolas van Mieghem

The capture of embolic debris is universal regardless of valve types or patient risk profile, supporting the potential benefit of using cerebral embolic protection in all TAVI procedures. ^{5, 7, 11, 12}

View Images

^{Debris Capture

independent of STS score ^{5, 11, 12}}

_{The data in the chart did not reach statistical significance, per Fisher’s Exact Test.}

^{5. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377. | 7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017. | 11. Schmidt et al. JACC Cardiovasc Interv. 2018. 9(13):1262-1273. | 12. Jensen et al., Prevalence and etiopathology of thromboembolic debris during transcatheter interventional aortic valve replacement: results of the SENTINEL H-study, EuroPCR 2016.}

Stroke Burden

Economic Data

Stroke and stroke-related incidents can account for increased hospital
costs, increased length of stay, and higher readmission rates.¹³

Hospitalization
costs are

33%

HIGHER

for TAVI procedures
with stroke

Hospital length
of stay is

6 DAYS

LONGER

(on average) for TAVI
procedures with stroke

30-Day
readmissions are

31%

HIGHER

for TAVI procedures
with stroke

^{13. Alqahtani F et al. SH Journal, 3(1):72–73.}

Learn more about Stroke
Economics and the Use of SENTINEL
CPS to Grow your TAVI Program

	*But it is not only mortality. It is also clearly morbidity and its costs, hospital stay and logistics of the procedure."*

Patient Testimonial

The physical and emotional impact
of stroke affects both patients
and their caregivers.

Cerebral protection may reduce long-term cognitive impairment.

Stroke or neurological impairment fears from patients include: losing the ability to live independently, creating a burden on their families and the need for higher levels of skilled care.

Hear a TAVI patient’s perspective
on cerebral protection with TAVI

	*I wanted to have my brain protected."*

Clinical Data

Growing Clinical Evidence

A growing body of clinical evidence
provides a strong foundation for the
benefits of Cerebral Embolic
Protection and the SENTINEL Cerebral
Protection System.

Hear a Contemporary Review of the Data
Supporting the Use of SENTINEL in TAVI

	*Sentinel is Safe, Effective and we see a 60-70% reduction in All-Stroke with this device."*

_{Courtesy of Prof. Jochen Wöhrle, University of Ulm}

Randomized Controlled Trials

SENTINEL IDE Randomized Control Trial⁷ is the first randomized clinical trial approved by the FDA evaluating cerebral protection in TAVI.

SENTINEL IDE Trial: All-Stroke Post-TAVI⁷

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

Cerebral Emboli detected on DW-MRI increases the risk of overt Stroke by 2-4 times¹⁵

^{4. Haussig S et al., JAMA 2016;316:592–601. | 7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017. | 14. Van Mieghem N, et al. EuroIntervention 2016;12:499-507. | 15. Vermeer SE, et al., Lancet Neurol. 2007; 6 : 611.}

Sentinel CPS Demonstrates Consistent Reductions in Stroke Across Multiple Randomized Control Trials and Global Real World Studies^{5, 16-18}

A 60-80% peri-procedural relative reduction in neurologist-adjudicated TAVI All-Stroke
with an average absolute reduction of 3-4% at 72 hours & 7 days post TAVI

^{5. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377. | 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.}

Post Approval Studies

Largest Propensity Matched Meta-Analysis Comparison shows stroke and all cause mortality reduction with SENTINEL CPS¹⁷

All-procedural Stroke

All-cause Mortality or Stroke

Disabling Stroke

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.}

Procedural Efficiency

SENTINEL is Safe, Fast, and Effective

SENTINEL CPS Does Not Impact Cath Lab Workflow or Procedural Timing⁷

99.4%

PROCEDURAL SUCCESS with at least 1 filter deployed (94.4% with both filters)

4 MINS

median deployment time
to place both filters

90%

of anatomies covered
with one size

0.4%

access site-related vascular
complication rate.

MINIMAL INTERFERENCE with advancement of the TAVI device

^{7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017.}

Top

Stroke Happens PROTECTION Works

SENTINEL™ Cerebral Protection System (CPS)

Stroke Risk is Unpredictable

Stroke Data & Occurence

Stroke Data & Occurence

Stroke and neurological impairment can be a serious and potentially devastating event.

4%

>9%

In the SENTINEL IDE, prospective assessment by neurologists revealed that almost

1 in 10

TAVI patients showed overt signs of ischemic brain injury, post-procedure.

Debris Matters

Debris Matters

The SENTINEL IDE showed a high rate of debris capture.7

Debris captured by SENTINEL CPS

Debris Captured in 99% of Procedures7SENTINEL IDE Trial

Debris Capture independent of STS score 5, 11, 12

Stroke Burden

Economic Data

Economic Data

Stroke and stroke-related incidents can account for increased hospital costs, increased length of stay, and higher readmission rates.13

33%

HIGHER

6 DAYS

LONGER

31%

HIGHER

Patient Testimonial

Patient Testimonial

The physical and emotional impact of stroke affects both patients and their caregivers.

Clinical Data

Growing Clinical Evidence

Growing Clinical Evidence

A growing body of clinical evidenceprovides a strong foundation for the benefits of Cerebral Embolic Protection and the SENTINEL Cerebral Protection System.

Courtesy of Prof. Jochen Wöhrle, University of Ulm

Randomized Controlled Trials

Randomized Controlled Trials

SENTINEL IDE Randomized Control Trial7 is the first randomized clinical trial approved by the FDA evaluating cerebral protection in TAVI.

SENTINEL IDE Trial: All-Stroke Post-TAVI7

SENTINEL CPS Achieves Favorable Safety Outcomes in IDE Trial7

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

Post Approval Studies

Post Approval Studies

Largest Propensity Matched Meta-Analysis Comparison shows stroke and all cause mortality reduction with SENTINEL CPS17

All-procedural Stroke

All-cause Mortality or Stroke

Disabling Stroke

Procedural Efficiency

SENTINEL is Safe, Fast, and Effective

SENTINEL is Safe, Fast, and Effective

SENTINEL CPS Does Not Impact Cath Lab Workflow or Procedural Timing7

99.4%

4 MINS

90%

0.4%

Stroke and neurological impairment
can be a serious and potentially
devastating event.

The SENTINEL IDE showed
a high rate of debris capture.⁷

^{Debris captured by SENTINEL CPS}

Debris Captured in 99% of Procedures⁷
SENTINEL IDE Trial

^{Debris Capture

independent of STS score ^{5, 11, 12}}

Stroke and stroke-related incidents can account for increased hospital
costs, increased length of stay, and higher readmission rates.¹³

The physical and emotional impact
of stroke affects both patients
and their caregivers.

A growing body of clinical evidence
provides a strong foundation for the
benefits of Cerebral Embolic
Protection and the SENTINEL Cerebral
Protection System.

_{Courtesy of Prof. Jochen Wöhrle, University of Ulm}

SENTINEL IDE Randomized Control Trial⁷ is the first randomized clinical trial approved by the FDA evaluating cerebral protection in TAVI.

SENTINEL IDE Trial: All-Stroke Post-TAVI⁷

SENTINEL CPS Achieves Favorable Safety Outcomes in IDE Trial⁷

Sentinel CPS Demonstrates Consistent Reductions in Stroke Across Multiple Randomized Control Trials and Global Real World Studies^{5, 16-18}

Largest Propensity Matched Meta-Analysis Comparison shows stroke and all cause mortality reduction with SENTINEL CPS¹⁷

SENTINEL CPS Does Not Impact Cath Lab Workflow or Procedural Timing⁷