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The PROTECTED TAVR Study

New data showed a 21% relative risk reduction in all stroke and a 60% significant relative risk reduction in disabling stroke through 72-hours.¹

Every patient deserves protection from disabling stroke

Safeguard quality of life for Transcatheter Aortic Valve Replacement (TAVR) patients in just four minutes2 per procedure. New data from the PROTECTED TAVR Study showed SENTINEL™ Cerebral Protection System (CPS) reduced the risk of disabling, perioperative stroke by 60% through 72-hours.1


The PROTECTED TAVR Study

Study objectives

To demonstrate that use of the SENTINEL CPS significantly reduces the risk of peri-procedural stroke (≤ 72-hours) after TAVR.

The PROTECTED TAVR Study is the largest randomized TAVR trial to date with 3,000 patients enrolled at >50 global sites who were randomized 1:1 – patients protected with SENTINEL vs. no use of SENTINEL during TAVR. All risk categories were eligible for inclusion, including low risk patients and all commercially available valves included as part of the trial.

Primary Endpoint: All Stroke  (hemorrhagic, ischemic, or undetermined status; disabling or non-disabling) through 72-hours post TAVR procedure or hospital discharge.

Transient ischemic attack (TIA) and delirium were also reported on as part of the secondary neurological endpoints.

All patients enrolled in the trial underwent neurological examination at baseline and post TAVR procedure (discharge or 72-hours, whichever came first). This assessment was performed by a neurology professional (board certified/board eligible neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner).

Study design
*Any commercially available TAVR device; ‡ Neurological examination at baseline, and post-procedure and through 72 hours after TAVR or discharge (whichever comes first), performed by a neurology professional (board certified/board eligible neurologist, neurology fellow, neurology physician assistant, or neurology nurse practictioner)

PROTECTED TAVR results

The primary endpoint did not meet statistical significance, but the data demonstrated a numerical trend towards a lower rate of stroke in patients treated with the SENTINEL device, representing a 21% relative risk reduction in all stroke through 72-hours or time of hospital discharge.

A secondary analysis demonstrated a statistically significant 60% relative risk reduction in disabling stroke through 72-hours or time of hospital discharge in patients treated with the SENTINEL device.

PTAVR_stroke_chart

Strong safety profile

The SENTINEL CPS demonstrated excellent safety with high rates of device delivery/retrieval (94.4%) and very low rates of vascular complications (0.1%).1

94%

Safe and effective device delivery

New data showed a 21% relative risk reduction in all stroke and a 60% significant relative risk reduction in disabling stroke through 72-hours. See the study.
94%

Low access site complications

New data showed a 21% relative risk reduction in all stroke and a 60% significant relative risk reduction in disabling stroke through 72-hours. See the study.

Stroke persists as an indiscriminate risk

It is impossible to predict which TAVR procedures will dislodge embolic debris, and when it will cause disabling stroke. 4 minutes per procedure are enough to achieve safe & effective device delivery.

Every patient is a candidate for protection from disabling stroke

The effect of SENTINEL on disabling stroke was consistent across patients' subgroups.

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Panel Discussion PROTECTED TAVR Trial

This panel of experts discuss the current cerebral embolic protection (CEP) landscape, the PROTECTED TAVR trial results and what is next for CEP.


EXPERT PERSPECTIVES

See how heart teams are using cerebral embolic protection

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SENTINEL Indication for Use

The SENTINEL Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.

The diameters of the arteries at the site of filter placement should be between 9.0 mm – 15.0 mm for the brachiocephalic and 6.5 mm – 10.0 mm in the left common carotid.

References

1. Kapadia, S. PROTECTED TAVR Trial data presented at TCT 2022.

2. Boston Scientific data on file.

All photographs taken by Boston Scientific. Illustrations for informational purposes only – not indicative of actual size or clinical outcome.

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