Sentinel – Cerebral Embolic Protection Device
It is indicated for use as a cerebral protection device to capture and remove embolic material while performing transcatheter aortic valve procedures in order to reduce ischemic injury to the brain peri-procedurally.
Sentinel – Cerebral Embolic Protection Device (Cerebral Protection System), is designed to capture and remove embolic material (thrombus/debris) that may enter
the cerebral vascular system during TAVI which in turn may lead to embolic ischemic strokes.
The Sentinel Cerebral Protection System is the only US FDA approved percutaneously delivered dual-filter cerebral embolic protection device, designed to capture, and remove debris dislodged during Transcatheter Aortic Valve Implantation/Replacement (TAVI/TAVR) procedures to reduce the risk of stroke
Sentinel – Cerebral Embolic Protection Device
Why is cerebral protection is needed?
Stroke is an unpredictable and devastating event that is underdiagnosed in TAVI.
➢ SENTINEL IDE Trial showed a 30-day stroke rate of 9.1% in unprotected TAVI, as revealed by prospective assessment and adjudication by stroke neurologists. Cerebral embolic debris is generated in at least 99% of TAVI patients.
➢ Cerebral protection systems (CPS) are intended to prevent cerebral embolization and have proven efficacy in the related field of carotid and saphenous vein graft stenting with clinically significant reductions in major adverse events (such as mortality, stroke, and myocardial infarction).
➢ Embolic debris includes pieces of calcium, valve and aortic tissue, myocardium, or other organic or foreign matter.
➢ One in four patients have an average of 25 pieces of debris >0.5 mm headed to the brain5. Debris of this size has the potential to occlude cerebral arteries. Cerebral ischemic damage occurs in almost all patients undergoing TAVI1
➢ In addition to all clinical stroke and TIA, cerebral ischemic damage is also an important risk factor for subsequent clinical stroke, dementia, cognitive decline, and mortality. Debris captured during TAVI cases
South India's first procedure of SENTINEL™ Cerebral Protection System
Dr. G. Sengottuvelu Senior Consultant & Interventional Cardiologist and his team, Apollo Hospitals Chennai, successfully completed a procedure using the SENTINEL™ Cerebral Protection System, a new technology shown to help protect patients from the risk of stroke during a minimally invasive heart valve procedure. The technology was used for a transcatheter aortic valve implantation (TAVI) on a high risk 89-year-old male patient. Apollo Hospitals Chennai is the first healthcare institution in South India to use this protected TAVI /TAVR technology.
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