Transcatheter Aortic Valve Replacement (TAVR)

Recent studies have shown that almost 1 in 10 TAVR patients show overt signs of ischemic brain injury as a result of TAVR procedure.1 The Sentinel Cerebral Protection System (CPS) has been shown to reduce strokes by 63% in the first 72 hours after TAVR, when most strokes occur2 and is corroborated by a reduction in TAVR stroke, and stroke or mortality by 70%.3 In clinical studies, Sentinel CPS removed visible debris headed towards the brain in 99% of TAVR cases,1 regardless of replacement valve used and with virtually no added risk.

Simple and Safe

The Sentinel has been found safe and compatible to use with all commercially-available TAVR valves.1 It is simple to use, and has demonstrated 99% deployment success in a median deployment time of four minutes.1

Sentinel CPS is securely positioned away from the aortic arch, avoiding extended contact with potentially calcified tissue, minimizing interference with TAVR catheters, and enabling physicians to put all their focus on the TAVR procedure itself.

Leading the Way Investing in Clinical Evidence

Study Principal Investigator Location # Patients Trial Type Procedure Data
First in Man Prof. Christoph Naber 3 centers in Brazil & Germany 40 Registry TAVI
(CoreValve & Sapien)
EuroIntervention
March 2012
MISTRAL-I Dr. Nicolas van Mieghem Rotterdam, Netherlands 40 Registry TAVI
(CoreValve & Sapien)
Circulation
October 2013
CLEAN-TAVI Prof. Axel Linke Leipzig University, Germany 100 Randomized TAVI (CoreValve) JAMA
August 2016
MISTRAL-C Dr. Nicolas van Mieghem 4 centers in Netherlands 74 Randomized TAVI
(Sapien 3)
EuroIntervention July 2016
SENTINEL IDE Drs Susheel Kodali, Samir Kapadia, & Prof. Axel Linke 17 centers in USA & 2 in Germany 363 Randomized TAVI
(Sapien XT, Sapien 3, CoreValve, EvolutR)
JACC
January 2017
SENTINEL-H Prof. Christoph Naber 10 centers in Europe 220 Registry TAVR
(All-comers)
Presented at
EuroPCR 2016

References

  1. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377.
  2. Data from SENTINEL Trial, included in device’s Instructions for Use (IFU). To view IFU, click here.
  3. To view Ulm registry results in JACC CVI, click here.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Click here for the Indication, Contraindications, Warnings, and Precautions.