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 has been shown to reduce strokes by 63% in the first 72 hours after TAVR, when most strokes occur.2 In clinical studies, the Sentinel 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
The Sentinel 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.
Key Sentinel Studies
|Study||Principal Investigator||Location||# Patients||Trial Type||Procedure||Data|
|First in Man||Prof. Christoph Naber||3 centers in Brazil & Germany||40||Registry||TAVR (CoreValve & Sapien)||EuroIntervention March 2012|
|MISTRAL-I||Dr. Nicolas van Mieghem||Rotterdam, Netherlands||40||Registry||TAVR (CoreValve & Sapien)||Circulation October 2013|
|CLEAN-TAVI||Prof. Axel Linke||Leipzig University, Germany||100||Randomized||TAVR (CoreValve)||JAMA August 2016|
|MISTRAL-C||Dr. Nicolas van Mieghem||4 centers in Netherlands||74||Randomized||TAVR (Sapien 3, Sapien XT, CoreValve)||EuroIntervention July 2016|
|SENTINEL* IDE||Drs Susheel Kodali, Samir Kapadia, & Prof. Axel Linke||17 centers in USA & 2 in Germany||363||Randomized||TAVR (Sapien XT, Sapien 3, CoreValve, EvolutR)||JACC November 2016|
|SENTINEL-H||Prof. Christoph Naber||10 centers in Europe||220||Registry||TAVR (All-comers)||Presented at EuroPCR 2016|
|TEVAR – Essen||Prof. R Alexander Jánosi||West German Heart & Vascular Center, Essen Germany||5||Pilot Study||TEVAR||Presented at LINC 2016|
|TEVAR – London||Drs Mo Hamady & Gagandeep Grover||Imperial College, London England||8||Pilot Study||TEVAR||Presented at ISET 2016|
|LAAO – Hamburg||Prof. Felix Meincke||AK St Georg, Hamburg Germany||5||Pilot Study||LAAO||Presented at TCT 2015|
|V-in-V||Dr. Tobias Schmidt and Dr. Christian Frerker||AK St Georg, Hamburg Germany||15||Registry||Aortic and Mitral
|BMJ May 2016|
*Commercially available valves in the US.
- Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377
- Data from SENTINEL Trial, included in device’s Instructions for Use (IFU). To view IFU, 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.