Publications and Conferences
Claret Medical’s Cerebral Protection System is designed to filter, capture and remove embolic debris that may otherwise travel to the brain during TAVR, other catheter-based, cardiovascular procedures and surgical cardiovascular procedures. Its proprietary filter-based system has been evaluated in numerous studies to date and it is currently being studied to determine its role in reducing the number and volume of new cerebral lesions created by debris lodged in the brain during endovascular structural heart interventions.
CRT (Cardiovascular Research Technologies)
DATE: February 18-21, 2017
LOCATION: Washington, D.C.
Cerebral Embolic Protection Devices Session
CO-MODERATORS: E. Grube and A. Linke
PRESENTERS: E. Grube, S. Kapadia, A. Lansky, M. Mack, LN Hopkins
PANELISTS: M. Dwyer, E. Grube, M. Mack, R. Makkar, A. Pichard, B. Rutkin
DATE: Monday, February 20, 2017
LOCATION: Room Blue
LINC (Leipzig Interventional Course)
DATE: January 24-27, 2017
LOCATION: Leipzig, Germany
Preventing strokes in TEVAR: What factors should be considered?
PRESENTER: M. Hamady
DATE: Tuesday, January 24, 2017
LOCATION: Room 4 – Discussion Forum
JIM (Joint Interventional Meeting)
DATES: February 9-11, 2017
LOCATION: Milan, Italy
ACC (American College of Cardiology)
DATES: March 17-19, 2017
LOCATION: Washington, D.C.
DGK (German Cardiac Society)
DATES: April 19-22, 2017
LOCATION: Mannheim, Germany
- Giustino G, et al. Cerebral Embolic Protection During TAVR: A Clinical Event Meta-Analysis. JACC 2017; 69(4):465-6
- Kapadia, S et al. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. JACC 2017;69(4):367–77
- Latib, A and Pagnesi, M Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: A Disconnect Between Logic and Data? JACC 2017;69(4):378-80
- Dangas, G and Giustino, G Art and Science of Cerebrovascular Event Prevention After Transcatheter Aortic Valve Replacement Circ Cardiovasc Interv. 2016;9:e004307
- Haussig, S et al. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis. JAMA 2016;316(6)592-601
- van Mieghem, N et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomized MISTRAL-C trial. EuroIntervention 2016;12:499-507
- Schmidt, T et al. Heart Histology of debris captured by a cerebral protection system during transcatheter valve-in-valve implantation. Heart 2016;0:1-7
- Frerker, C et al. Cerebral Protection During MitraClip Implantation. J Am Coll Cardol Intv 2016: Article In Press
- Meincke, F et al. Rationale of cerebral protection devices in left atrial appendage occlusion. Catheter Cardiovasc Interv. 2016 Oct 20. doi: 10.1002/ccd.26677. [Epub ahead of print]
- Schmidt, T et al. Histological Findings and Predictors of Cerebral Debris From Transcatheter Aortic Valve Replacement: The ALSTER Experience. J Am Heart Assoc. 2016;5:e004399 doi: 10.1161/JAHA.116.004399)
- Ghanem, A et al. Mechanisms And Prevention Of TAVI-Related Cerebrovascular Events. Current Pharmaceutical Design, 2016, 22, 000-000
- Kahlert, P et al. Silent Cerebral Ischemia After Thoracic Endovascular Aortic Repair: A Neuroimaging Study. Ann Thorac Surg 2014;98:53–8
- van Mieghem N et al. Incidence and Predictors of Debris Embolizing to the Brain During Transcatheter Aortic Valve Implantation. J Am Coll Cardiol Intv. 2015;8:718-24
- van Mieghem N et al. Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement. Circulation. 2013;127:2194-2201
- Naber CK et al. First-in-Man Use of a Novel Embolic Protection Device for Patients Undergoing Transcatheter Aortic Valve Implantation. EuroIntervention. 2012;8(1):43-50
- TCT 2016
- Kodali S. SENTINEL: A Prospective, Randomized Trial Evaluating Cerebral Protection in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
- Linke, A. The Sentinel filter – design features and updates from CLEAN-TAVI, SENTINEL RCT, and others
- Leon M. Spectrum and Assessment of TAVR accessory devices (valvuloplasty balloons, neuroprotection systems and more)
- Kapadia S. TAVR Complications: Strokes and TAVR: Is stroke frequency declining?
- Kapadia S. TAVR Controversies: Is cerebral protection needed for TAVR? Observations from DEFLECT 3, CLEAN TAVI, and the SENTINEL clinical trials
- Linke A. Flash Debate: Cerebral protection is a “must” for all patients!
- Claret TCT 2016 Symposium: SENTINEL Science: compelling new evidence for cerebral protection in TAVR
- Linke A. Agenda and Objectives
- Kapdia S., Makkar R. Key findings from the landmark SENTINEL pivotal trial
- Dwyer M., Linke A. New neuroimaging insights into the predictors of cerebral ischemic insult during TAVR
- Lazar R., Browndyke J. Observations from the neurocognitive function substudy of the SENTINEL trial: clinical implications
- Leon M. Closing comments
- TVT 2016
- van Mieghem N. The Sentinel Dual Filter Device: Design Features and EU Clinical Trial Results.
- Kodali S. The Sentinel US Pivotal Clinical Trial Design.
- Kodali S. The Case For and Against Cerebral Embolic Protection During TAVR.
- Kapadia S. Stroke After TAVR: Etiologies, Declining Frequency, and Current and Future Therapies.
- EuroPCR 2016
- Jensen C. Prevalence and etiopathology of thrombembolic debris during transcatheter interventional aortic valve replacement: preliminary results of the SENTINEL-H study.
- Pagnesi, M. Silent cerebral injury after TAVI and the preventive role of embolic protection devices: a systematic review and meta-analysis.
- ACC 2016
- CRT 2016
- LINC 2016
- TCT 2015
- van Mieghem N. MISTRAL-C: A Prospective Randomized Trial of Embolic Protection During Transcatheter Aortic Valve Replacement
- Linke A. Cerebral Embolic Protection Devices: Sentinel Dual Filter Device Technology Review and CLEAN-TAVI Results
- Schmidt T. Cerebral Protection Device for Transcatheter Valve-in-Valve Procedures – The ALSTER Data
- Kapadia S. Neuroprotection During TAVR
- Schmidt T. Experience With Cerebral Protection During Transcatheter Aortic Valve Replacement – The ALSTER Registry
- Meincke F. Cerebral protection for LAA: Claret Safety and Histopath
- Kodali S. Cerebral Embolic Protection Devices: Sentinel Dual Filter Device – Update of US Pivotal Clinical
- Kapadia S. Reassessing Incidence (Declining), Etiologic Factors, and Remaining Controversies
- van Mieghem N. Need for Cerebral Protection (Universal vs Selective)
- Lazar R. Importance and Methods of Neurocognitive Functional Assessments
- London Valves 2015
- Baumbach A. Thromboembolism and Stroke After TAVI – What Are The Issues?
- Lansky A. Neurologic Complications of Contemporary Unprotected Trans-Aortic Valve Replacement: Final Results of a Prospective MultiCenter Study to Evaluate the Neuro-Embolic Consequences of TAVR in the United States (The Neuro-TAVR Trial)
- van Mieghem M. Incidence and Predictors of Debris Embolizing to The Brain During TAVI
- CSI 2015
- TVT 2015
- Grube E. Cerebral Protection Devices are Still Meaningful and Necessary
- Kapadia S. Strokes after TAVR
- EuroPCR 2015
- Haussig S. How to Decrease the Risk of Stroke
- Wenaweser P. How to Prevent Thromboembolic Complications in TAVI
- Kuck K-H. TAVR Stroke Session Summary
- Van Mieghem N. Cerebral Protection in TAVI: Theory and Practice (Interview)
- ACC 2015
- Dallas-Leipzig Valve 2014
- London Valves. 2014
- TCT 2014
- Linke A. CLEAN-TAVI: A Prospective, Randomized Trial of Cerebral Embolic Protection in High Risk Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
- Leon M. Sentinel Dual Filter Device: Technology Overview and Status of the CLEAN-TAVI Randomized Trial
- Kapadia S. TAVR Complications I – Strokes and Paravalvular Regurgitation
- van Mieghem N. Strokes After TAVR II: Management Considerations (Current and Future)
- Lazar R. Aortic Valve Therapies – Today and Tomorrow II, Neurocognitive Functional Assessment After TAVR: Methodologies and Clinical Importance
- Kodali S. Cerebral Protection in Transcatheter Aortic Valve Replacement: The SENTINEL Study
- TVT 2014
- Grube E. Why Cerebral Protection After TAVR Will Become the Standard of Care.
- Leon M. Stroke Basics After Cardiovascular Interventions: VARC 2 Definitions, Stroke Severity Assessment, Neuroimaging, and Neurocognitive Function
- Linke A. A Critical Analysis of Present Data on Cerebral Protection After TAVR
- van Mieghem N. Histopathology Debris Analysis and Status of MISTRAL-C Randomized Trial
- DGK 2014
- Schäfer U, Thielsen T, Schewel D, Schewel J, Spangenberg T, Kuck K, Frerker C. Embolic Protection During Transcatheter Aortic Valve Implantation with the Claret Montage™ Filtration System
Claret Medical technology is the only cerebral protection system that has consistently been used in TAVI teaching conference ‘live-cases’ in the last two years. This is a testimony to Sentinel’s ease of use, speed of deployment and minimal disruption of the TAVI implantation.
- EuroPCR 2015
- TVT 2015
- TAVR Highlighting Sentinel Cerebral Protection System. (Columbia University/New York Presbyterian Hospital, New York)
- TAVR left axillary access with Symetis Acurate Neo valve. (University Heart Center, Hamburg)
- Valve-in-Valve with Lotus. (University Heart Center, Hamburg)
- TCT 2014
- Lazar R. The Role of Cerebral Protection in TAVR and Other Cardiovascular Procedures: Implications of ‘Silent’ Cerebral Ischemia for Neurocognitive Function.
- Zivadinov R. The Role of Cerebral Protection in TAVR and Other Cardiovascular Procedures: Implications of DW-MRI and FLAIR Signals from Clinical Studies.
The Sentinel CPS has received the CE Mark and is commercially available in Europe. It is limited to investigational use in the United States.