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Feasibility of Sentinel Cerebral Embolic Protection Device Deployment During Transfemoral Transcatheter Aortic Valve Replacement
Cerebral embolic protection has emerged as a preventive measure for procedural stroke in transcatheter aortic valve replacement (TAVR).1 The Sentinel System (Boston Scientific Corp. Boston, Massachusetts), a 2-filter debris-capturing system, has been the only commercially available protection device in the United States since its approval by the Food and Drug Administration in 2017. In the Sentinel trial, the largest randomized trial (n  = 363) so far, the device was successfully deployed in 94.7% of patients.
Source: The American Journal of Cardiology - October 1, 2022 Category: Cardiology Authors: Toshiaki Isogai, Husitha Reddy Vanguru, Amar Krishnaswamy, Ankit Agrawal, Nikolaos Spilias, Shashank Shekhar, Anas M. Saad, Beni Rai Verma, Rishi Puri, Grant W. Reed, Zoran B. Popovi ć, Shinya Unai, James J. Yun, Ken Uchino, Samir R. Kapadia Source Type: research

Impact of Hospital Volume on Utilization and Outcomes of Sentinel Cerebral Protection System During Transcatheter Aortic Valve Implantation
Stroke remains a serious complication of transcatheter aortic valve implantation (TAVI) with a significant impact on long-term morbidity and mortality. Although the etiology of strokes is multifactorial, most are a result of embolization of debris during the procedure.1 Multiple devices have emerged aiming to reduce the incidence of stroke through cerebral embolic protection. The Sentinel cerebral protection system (CPS) is the only Food and Drug Administration-approved device in the United States.
Source: The American Journal of Cardiology - July 13, 2022 Category: Cardiology Authors: Agam Bansal, Toshiaki Isogai, Mohamed M. Gad, Grant W. Reed, Rishi Puri, Amar Krishnaswamy, Samir R. Kapadia Source Type: research

Overview of the 2016 US Food and Drug Administration Circulatory System Devices Panel Meeting on the Amplatzer Patent Foramen Ovale Occluder
On May 24, 2016, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to consider a premarket approval (PMA) application for the Amplatzer Patent Foramen Ovale (PFO) Occluder based on the results of the pivotal RESPECT trial1. In this prospective randomized multicenter open-label trial, patients with a prior cryptogenic stroke and a PFO were randomized 1:1 to “best” medical therapy or PFO closure using the Amplatzer PFO Occluder with at least 6 months of post implant antiplatelet therapy.
Source: The American Journal of Cardiology - September 28, 2016 Category: Cardiology Authors: Toby Rogers, Michael Slack, Ron Waksman Source Type: research

Problems in addition to stroke and bleeding after left atrial appendage closure
We read the article by Waksman et al. about the discussions between the US Food and Drug Administration (FDA) and the sponsor regarding approval of the WATCHMAN-device for interventional left atrial appendage closure (LAAC).[1] We would like to stimulate the discussion by the following contribution: LAAC is primarily intended as an alternative for stroke prevention in patients with atrial fibrillation (AF) in whom oral anticoagulation (OAC) is not possible because of contraindications about a high bleeding risk.
Source: The American Journal of Cardiology - April 24, 2015 Category: Cardiology Authors: Claudia Stöllberger, Josef Finsterer, Birke Schneider Source Type: research

Reply
We appreciate the interest in our article, “Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN Left Atrial Appendage Closure Therapy,” and that it stimulated provocative discussion in a letter to the editor. First, the WATCHMAN device was approved with the indication to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation, who are at an increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores; are deemed by their physicians to be suitable for warfarin; and have an appropriat...
Source: The American Journal of Cardiology - April 23, 2015 Category: Cardiology Authors: Ron Waksman Source Type: research

Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN™ Left Atrial Appendage Closure Therapy
The WATCHMAN (Boston Scientific Corp, Maple Grove, MN) left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with non-valvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a “Not Approvable” letter was issued by the US Food and Drug Administration (FDA) based on safety concerns.
Source: The American Journal of Cardiology - November 11, 2014 Category: Cardiology Authors: Ron Waksman, Lakshmana K. Pendyala Source Type: research

Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN Left Atrial Appendage Closure Therapy
The WATCHMAN left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with nonvalvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a “not approvable” letter was issued by the US Food and Drug Administration (FDA) based on safety concerns.
Source: The American Journal of Cardiology - November 11, 2014 Category: Cardiology Authors: Ron Waksman, Lakshmana K. Pendyala Tags: Review Source Type: research