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Use of a NobleStitch ™ EL Device for PFO Closure.
Use of a NobleStitch™ EL Device for PFO Closure. Surg Technol Int. 2018 Jun 01;32:219-223 Authors: de Cillis E, Acquaviva T, D'Alessandro P, Bortone AS Abstract Cryptogenic stroke is the final diagnosis in almost 40% of ischemic acute cerebrovascular events. There is currently no definitive clinical evidence that percutaneous closure of patent foramen ovale (PFO) can prevent the recurrence of stroke or transient ischemic attack (TIA). Identification of the causes of neurologic ischemic syndromes is essential for any strategy intended to prevent the catastrophic consequences of cerebral infarction. Sin...
Source: Surgical Technology International - May 25, 2018 Category: Surgery Tags: Surg Technol Int Source Type: research

The Reply
We recently reported an updated meta-analysis of 5 randomized clinical trials demonstrating that transcatheter closure of patent foramen ovale reduces the risk of recurrent neurologic events compared with medical therapy after cryptogenic stroke.1 Key trials have collectively studied more than 10 different patent foramen ovale closure devices, including the US Food and Drug Administration –approved AMPLATZER PFO Occluder (Abbott Vascular, Santa Clara, Calif). These devices vary considerably in material, size, and profile and differ with respect to procedural deployment.
Source: The American Journal of Medicine - May 19, 2018 Category: General Medicine Authors: Muthiah Vaduganathan, Arman Qamar, Ankur Gupta, Navkaranbir Bajaj, Harsh B. Golwala, Ambarish Pandey, Deepak L. Bhatt Tags: Letter Source Type: research

The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke Advances in Interventional Cardiology
Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale [PFO]), and CLOSE (Patent For...
Source: Circulation: Cardiovascular Interventions - March 16, 2018 Category: Cardiology Authors: Wiktor, D. M., Carroll, J. D. Tags: Secondary Prevention, Treatment, Ischemic Stroke Advances in Interventional Cardiology Source Type: research

Patent foramen ovale closure to prevent secondary neurologic events.
Abstract In October of 2016 the United States Food and Drug Administration approved the Amplatzer Patent Foramen Ovale (PFO) occluder device for use in patients with cryptogenic stroke, to reduce the risk of recurrent stroke. This event followed 15years of off-label use of atrial septal occluder devices, 3 randomized trials, and enormous controversy over the efficacy of this procedure. While none of the trials reached the primary endpoint needed to prove the efficacy of PFO closure in preventing recurrent stroke, meta-analyses and 5-year follow-up of 1 trial suggest that PFO closure decreases the risk of recurrent...
Source: European Journal of Internal Medicine - July 3, 2017 Category: Internal Medicine Authors: Jasper R, Blankenship JC Tags: Eur J Intern Med Source Type: research

PFO Closure for Cryptogenic Stroke: A Review and Clinical Treatment Algorithm
We describe the historical context of PFO closure and review the observational and randomized control trial evidence in this field, culminating in the recent Food and Drug Administration approval of the first dedicated closure device for PFO. Guidelines and consensus statements are discussed, and a novel treatment algorithm is proposed. Future directions in PFO closure will include new devices, further data from completed and upcoming clinical trials, and potential expansion into other disease states associated with PFO.
Source: Cardiology in Review - June 6, 2017 Category: Cardiology Tags: Review Articles 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

Patent Foramen Ovale and Cryptogenic Stroke: The Hole Story Emerging Therapy Critiques
Despite 3 recent randomized clinical trials, the management of patients with cryptogenic stroke and patent foramen ovale remains unsettled. The primary results of Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale (CLOSURE), Percutaneous Closure of Patent Foramen Ovale in Cryptogenic Stroke (PC), and Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) were the same; the intent to treat analysis for the primary end point in all 3 ...
Source: Stroke - August 26, 2013 Category: Neurology Authors: Furlan, A. J., Jauss, M. Tags: Other Stroke Treatment - Medical, Other Stroke Emerging Therapy Critiques Source Type: research