GORE(R) CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects

Data from the Gore ASSURED Clinical Study demonstrated 100 percent closure success at six months FLAGSTAFF, Ariz., June 4, 2019 -- (Healthcare Sales &Marketing Network) -- W. L. Gore &Associates (Gore) announced the U.S. Food and Drug Administration'... Devices, Interventional, Cardiology, FDA W. L. Gore, patent foramen ovale, CARDIOFORM, Septal Occluder
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news

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CONCLUSIONS: PFO closure should be considered on an individual basis. In particular, individuals who are healthy, have a significant DCS burden, a large PFO or seek to pursue advanced diving may benefit from closure. PMID: 31177513 [PubMed - in process]
Source: Diving and Hyperbaric Medicine - Category: Sports Medicine Tags: Diving Hyperb Med Source Type: research
Authors: Wilmshurst P Abstract In this issue, Anderson and colleagues report follow-up of divers who were found to have a persistent (patent) foramen ovale (PFO) or, in eleven cases, an atrial septal defect (ASD). In most divers diagnosis followed an episode of decompression illness (DCI). The efficacy of closure of the PFO/ASD in preventing future DCI was compared with conservative diving. They reported that in the closure group the occurrence of confirmed DCI decreased significantly compared with pre-closure, but in the conservative group this reduction was not significant. It is believed there are three requ...
Source: Diving and Hyperbaric Medicine - Category: Sports Medicine Tags: Diving Hyperb Med Source Type: research
The GORE CARDIOFORM Septal Occluder has been approved by the FDA to treat ostium secundum atrial septal defects (ASD) via percutaneous closure procedures. In a clinical study of the device in 125 patients with ASD, ranging in age from 2 to 84, all wh...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Radiology Source Type: blogs
The spatial relationship between atrial septal occluders and the aorta and the subsequent impact on the geometry and mechanics of the aortic root have been underinvestigated. The aim of this study was to evaluate occluder-aorta interaction after device closure of an atrial septal defect (ASD) or a patent foramen ovale (PFO) using three-dimensional transesophageal echocardiography and two-dimensional speckle-tracking echocardiography.
Source: Journal of the American Society of Echocardiography - Category: Cardiology Authors: Source Type: research
Abstract Background: Atrial septal aneurysm (ASA) is a congenital deformity of the interatrial septum with a prevalence of 1-2% in the adult population. Although ASA has been supposed to be an incidental finding in echocardiographic examination, its structural and clinical associations have gained an increasing interest. Aim: To investigate and compare the clinical features and echocardiographic parameters between ASA patients and age- and gender-matched control group patients. Methods: 410 patients with ASA were enrolled in the study, prospectively. After the exclusion of 33 patients, the remaining 377 ...
Source: Cardiology Research and Practice - Category: Cardiology Authors: Tags: Cardiol Res Pract Source Type: research
CONCLUSIONS: There was no consensus regarding the ability of patch testing to accurately determine allergic reactions within cardiac tissue. There was also no agreement on the criteria for patch testing in patients undergoing intracardiac implantation. However, most would inquire about a history of contact sensitivity to previously implanted devices. With a positive patch test, nickel-based intracardiac devices should be avoided, or the decision should be left to the discretion of the cardiologist. PMID: 31045931 [PubMed - as supplied by publisher]
Source: Dermatitis - Category: Dermatology Authors: Tags: Dermatitis Source Type: research
Source: Cardiovascular Intervention and Therapeutics - Category: Cardiology Source Type: research
AbstractPercutaneous closure of atrial septal defect (ASD)/patent foramen ovale (PFO) can influence systemic hemodynamics. The aim of this research was to evaluate the influence of the closure procedure on morphological and functional characteristics of systemic vascular walls. Fourteen ASD (mean age 40  ± 16 years) and 14 PFO (45 ± 8 years) patients were enrolled in this retrospective study. All underwent percutaneous closure procedure; physical, clinical and biochemical evaluations; echocardiography; carotid evaluation; and brachial artery flow-mediated vasodilatation (...
Source: Heart and Vessels - Category: Cardiology Source Type: research
This study reports our initial experience with robotic-assisted partial anomalous pulmonary venous connection (PAPVC) repair. From May 2013 through September 2018, 20 patients (12 male and 8 female) underwent robotic-assisted repair of a right-sided (n = 19) or a left-sided (n = 1) PAPVC. The mean age was 24.6 ± 9.4 years (range 14–44) and the mean body mass index was 22.3 ± 4.6. Seventeen patients had a right-sided supra-cardiac PAPVC with sinus venosus atrial septal defect, two had a right-sided cardiac PAPVC to the right atrium and one had ...
Source: Journal of Robotic Surgery - Category: Surgery Source Type: research
Publication date: March 2019Source: The Annals of Thoracic Surgery, Volume 107, Issue 3Author(s): Ryan J. Hendrix, Ricardo A. Bello, Julie M. Flahive, Nikolaos Kakouros, Gerard P. Aurigemma, John F. Keaney, William Hoffman, Christina M. VassilevaBackgroundIt has been postulated that mitral valve repair in the elderly does not confer short-term benefits over mitral valve replacement with complete preservation of the chordal apparatus. Our purpose was to test this hypothesis using data from The Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD).MethodsPatients aged 70 years or more undergoing primary isol...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
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