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Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients. The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy. “With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news

ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts. The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects. “It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news

Endocarditis Is a Common Stroke Mechanism in Hemodialysis Patients Brief Reports
Conclusions— Cardioembolism and cryptogenic stroke are the predominant stroke mechanisms among hemodialysis patients. Infective endocarditis was identified frequently relative to other stroke cohorts, and a raised index of suspicion is warranted in the hemodialysis population.
Source: Stroke - March 24, 2014 Category: Neurology Authors: Ishida, K., Brown, M. G., Weiner, M., Kobrin, S., Kasner, S. E., Messe, S. R. Tags: Echocardiography, Embolic stroke Brief Reports Source Type: research