Forbes

Should Patients Be Able To Receive "PFO Occluders" Outside Of Research Trials?

Ten years ago, my tennis partner suffered a stroke. He was a sixty-year-old at the time, working to move up into the top ten players in his age group. In the country! You could not have found a ...
TCTMD

FDA Approves GORE® CARDIOFORM Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke

FLAGSTAFF, Ariz. Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc.
RAPS

FDA Approves First PFO Occluder From St. Jude

The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who ...
Yahoo Finance

Occlutech Continues its Progress in US FDA Study OCCLUFLEX – Enrolls First Patient in Europe

SCHAFFHAUSEN, CH / ACCESSWIRE / January 31, 2023 / Occlutech Holding AG Occlutech Holding AG ("Occlutech"), one of the world's leading providers of minimally invasive structural heart disease devices, ...
Nature

Can patent foramen ovale closure using the Cardia PFO occluder reduce the occurrence of thromboembolic events?

Data indicate that there could be a link between cryptogenic thromboembolic events and patent foramen ovale (PFO). Although controversial, increasing numbers of patients are undergoing transcatheter ...
TCTMD

FDA Approves Amplatzer PFO Occluder for Prevention of Recurrent Stroke

Ending a decades-long wait, the US Food and Drug Administration (FDA) today approved the Amplatzer PFO Occluder device (St. Jude Medical) for recurrent stroke prevention in patients with a patent ...
Yahoo Finance

Occlutech Progress in US – First Patient has been Enrolled in Important US FDA Study

Occlutech Holding AG ("Occlutech"), one of the world's leading providers of minimally invasive structural heart disease implants, continues its progress in the US market. The company announce today ...
Medindia

Occlutech Obtains CE Mark for its "Figulla N" ASD and PFO Occluders

JENA, Germany, October 17 Occlutech GmbH, the leadingEuropean developer and manufacturer of cardiac occlusion devices such as ASD,PFO and LAA occluders today announced that it has received CE mark ...
Medscape

After RESPECT and PC Trial: What Role for PFO Closure?

MIAMI – The Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) and PC Trial were both presented last week at TCT 2012 after ...
Medscape

No shortcuts: FDA panel says PFO occluders must prove themselves in RCTs, no matter how long it takes

The only way you can possibly answer the question is through some kind of randomized clinical trial. "It's clear the panel thinks that for PFO closure for first cryptogenic stroke [in the presence of] ...
Medindia

FDA Approves GORE® CARDIOFORM Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke

FLAGSTAFF, Ariz., April 3, 2018 /PRNewswire/ -- Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W.