Gore Nabs PFO-Closure Approval For Stroke
Executive Summary
WL Gore's Cardioform Septal Occluder is now the second device to gain PMA approval to close the patent foramen ovale heart defect, to help prevent repeat ischemic stroke, according to FDA's website.
You may also be interested in...
Global Device Approvals, Weekly Snapshot: March 26-April 1, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
Positive Long-Term Data Plug Doubts Over PFO-Closure Stroke Benefits
Data from the REDUCE, CLOSE, and RESPECT trials, published in the New England Journal of Medicine, showed that closing a patent foramen ovale with a percutaneous closure device can reduce the risk of ischemic stroke in patients who have already had a cryptogenic stroke. Observers believe these trials showed a benefit of PFO closure in this population after previous trials failed to show a benefit largely because they did a better job of only selecting patients most likely to benefit.
Gore's PFO Closers REDUCE Recurrent Ischemic Strokes By 77% In Trial
REDUCE is the first trial of patent foramen ovale closure device to show statistically significant reduction in stroke recurrence in its primary intent-to-treat analysis. The results, presented at the European Stroke Organisation Conference in Prague, will support Gore's application for Cardioform to the US FDA by the end of the year.