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Gore Nabs PFO-Closure Approval For Stroke

 
• By David Filmore

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.

With a new US FDA approval in hand, WL Gore & Associates Inc. is updating its labeling and getting set to market itsCardioform Septal Occluderto close a heart defect called the patent foramen ovale (PFO) as a means to reduce the risk of recurrent ischemic stroke.

A PMA supplement approval was granted March 30 for the PFO indication, according to a new listing in FDA'sPMA approvals database. The device is already on the market for...

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More from Policy & Regulation

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• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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