US Approvals Analysis: Stroke Device, IVDs Highlight October FDA Actions
Executive Summary
A PFO-closure device was finally approved for stroke in October. Also during the month, important personalized medicine diagnostics approvals and a next-gen robotic system for stent procedures.
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Gore Nabs PFO-Closure Approval For Stroke
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.
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.
Genentech’s Tecentriq Stakes New Claim With FDA Lung Cancer Approval
Genentech’s PD-L1 inhibitor Tecentriq could steal market share from the PD-1 inhibitors Opdivo and Keytruda in its new indication, but the Roche subsidiary’s drug is a year behind competitors from Bristol-Myers and Merck in NSCLC with seven Phase III trials under way to expand its reach in lung cancer.