Cardinal Health’s Cordis wins date with FDA panel for Incraft AAA stent graft

This article was originally published here

Cardinal Health (NYSE:CAH) subsidiary Cordis this week won a June date with an FDA panel looking to discuss the premarket approval application for its InCraft AAA stent graft system designed for treating infrarenal abdominal aortic aneurysms.

On June 12, the FDA’s Medical Device Advisory Committee’s Circulatory Systems Devices Panel will meet to discuss possible marketing applications for the InCraft, which is currently under evaluation in the company’s Inspiration study.

The Inspiration study has already met its primary safety and effectiveness endpoints, but reported a higher than anticipated rate of certain adverse events, according to an FDA release.

In meeting, the FDA panel will explore “how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile of the device,” according to the release.

Shares in Cardinal Health have risen 5.1% so far today, at $55.47 as of 12:06 p.m. EDT.

Last month, the US Court of Appeals for the Federal Circuit revived a stent patent infringement suit brought by Medinol against Cordis  and its former parent company Johnson & Johnson (NYSE:JNJ).

The post Cardinal Health’s Cordis wins date with FDA panel for Incraft AAA stent graft appeared first on MassDevice.

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