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.
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