FDA Advisory Panel Will Consider Cordis Incraft AAA Stent Graft
May 16, 2018—The US Food and Drug Administration's (FDA's) announcement of the public advisory committee meeting of the Circulatory System Devices Panel of the forthcoming Medical Devices Advisory Committee was published in the Federal Register on May 11. The meeting will be open to the public and will be held on June 12, 2018, from 8 am to 6 pm at the Hilton Washington, DC North/Gaithersburg, Maryland.
The general function of the committee is to provide advice and recommendations to the agency on FDA's regulatory issues.
Specifically, the committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Cordis, a Cardinal Health company, for its Incraft abdominal aortic aneurysm (AAA) stent graft system. The Incraft device is intended for the endovascular treatment of infrarenal AAAs in patients with appropriate anatomy. The Incraft device is being evaluated in the multicenter, prospective, nonrandomized INSPIRATION study.
As noted in the FDA announcement, the INSPIRATION study met its primary safety and effectiveness endpoints, but results also showed higher than anticipated rates of certain adverse events. The committee discussion will focus on how these events impact the long-term safety and effectiveness of the device, as well as the benefit/risk profile.
The FDA advised that interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 5. Oral presentations from the public will be scheduled on June 12 between approximately 1 pm and 2 pm. Individuals interested in making formal oral presentations should notify the FDA contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present on or before May 25. More information is available in the Federal Register announcement here.