Embedded Files
Medicare & Medicaid Services has identified endografts as nonexperimental/investigational devices and is more likely to reimburse for studies that are conducted in an approved IDE protocol. How do these regulatory requirements translate to frequently asked clinical questions? Question: In an emergency, can an off-label modified endograft be used without additional requirements? Yes, a physician has the discretion to recommend any treatment if it is judged to be in the patient's best interest. Compassionate-use approvals can also be used for planned novel treatment of conditions not amenable to conventional treatment. Compassionate use requires IRB approval and, in addition, may require FDA and manufacturer approval. Serial planned use of modified endografts is not compassionate use. If serialuse is planned, IRB and IDE approvals are required. Local IRBs have different rules, and some require that elective one-time compassionate use be approved by an IRB chair using the expedited route, but if that chair is uncomfortable with making the decision, it can be sent for full IRB review. Clinical studies of modified aortic endografts must have IRB and IDE approval.Refer to: Question: How does one consent a patient for modification of a commercial endograft? Modified aortic endografts should only be used within a study that has been approved by an IRB and the FDA to determine the safety and effectiveness of these devices. The IRB and the FDA both review the draft informed consent forms to ensure that the study patients are appropriately informed of their rights, safety, and welfare. Question: Can an IRB grant approval to perform modification of an aortic endograft without requiring FDA approval? The IRB can only grant approval and not require FDA approval if it believes a study is not a significant-risk study. As mentioned, because all aortic endovascular graft studies using modifications of approved devices are significant-risk studies, IRB and FDA approval are both required before elective modification and use of a device. Question: How can I train for a new unapproved modification of an aortic endograft procedure?Until the safety and effectiveness of each type of endograft device modification is confirmed, training is not recommended. Training in the context of an approved fellowship in an institution that has an approved IDE is acceptable.Question: Can presentations at meetings and publication of papers describing novel modified aortic endograft treatments be made if patients were treated outside of an approved IDE? Presentations of one-time emergency use or compassionate use are acceptable. If a report of a clinical series is prepared, the IRB and IDE approval status should be clearly described. Question: How do I apply for an IDE if I want to prospectively treat patients with complex anatomy using modified commercially available aortic endografts devices? Contact your IRB and ask how to prepare a submission to evaluate the risk of your proposed study and how to prepare an IDE. Independent peer-review and oversight has been provided by members of the SVS Document Oversight Does the endovascular repair of aortoiliac aneurysms pose a radiation safety hazard to vascular surgeons?*,** Presented at the Twenty-eighth Annual Symposium on Vascular Surgery, Society for Clinical Vascular Surgery, Rancho Mirage, Calif, Mar 15-19, 2000. Objectives: Endovascular aortoiliac aneurysm (EAIA) repair uses substantial fluoroscopic guidance that
Report abuse