title: Application of Investigational Device Exemptions regulations to endograft modification.
abstract: For patients with complex aortic aneurysms that cannot be treated effectively with currently approved endografts, physicians have made fenestrations in marketed devices and constructed branched grafts by creatively implanting available endograft components. For the most part, these procedures are being done outside of clinical studies by individual physicians. Although these novel approaches may be useful in the treatment of individual patients, the current ad hoc use of physician-created fenestrated and branched devices may not result in the unbiased capture and reporting of data regarding short- and longer-term outcomes. As a result, unsubstantiated conclusions regarding the safety and effectiveness of these procedures may be drawn. Well-designed and executed clinical studies are necessary to adequately assess the benefits and risks of these techniques. Because these interventions involve the use of significant risk devices, these studies need to be conducted under United States Food and Drug Administration-approved Investigational Device Exemptions (IDE) applications. Although this regulatory process adds complexity to the application of these creative techniques, the IDE regulations assure that patient protection measures are followed and data are captured to assess safety and effectiveness. This approach creates opportunities to advance the development of innovative, beneficial devices and procedures to treat complex aortic aneurysms.
authors: United States Food and Drug Administration, Silver Spring, MD, USA. dorothy.abel@fda.hhs.gov
authors: Dorothy
authors: D
authors: Abel
authors: Andrew
authors: A
authors: Farb
mesh_terms: D001014:Aortic Aneurysm / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D057176:Compassionate Use Trials; D018795:Device Approval; D004059:Diffusion of Innovation; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D019317:Evidence-Based Medicine; D006801:Humans; D061214:Patient Safety; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration