INSPIRE Pipeline™ Shield Post Approval Study

Ki vehet részt

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
• Patient is intended to receive or be treated with an eligible Medtronic product
• Patient is consented within the enrollment window of the therapy received, as applicable
• Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR)
• Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU)

Ki nem vehet részt

• Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness)
• Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic
• Patient who is, or is expected to be, inaccessible for follow-up
• Participation is excluded by local law
• Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
• Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU
• The Investigator determined that the health of the patient may be compromised by the patient's enrollment