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The Pipeline™ Flex with Shield Technology™ Embolization — An International MulticEnter ObservationaL Post-Market StuDy (SHIELD) and Pipeline™ Flex Embolization Device with Shield Technology™ (PFLEX) were prospective, single arm, multicenter, post-market, observational studies evaluating the Pipeline™ Flex Embolization Device with Shield Technology™. An analysis of 159 patients with wide-necked aneurysms located in the internal carotid artery (ICA) was conducted to assess the safety and efficacy of the Pipeline™ Flex Embolization Device with Shield Technology™ in these real-world studies.
The findings of the integrated analysis of the SHIELD and PFLEX studies indicate that the Pipeline™ Flex Embolization Device with Shield Technology™ offers high occlusion rates, low neurologic morbidity and mortality and low device and procedure complication rates, for the treatment of intracranial aneurysms.
PREMIER (PRospective study on EMbolization of Intracranial anEuRysms with the Pipeline™ device) was a multi-center, prospective, interventional, single-arm trial to evaluate the safety and effectiveness of the Pipeline™ device* in the treatment of unruptured wide-neck intracranial aneurysms, measuring ≤ 12 mm, located in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery in 141 subjects.
Primary Safety Endpoint: Occurrence of major stroke in the territory supplied by the treated artery or neurological death at 1-year post-procedure.
Primary Efficacy Endpoint: Complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1-year post-procedure.
The PREMIER study is the first prospective, multicenter trial to evaluate the use of the Pipeline™ Flex* device for the treatment of small and medium, unruptured aneurysms of the intracranial carotid and proximal vertebral arteries. The findings from the PREMIER study provide evidence that treatment of wide-necked, small and medium intracranial aneurysms measuring ≤ 12 mm located in the ICA (up to the terminus) and proximal vertebral artery segment up to and including the posterior inferior cerebellar artery treated with the Pipeline™ device results in:
PUFs (Pipeline™ Embolization Device for Uncoilable or Failed Aneurysms) was a multicenter, prospective, interventional, single-arm trial to evaluate the safety and effectiveness of the Pipeline™ implant† in the treatment of complex intracranial aneurysms.
PUFs studied 108 subjects with a wide-necked, large, or giant intracranial aneurysm in the petrous, cavernous, or paraophthalmic regions of the internal carotid artery.
Treatment of large and giant aneurysms in the internal carotid artery (ICA) with the Pipeline™ device is safe and effective.
The PREMIER study included the Pipeline™ Embolization Device and Pipeline™ Flex Embolization Device. The Pipeline™ Flex Embolization Device contains the same implant as the Pipeline Embolization Device.
The PUFs study only included the Pipeline™ embolization device. The Pipeline™ Flex embolization device contains the same implant as the Pipeline™ embolization device.
Results may vary. Not all patients receive the same results.
PMA- P100018-S011, PMA-P100018-S026
Scientific Communication Document search (2018) showing clinical summaries. No other studies meet these criteria.
PREMIER Clinical Study Report Medtronic FD3563 Rev B. 12-SEP-2018.
Becske T. et al., Five-Year Results of the Pipeline™ for Uncoilable or Failed Aneurysms Trial. Neurosurgery (JNS). Published online Jan. 06, 2017.
Medtronic Internal Report, D00220076 Rev. A: Integrated Analysis of Clinical Outcomes using Pipeline™ with and without the Shield Surface Modification