Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study

Abstract

Background and purposeThe Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer.Materials and methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes.ResultsFifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period.ConclusionsThe results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. Clinical trial registrationNCT02390037.

Safety and efficacy of the Derivo Embolization Device for the treatment of ruptured intracranial aneurysms

“…Based on our still limited experience, treatment of RIAs with the DED without adjunctive coiling is feasible and appears to be reasonably safe; however, these results need to be verified by larger series. In our study, immediate aneurysm occlusion was achieved in 9.1%, which is considerably lower than with conventional endovascular or surgical methods,19 but is comparable with other series on flow diverter treatment 11. However, among nine aneurysms with incomplete occlusion, immediate intra-aneurysmal contrast stasis was achieved in all cases.…”

Thrombogenicity assessment of Pipeline Flex, Pipeline Shield, and FRED flow diverters in an in vitro human blood physiological flow loop model

“…The surface treatment imparts a non‐thrombogenic and biomimetic surface that has also been shown to reduce inflammation and increase early neointimal growth in preclinical studies, in addition to reducing material thrombogenicity and thrombus formation in several studies—in vitro, ex vivo, and in vivo . This is supplemented by recent clinical data supporting the safety of Pipeline Shield with no major stroke or neurological death at 30 days follow‐up . Another device that has recently undergone clinical trial in the US is the FRED (Flow Redirection Endoluminal Device, Microvention) .…”

Safety and efficacy of the Derivo Embolization Device for the treatment of unruptured intracranial aneurysms: a multicentric study

“…To address these limitations, FDDs are continuously being revised technically and novel devices such as the Flow Re-Direction Endoluminal Device (FRED, Microvention, Tustin, California, USA),10 the Pipeline Flex (Covidien),11 and the p64 (Phenox, Bochum, Germany)12 have been introduced to the market. However, while experience with the PED has been extensively reported in the literature, evidence for newer FDDs is still limited.…”