Evidence map›Paper›PMID 32487767›Full record

ArticleJournal of neurointerventional surgery2020

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology.

Robert M Starke, John Thompson, Ariana Pagani, Animesh Choubey, John M Wainwright, Michael F Wolf, Reza Jahanbekam, Gaurav Girdhar

Open access · hybridAbstract read
In one paragraph

Article in Journal of neurointerventional surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Angiographic and clinical outcomes from 396 aneurysms treated with the pipeline flex embolization device with shield technology.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Flow diverter surface modifications for aneurysm treatment: A review of the mechanisms and data behind existing technologies.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Observational
  14. Article
  15. Review
  16. Intraluminal Flow Diverter Design Primer for Neurointerventionalists.AJNR. American journal of neuroradiology · 2024
    Review
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Robert M StarkeUniversity of Miami Miller School of Medicine, Miami, Florida, USA.
John ThompsonUniversity of Miami Miller School of Medicine, Miami, Florida, USA.
Ariana PaganiNeurovascular, Medtronic plc, Irvine, California, USA.
Animesh ChoubeyNeurovascular, Medtronic plc, Irvine, California, USA.
John M WainwrightNeurovascular, Medtronic plc, Irvine, California, USA.
Michael F WolfCore Technologies, Medtronic plc, Minneapolis, Minnesota, USA.
Reza JahanbekamCore Technologies, Medtronic plc, Minneapolis, Minnesota, USA.
Gaurav GirdharNeurovascular, Medtronic plc, Irvine, California, USA gaurav.girdhar@medtronic.com.
Medtronic (United States) · USUniversity of Miami · US

Funding

Miami Clinical and Translational Science InstituteUL1TR002736 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI CARRASQUILLO, OLVEEN, KOBETZ, ERIN N · 2018 to 2022
$23.2M
Institutional Career Development CoreKL2TR002737 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI RUNDEK, TATJANA, SCOTT, GWENDOLYN BARBARA · 2018 to 2022
$3.6M
Endothelial cell dysfunction in cerebral aneurysm pathogenesisR01NS111119 · NINDS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI STARKE, ROBERT MICHAEL · 2020 to 2024
$2.4M
NCATS NIH HHS KL2 TR002737NCATS NIH HHS UL1 TR002736NINDS NIH HHS R01 NS111119
6 · The paper itself

Abstract

backgroundThe Pipeline Vantage Embolization Device with Shield Technology is a next generation flow diverter developed to improve aneurysm occlusion and implant endothelialization in addition to lowering thrombogenicity. We report here the in vivo biocompatibility and in vitro hemocompatibility performance of the Pipeline Vantage Embolization Device with Shield Technology (Vantage) compared with the Pipeline Flex Embolization Device (Flex).

methodsBiocompatibility (via histology), aneurysm occlusion and vessel patency (via angiography), and endothelial coverage (via scanning electron microscopy (SEM)) for the Vantage and Flex devices were assessed in the rabbit elastase aneurysm model at 90 days (n=29) and 180 days (n=27). In vitro thrombogenicity for Flex and Vantage (n=16) was assessed using a human blood flow loop model at low heparin concentration (0.6 U/mL) with thrombin generation, platelet activation and thrombus visualization as outputs.

resultsRaymond Roy Occlusion Classification grade 1 was higher for Vantage (61%) compared with Flex (46%), but was not statistically significant (p>0.05). All branch vessels were patent. Histological measures for both devices were similar (p>0.05). Endothelial coverage of the implant was significantly better for Vantage compared with Flex (p<0.05). In vitro measurements of thrombin generation (thrombin-antithrombin complex (µg/mL): Vantage 0.49±0.45; Flex 10.57±9.84) and platelet activation (β-thromboglobulin (IU/µl): Vantage 0.41±0.19; Flex 4.14±2.38) were both statistically lower (p

conclusionVantage improved aneurysm occlusion and implant endothelialization and had significantly lower thrombogenicity as compared with Flex, while preserving the biocompatibility safety profile of Flex.

Indexed as

Blood Vessel ProsthesisAnimalsEmbolization, TherapeuticHemodynamicsHumansIntracranial AneurysmPlatelet ActivationRabbitsTreatment Outcomeaneurysmflow diverter

Identifiers

PMID32487767
PMCPMC7509525
OpenAlexW3028809964

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.