June 30, 2022

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The blood flow-guided dense mesh stent Pipeline clinically validated again

Neurosurgery: The blood flow-guided dense mesh stent Pipeline has been clinically validated again, transforming the concept of aneurysm treatment



Neurosurgery: The blood flow-guided dense mesh stent Pipeline has been clinically validated again, transforming the concept of aneurysm treatment

In September 2021, “Neurosurgery” magazine newly released the PEDESTRIAN1 study, which has had a huge impact on the entire neurointerventional academic community.

The PEDESTRIAN study is a large sample size, real-world study with the longest follow-up time for the PipelineTM blood flow-oriented dense mesh stent technology, which once again verifies the effectiveness and safety of the technology. The PipelineTM blood flow guided dense mesh stent technology has also completely changed the concept of intracranial aneurysm treatment.

Intracranial aneurysm (Intracranial aneurysm) is a tumor-like protrusion formed by the localized abnormal changes of cerebral arteries, and it is one of the most common cerebrovascular diseases.

The incidence rate is about 4.05%. It is easy to rupture and hemorrhage. It is the most common cause of spontaneous subarachnoid hemorrhage. Once rupture occurs, about 8%-30% of patients die before seeing a doctor.

If rupture occurs again, the mortality rate is as high as 70%. Early and correct diagnosis and treatment are of great significance for reducing aneurysm rupture rate, disability rate and mortality rate2.

The clinical treatment of aneurysms is mainly surgery, and the specific plans mainly include: endovascular embolization of the aneurysm and craniotomy to clamp the aneurysm2. Since 2002, the former has gradually become the preferred option.

With the passage of time, the endovascular treatment technology for intracranial aneurysms has been continuously upgraded. In 2011, the US FDA approved a new technology, the first generation of PipelineTM blood flow guided dense mesh stent technology.

The PipelineTM blood flow guided dense mesh stent can repair the diseased blood vessel segment where the intracranial aneurysm is located and reconstruct the local artery.

This completely changes the treatment concept of intracranial aneurysm. To a certain extent, it is both a product and a product. Kind of treatment options. The two main mechanisms of action for this technology to treat aneurysms are:

(1) Interfering with the blood flow from the artery-bearing artery into the aneurysm, causing blood stasis in the aneurysm, promoting thrombosis in the aneurysm, and completely occluding it

( 2) As a “scaffold” for vascular endothelial cells to climb and grow, after being covered by endothelial cells, it forms a permanent biological seal at the neck of the aneurysm.

Traditional endovascular coil embolization treatment strategies have certain limitations, because the ultimate goal of treating aneurysms is to permanently occlude the aneurysm, which requires sealing the aneurysm neck and blocking the passage of blood into the aneurysm.

Treatment is more focused on embolizing tumor sacs, just like filling pits in the road with soil and rock; while the blood flow-directed dense mesh stent is different, it can rebuild blood vessels and completely repair the lesions, that is to say, completely resurface the damaged road.

Therefore, it is one of the preferred methods to permanently cure aneurysms3.

The continuous improvement of the blood flow-directed dense mesh stent and the undisputed clinical results have made clinicians widely recognize the clinical value of this technology3.

First, in 2014, the second-generation technology PipelineTM Flex blood flow-directed dense mesh stent technology obtained FDA and CE certification; then in 2015, the third-generation technology PipelineTM Flex with Shield TechnologyTM obtained the European CE certification.

In the Chinese market, in 2017, the second-generation technology PipelineTMFlex blood flow-oriented dense network stent technology obtained China CFDA (now renamed China NMPA) certification, and the technology officially began to serve a large number of patients in China.

The large sample size and high-quality clinical research of the PipelineTM blood flow guided dense mesh stent technology is also constantly developing. Starting from the PITA4 study published in 2011, until the PEDESTRIAN1 study in September 2021, the effectiveness and safety of the technology It has been repeatedly verified by a large number of clinical studies.

*Remark:

1. In the PLUS9 study, the number of individual complications is counted, but the overall complication rate is not counted, so it is not marked here.

2. Safety represents the incidence of major adverse events.

In the past ten years, tens of thousands of patients at home and abroad have received the treatment of this technology and benefited from the advanced medical technology.

In the future, more patients will be treated with this technology to restore their health. Extend the life of real quality.

References:

1. Lylyk I, Scrivano E, etc. Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms, Single-Center Registry: Long-Term Angiographic and Clinical Outcomes from 1000 Aneurysms. Neurosurgery. 2021 Jun 7;89(3):443–9 . doi: 10.1093/neuros/nyab183. Epub ahead of print. PMID: 34098575; PMCID: PMC8374967

2. Wang Yi. Analysis of related risk factors of intracranial aneurysm rupture[D]. Jilin University, 2011.

3. Satoshi Tateshima. Basics of the Flow Diverter: Development and Principles. Journal of Neuroendovascular Therapy 2017; 11(3):105–108. DOI: 10.5797/jnet.ra-diver ter.2016-0027

4. Nelson PK, Lylyk P, etc. The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol. 2011 Jan;32(1):34-40. doi: 10.3174/ajnr.A2421. Epub 2010 Dec 9. PMID: 21148256; PMCID: PMC7964968.

5. Hanel RA, Kallmes DF, etc. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020 Jan;12(1):62-66. doi: 10.1136/neurintsurg -2019-015091. Epub 2019 Jul 15. PMID: 31308197; PMCID: PMC6996098.

6. Becske T, Brinjikji W, etc. Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial. Neurosurgery. 2017 Jan 1;80 (1):40-48. doi: 10.1093/neuros/nyw014. PMID: 28362885.

7. Kallmes DF, Brinjikji W, etc. Aneurysm Study of Pipeline in an Observational Registry (ASPIRe). Interv Neurol. 2016 Jun;5(1-2):89-99. doi: 10.1159/000446503. Epub 2016 May 26. PMID: 27610126; PMCID: PMC4934472.

8. Kallmes DF, Hanel R, etc. International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study. AJNR Am J Neuroradiol. 2015 Jan;36(1):108-15. doi: 10.3174/ajnr.A4111. Epub 2014 Oct 29. Erratum in: AJNR Am J Neuroradiol. 2015 May;36(5):E39-40. PMID: 25355814; PMCID: PMC7965920.

9. Luo B, Kang H, etc. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. PMID: 33224273 ; PMCID: PMC7649855.

The blood flow-guided dense mesh stent Pipeline clinically validated again

(source:internet, reference only)


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