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Device performance evaluated: extensive in vitro testing of the CascadeTM Non-Occlusive Remodeling Net, an innovative new temporary bridging device to aid in treating aneurysms with “no flow arrest”

Last update on May 19, 2020

A new article by Dr Pervinder Bhogal et al in Interventional Neuroradiology (INR) further demonstrates the viability and performance of the CascadeTM Non-Occlusive Remodeling Net (Perflow Medical, Israel), following early clinical experience published in two articles last year in the Journal of NeuroInterventional Surgery (JNIS) and the Journal of Neurosurgery (JNS)

While coil embolisation and endovascular approaches to intracranial aneurysms are generally considered the “gold standard of treatment”, challenges remain concerning the treatment of wide-neck aneurysms or unfavorable aspect ratios. Currently, each of the coiling techniques have possible drawbacks: stent-assisted coiling could require antiplatelet medication and thus increase the risk for patients with ruptured aneurysms, while balloon-assisted coiling can cause a “temporary cessation of anterogradeblood flow” with the potential of “drops in cerebral perfusion”. Thus, the concept of non-occlusive temporary support for coiling embolization is becoming more and more prevalent, combining the advantages of both approaches.

The CascadeTM Non-Occlusive Remodeling Net is a “next-generation temporary bridging device”, “constructed from 42 Nitinol and Platinum wires”, forming “a controllable braided net allowing for excellent visualization and good apposition to the parent vessel”. Its unique design is seen here to offer a “robust protection of the aneurysmal neck and parent vessel as well as inducing significant intra-aneurysmal flow velocity reduction (FVR)”.  As such, the Cascade device could offer “certain advantages over balloons” in assisting in the coiling of aneurysms.

In this article, the authors use in vitro silicon models to test the Cascade device in several aneurysm types, including sidewall and bifurcation aneurysms. Examining coil protrusion into the parent vessel, P. Bhogal et al looked at possible situations during intervention where coils could become “entangled with the braids of the device”, a complication which might not be seen by the operator and cause potential dislodgement of a coil “from the aneurysm during deflation and removal of the device.” After 480 attempted coilings “to determine whether coil prolapse and entanglement was possible”, the authors neither observed “a single episode of coil protrusion through the Cascade mesh, nor coil protrusion into the parent vessel when the Cascade was deployed across the neck of the aneurysms”. They noted, as well, that when the Cascade device “was positioned in one of the branches of the bifurcation aneurysm, there were no instance of coil herniation/protrusion through the device into the parent artery or either of the branches”.

Aneurysm flow assessment demonstrated a flow velocity reduction of “approximately 23% after inflation of the Cascade device”, and existing clinical data leads the authors to suggest that there appears to be no “need for intra-procedural antiplatelet medication”. While the aim of these tests was not specifically on device handling, the Cascade demonstrated easy to manipulate during the coil placement phase, which “could prove useful in vivo.” 

These results are consistent with previously published findings on early clinical experience with the CascadeTM Non-Occlusive Remodeling Net. Dr P. Bhogal et al conclude that “the Cascade device offers robust protection of the aneurysmal neck and parent vessel as well as inducing significant intra-aneurysmal flow velocity reduction”.

 

Perflow - CASCADE tm

 

* Bhogal P, Wong K, Makalanda H., The Cascade device – In vitro tests to assess coil protrusion into the parent vessel. Interv Neuroradiol. 2020 May 11:1591019920925708. doi: 10.1177/1591019920925708. [Epub ahead of print]

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