Table 1.
Information on devices available for intracranial aneurysm management
Device picture | Device name | Manufacture | CE Mark and FDA approval | Korea/China/Japan market | Brief introduction | On-going clinical trials |
---|---|---|---|---|---|---|
Figure 2 A-D | The Woven Endo-Bridge (WEB) | Sequent Medical, Aliso Viejo, CA, USA (http://www.sequentmedical.com/index.html) | CE Mark (2011); USA (investigational use) | China, clinical trial; Korea and Japan, NA | WEB is a self-expanding mesh that can be introduced into intracranial aneurysms and cover the neck of the aneurysm, resulting in blood flow disruption, thrombosis, and occlusion. | CLinical Assessment of WEB® Device in Ruptured aneurYSms (CLARYS) (NCT02687607) |
Figure 2 E, F | Medina embolization device (MED) | Covidien/eV3, Medtronic, Dublin, Ireland (https:// www.ev3.net/neuro/us/) | CE Mark (2014) | NA | MED is a three-dimensional coil with a memory shape, comprising a radiopaque platinum core wire and a braid mesh with petals shape attached to each loop of the core wire. | Medina Embolization Device In Neurovascular Aneurysm Study (MEDINA) (NCT02982200) |
Figure 2 G, H | Barrel vascular remodeling device (VRD) system | Medtronic, Minneapolis, MN, USA (https://www.ev3.net/neuro/us/) | CE Mark (2013) | NA | Barrel is a self-expandable laser-cut stent with a bulged center section designed to treat wide-necked bifurcation aneurysms with a single stent. | The Reverse Barrel™ VRD Intracranial Aneurysm Trial (Barrel) (NCT02125097) |
Figure 2 I-L | PulseRider | Pulsar Vascular (Codman Neuro), Los Gatos, CA, USA (http://www.pulsarvascular.com/) | CE Mark (2013) | NA | PulseRider is a self-expanding nitinol implant designed for treating wide-neck aneurysms arising at vascular bifurcations. | Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction (ANSWER) (NCT02312856) |
Figure 2 M, N | pCONus | Phenox, Bochum, Germany (http://www.phenox.net/) | CE Mark (2014) | NA | The pCONus is a stent designed to treat wide-neck intracranial bifurcation aneurysms. | pCONus Treatment of Wide-Neck Intracranial Aneurysms (pToWin) (NCT02554708) |
Figure 2 O, P | pCANvas | Phenox, Bochum, Germany (http://www.phenox.net/) | NA | NA | pCANvas is an evolution of the pCONus, with additional membrane coverage of the petals (arrows). | NA |
Figure 2 Q | Comaneci | Rapidmedical, Yokneam, Israel | CE Mark (2014) | NA | The Comaneci device is a compliant radiopaque mesh, comparable to a compliant balloon in aneurysm coiling, without the drawback of blocked flow within the parent artery during expansion of the device. | NA |
Figure 2 R-T | eCLIPs | Evasc Medical Systems Corp., Vancouver, BC, Canada (https://www.evasc.com/) | CE Mark (2014); FDA Designating Humanitarian Use Device (2015) | NA | The eCLIPs is a self-expanding, non-circumferential device designed for treating wide-necked bifurcation aneurysms. It has coil retention and flow-disrupting functions. | European eCLIPs™ Safety, Feasibility and Efficacy Study (EESIS) (NCT02607501) |
Figure 2 U-W | Honeycomb microporous covered stent | Corresponding author: Yasuhide Nakayamany@ncvc.go.jp | NA | Japan, clinical trial | The novel honeycomb microporous covered stents were developed for treating large or wide-necked cerebral aneurysms, with the cavernous sinus portion of the internal carotid and vertebrobasilar arteries as the target treatment regions. | Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms (NCVC-CS1_UAN) (NCT02907229) |
CE Mark, European Conformity Mark; FDA, U.S. Food and Drug Administration; NA, not available.