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Demo device profiles

§1.1Demo

Solitaire X / Solitaire Platinum

Medtronic Neurovascular

The Solitaire AB/FR device was the first fully retrievable and self-expanding intracranial stent available, originally designed for stent-assisted treatment of intracranial aneurysms. In 2008, one of the first cases was described in the literature where a Solitaire was used to retrieve an intra-arterial thrombus.

Mechanical ThrombectomyEvidence L1
FDACENMPA
§2.1Demo

Penumbra System: ACE68 / JET 7 / JET 7 Xtra Flex

Penumbra, Inc. (Alameda, CA)

System Overview The latest generation of the Penumbra System features the ACE Reperfusion Catheters, HiFlow Aspiration Tubing, the 3D Revascularization Device, and Pump MAX aspiration pump and accessories. The system represents the original ADAPT platform.

Mechanical Thrombectomy
FDACENMPA
§4.1Demo

Pipeline Flex / Pipeline Vantage with Shield Technology

Medtronic Neurovascular (Irvine, CA)

(Medtronic) Vantage), CE, NMPA | Evidence Level: Level 1 The Pipeline Embolization Device has proven to be a safe and effective device for the treatment of intracranial aneurysms. The Pipeline Vantage Flow Diverter (PVFD) with Shield Technology is the new fourth generation of this implant, with modifications made compared to previous iterations.

AneurysmEvidence L1
FDA (2011 PED2022
§5.1Demo

WEB (Woven EndoBridge) SL / SLS / WEB 17

MicroVention (Terumo) (Aliso Viejo, CA)

2018), CE Mark, NMPA | Evidence Level: Level 1 (WEB-IT, CLARYS, CLEVER, 5-Year Follow-Up Data) 5.1.1 Design and Engineering: Generation Evolution The WEB (Woven EndoBridge) device, manufactured by MicroVention, consists of a selfexpanding nitinol braided mesh structure designed to be deployed within the aneurysm sac. The device has evolved through several generations, beginning with the WEB DL (Du

AneurysmEvidence L1
FDA (December
§8.1Demo

Onyx (Ethylene Vinyl Alcohol Copolymer + DMSO + Tantalum)

Medtronic Neurovascular (Dublin, Ireland / Irvine, CA)

(2005 for AVM; 2007 for Onyx HD-500 for aneurysm), CE | Evidence Level: Level 1 (BRAVO multicenter trial; prospective Onyx vs. n-BCA RCT; EMBOLISE RCT for cSDH 2024) 8.1.1 Chemistry and Physical Behavior Onyx (Medtronic) is a non-adhesive liquid embolic agent composed of an ethylene vinyl alcohol (EVOH) copolymer dissolved in dimethyl sulfoxide (DMSO).

EmbolizationEvidence L1
FDA