E-086 First-in-man and pilot multicenter experience with a novel 7F guide catheter, the radical catheter
Bibliographic record
Abstract
Introduction Complex procedures with tortuous vasculature and challenging device delivery often necessitate utilizing multiple catheters, which has become a standard approach. The Radical Catheter is an FDA-cleared 7F guide catheter with ID 0.082’. It is the first example of a catheter constructed with a new design platform that eliminates abrupt transition zones inherent in traditional catheter construction. A more effective guide catheter offers a number of advantages including more stable distal access, faster procedural times, and may even reduce the number of devices needed (such as intermediate catheters) in select procedures. Methods This is a multicenter retrospective study across two academic centers of the first 30 neuroendovascular in-human procedures performed using the 7F Radical Catheter. Characteristics of the patients, procedures, vascular lesions, and adverse events were assessed. Results Thirty patients underwent neuroendovascular procedures performed by 8 operators across 6 hospitals in 2 institutions between 12/20/23 and 2/5/24. 24 elective and 6 emergency procedures were performed including 15 aneurysm embolizations, 5 middle meningeal artery embolizations for chronic subdural hematomas, 3 arteriovenous malformation embolizations, 3 procedures for large vessel occlusions, 1 tumor embolization, 1 dural arteriovenous malformation embolization, 1 diagnostic procedure for idiopathic intracranial hypertension, and 1 cerebrospinal fluid fistula embolization. Twenty procedures were performed via femoral and 10 via radial access. 27 procedures were performed trans-arterial and 3 procedures were performed transvenous. During the procedures, the target vessel was catheterized 100% of the time and there were no device-related adverse events. Moreover, due to the ease of distal access with the Radical Catheter, intermediate catheters were not needed and not used in 15/16 (94%) cases in which the treating physician reported would have normally been used. Discussion In a wide array of neuro-endovascular procedures performed by multiple operators across multiple hospitals, the Radical Catheter performed well by reaching the target vasculature and delivering therapeutic devices and fluids in 100% of cases with no device failures or device-related adverse events. Furthermore, the Radical Catheter appears to reduce the need for intermediate catheters. Disclosures C. Kellner: 1; C; Penumbra, Integra, Viz.AI, Siemens, Longeviti, Irras, ICE Neurosystems, CVAID, Endostream, Microtransponder, Medtronic, Cerenovus. 4; C; Metis Innovative, Precision Recovery, Inc, Borealis, E8, Borvo, Synchron, Proprio, Fluid BioMed, Von Vascular, Phantom Neuro, Radical. T. Shigematsu: None. B. Philbrick: None. H. Tabani: None. T. Caton: None. N. Moore: None. M. Bain: None.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".