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  • The novel Tenzing 7 delivery catheter designed to deliver intermediate catheters to the face of embolus without crossing: clinical performance predicted in anatomically challenging model

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New devices and techniques
Original research
The novel Tenzing 7 delivery catheter designed to deliver intermediate catheters to the face of embolus without crossing: clinical performance predicted in anatomically challenging model
  1. Andreas Maximilian Frölich1,
  2. Warren Kim2,
  3. Knut Stribrny1,
  4. Olav Jansen3,
  5. Markus Möhlenbruch4,
  6. Istvan Szikora5,
  7. Fritz Wodarg6,
  8. Jens Fiehler7,
  9. Kim Otto8,
  10. Tony Chou8,
  11. Jan Hendrik Buhk1,
  12. Joey English2
  1. 1 Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  2. 2 Radiology, California Pacific Medical Center, San Francisco, California, USA
  3. 3 Department of Radiology and Neuroradiology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Schleswig-Holstein, Germany
  4. 4 Neuroradiology, University Hospital Heidelberg, Heidelberg, Baden-Württemberg, Germany
  5. 5 Neurointerventions, National Institute of Neurosciences, Budapest, Hungary
  6. 6 Department of Radiology and Neuroradiology, Universitatsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany
  7. 7 Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany
  8. 8 Route 92 Medical, Inc, San Mateo, California, USA
  1. Correspondence to Dr Andreas Maximilian Frölich, Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg 20246, Germany; a.froelich{at}uke.de

Abstract

Background In large vessel occlusionstroke, navigation of aspiration catheters (AC) can be impeded by vessel tortuosity and the ophthalmic artery origin. A novel tapered delivery catheter was designed to facilitate delivery without disturbing the embolus. We assessed AC deliverability in vitro and validated the observations in a first-in-human experience.

Methods In a vascular model with three challenging craniocervical scenarios, two commercial AC were advanced from the carotid to the middle cerebral artery by four neurointerventionalists. Catheter deliverability with standard microwire and microcatheter (MC) combinations and the Tenzing 7 (T7) Delivery Catheter (Route 92 Medical, San Mateo, CA) were compared. Operators rated aspects of catheter deliverability on a 5-point scale. Results were compared with device delivery patterns at a neurovascular center before and after clinical introduction of T7.

Results In vitro, success rate and speed were higher with T7 (96%; mean 30±10 s) than with MC (65%; 72±47 s, p<0.001 each), with fewer interactions with the occlusion site (T7: 54% vs MC: 77%, p=0.004). T7 received superior ratings regarding carotid artery deflection (T7: 2, IQR1-3 vs MC: 3, IQR2-3, p<0.001), guide catheter pushback (T7: 2, IQR1-3 vs MC: 3, IQR3-3, p<0.001) and ophthalmic artery passage (T7: 1.5, IQR1-2 vs MC: 4, IQR3-5, p<0.001). Before introduction of T7 at a single center, delivery of AC to a large vessel occlusion without crossing was achieved in 15/123 cases (12%). With T7, this rate was 28/31 patients (90.3%).

Conclusion Compared with microcatheter and microwire combinations, T7 improves aspiration catheter delivery in vitro, minimizing the need to cross the occlusion. Initial clinical experience appears to validate the model’s observations.

  • catheter
  • guidewire
  • stroke
  • thrombectomy
  • intervention

Data availability statement

Data are available upon reasonable request. Data (statistical data and in vitro video files) are available upon reasonable request through our institution’s contact for data sharing (nrad@uke.de).

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/neurintsurg-2020-016412

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    Data availability statement

    Data are available upon reasonable request. Data (statistical data and in vitro video files) are available upon reasonable request through our institution’s contact for data sharing (nrad@uke.de).

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    Footnotes

    • Contributors JF and TC handled funding and supervision. JE, AMF, OJ, MM, IS, FW, KO, JHB and TC performed the experiments. DE, AMF, WK and KS analyzed the data. AMF, JE and WK wrote the manuscript. All authors read and corrected the manuscript.

    • Funding This work was supported by a grant from the German Ministry for Education & Research (BMBF grant #031L0154B). The authors thank Philips Healthcare for the support and realization of the “Hermann Zeumer Research Laboratory” including a Philips Allura Clarity Angiography system.

    • Competing interests ROUTE 92 MEDICAL & TENZING are registered trademarks of Route 92 Medical, Inc. T7 is a trademark of Route 92 Medical, Inc. Catheters and travel support for physicians participating in the laboratory experiments were supplied by Route 92 Medical, Inc.

    • Provenance and peer review Not commissioned; externally peer reviewed.